Weeks Of Participation Research Articles

Integration of Rehabilitation Activities Into Everyday Life Through Telerehabilitation: Qualitative Study of Cardiac Patients and Their Partners.

BackgroundImplementation of cardiac rehabilitation has not been optimal, with patient participation rates below 50%. Factors that contribute to cardiac patients’ lack of participation in rehabilitation programs are patient motivation, logistical difficulties in getting to the rehabilitation facilities, lack of psychosocial elements, and individualization of activities in the rehabilitation programs. Telerehabilitation has been proposed as a new way to address the challenge of engaging and motivating cardiac patients and their partners to participate in rehabilitation.ObjectiveThe aim of this study was to explore the experiences of cardiac patients and their partners of participating in the Teledialog Telerehabilitation Program (TTP). The Teledialog program consisted of a digital rehabilitation plan, transmission of health data from patient’s home to hospital and health care center, and an interactive Web portal with information and training videos.MethodsThis case study used a theoretical approach combining the “community of practice” approach and self-determination theory. A triangulation of data collection techniques was used, including documents, participant observation (72 hours), and qualitative interviews with cardiac patients and their partners enrolled in the telerehabilitation group. A total of 14 cardiac patients, 12 patient spouses/partners, and 1 son participated in the study. The participants were interviewed at enrollment in the telerehabilitation program and after 12 weeks of participation in the program. Interview data were analyzed using NVivo 11.0.ResultsPatients and their partners found the Web portal ActiveHeart.dk and the electronic rehabilitation (e-rehabilitation) plan to be helpful tools for health education, coordinating rehabilitation goals, creating an overview of the data, and ensuring continuity in the rehabilitation process. The patients felt that the TTP treated them as individuals, gave them a sense of autonomy, and provided enhanced relatedness to health care professionals and partners and a sense of competence as active participants in their own rehabilitation process. Some patients missed being part of a community of practice with other cardiac patients and did not use the Web forum. Patients’ partners found that the telerehabilitation program gave them a sense of security and helped them balance their involvement as a partner to the patient and not push the patient too hard.ConclusionsCardiac patients and their partners found telerehabilitation technologies a useful digital toolbox in the rehabilitation process. Telerehabilitation motivated the patients to integrate rehabilitation activities into their work schedule and everyday life and made them feel like unique individuals. Participating in the Teledialog Telerehabilitation Program might not be a suitable strategy for all cardiac patients. Being a patient’s partner in the telerehabilitation program was associated with a heightened sense of security, navigation between active involvement in the rehabilitation process, being an equal partner, and not pushing the patient too hard.

Single intra-articular injection of TLC599 provided sustained pain relief through 24 weeks in participants with symptomatic knee osteoarthritis

Single intra-articular injection of TLC599 provided sustained pain relief through 24 weeks in participants with symptomatic knee osteoarthritis

Effect of Two Complementary Mass-Scale Media Interventions on Handwashing with Soap among Mothers

Poor handwashing behavior is a major cause of morbidity and mortality globally. We evaluated two complementary mass-scale media interventions targeting mothers to increase the frequency of handwashing with soap; one using TV advertising, and the other mobile phone messaging. Television Commercials (TVCs): Mothers of 4–12 year-old children (n = 756) were randomly allocated among four arms: Three different branded TVCs and a fourth, control TVC unrelated to handwashing. TVCs were embedded in blocks of unrelated commercials and shown once a week over four weeks in participants’ own homes. Mobile messages: New mothers (n = 598) and mothers of 4–7 year-old children (n = 501) were enrolled in a treatment or control arm. Mothers in the treatment arm received branded mobile phone messages twice weekly for 8 weeks (new mothers) or 4 weeks (mothers of 4–7 year-olds). For TVCs, there were higher rates of handwashing with soap at key occasions in the first (RR: 1.33, p = .002) and second (RR: 1.26, p = .041) of three treatment arms, or 0.4 additional handwashes with soap on key occasions daily. In the mobile study, new mothers (adj-RR: 1.04, p = .035) and general mothers (RR: 1.07, p = .007) receiving the intervention were more likely to wash their hands with soap on key occasions than those in the control group, corresponding to 1.3 and 1.0 more occasions daily. These interventions were associated with significantly greater handwashing with soap, consistent with the hypothesis that branded mass communications can impact habitual lifestyle behaviors relevant to public health.

Effect of Prompts for Restructuring Oral Muscular Phonetic Targets (PROMPT) on Compensatory Articulation in Children With Cleft Palate/Lip.

Objective. This investigation researched the effectiveness of the PROMPT (Prompts for Restructuring Oral Muscular Phonetic Targets) method to address compensatory articulation errors in children with cleft palate. Design. Single-subject AB multiple baselines across participants and behaviors. Setting. Pediatric outpatient rehabilitation department in a local hospital in a metropolitan city. Participants. The investigation consisted of 3 participants (ages = 4:4 to 12:8) born with bilateral complete cleft lip and palate. All participants underwent several reconstructive surgeries to repair their lips and palates. Interventions. The PROMPT treatment was provided for 45 minutes 3 times a week for 4 weeks (3 weeks for Participant 2). Main Outcome Measure. Therapy sessions addressed anterior lingual speech motor phonemes across 3 tiers (syllables, words, and phrases). Results. Direct visual observation of data obtained throughout this investigation indicate potential positive effects and significant correlation between improvements in sound production at 3 tiers and the implementation of the PROMPT technique. Speech intelligibility was judged by 3 blinded listeners who were unfamiliar with children with speech disorders or with cleft palate speech. All listeners identified and judged improvement in overall speech intelligibility over the course of this investigation. Listeners examined speech samples selected from sessions 3, 6, 9, and 12. Conclusion. The findings in this investigation provide a potential relationship on the effectiveness of the PROMPT method and attainment of accurate speech productions in children with cleft palate producing compensatory articulation errors, resulting in improvement in overall speech intelligibility.

Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older.

Background: In elderly individuals aged ≥65 years with hepatitis C virus (HCV) infection, efficacious and safe HCV therapy is complicated by frequent comorbidities and concomitant medications. The aim of this analysis was to evaluate the efficacy and safety of elbasvir/grazoprevir (EBR/GZR) in people aged ≥65 years. Methods: This is an integrated retrospective analysis of EBR/GZR administered for 12 weeks in participants with HCV genotype 1 or 4 infection enrolled in 12 Phase 2/3 clinical trials. The primary end point was sustained virologic response 12 weeks after completing therapy (SVR12; HCV RNA below the lower limit of quantification). Results: Most participants aged ≥65 years were receiving ≥1 concomitant medication (322/339; 95.0%) and had ≥1 comorbidity (334/339; 99%). SVR12 rates were 95.3% (323/339) in participants aged ≥65 years and 95.4% (2,041/2,139) in those aged <65 years. Rates of adverse events, drug-related adverse events, serious adverse events, and discontinuations were similar in participants aged ≥65 years and those aged <65 years. In participants aged ≥65 years, median estimated glomerular filtration rate was similar at baseline and at the end of treatment. Conclusion: The efficacy and safety of EBR/GZR were similar in participants with HCV infection aged ≥65 years and those aged <65 years.

Help-seeking behaviour of individuals with mental illness before pursuing professional mental health care services in Lagos, Nigeria

Introduction: Due to the social stigma associated with mental illness, to avoid the sigma, individuals with mental illness opt to seek help from variety of sources before eventually accessing professional mental health care. This study investigated the help-seeking behaviours, delays to psychiatric care and the association between help-seeking pattern and sociodemographic characteristics of mentally-ill patients visiting a teaching hospital in Lagos. Methods: A total number of 94 patients seen at the outpatient's clinic of the department of psychiatry of Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria for the first time were recruited for the study. They were interviewed with the ICD-10 and World Health Organization Pathway Encounter Form for psychiatric care. Results: Three major help-seeking gateways to professional psychiatric care were identified. Majority of the participants 63% patronised the indirect routes while about one third 37.3% sought for direct professional psychiatric care. Depression and schizophrenia were the commonest diagnoses. The delays ranged from 3 weeks to 44 weeks for those that patronised the direct route and 2 weeks to 416 weeks for participants who utilised the indirect routes. Depression (X2=0.03, p=0.84), schizophrenia (X2=0.39, p= 0.53), neurotic disorder (X2=0.46, p= 0.49), and mania (X2=1.29; p= 0.25) were more prevalent in females although the relationship between the sex distribution were not statistically significant. Conclusion: The help-seeking behaviours of mentally-ill patients in Lagos Nigeria were predominantly the indirect routes. There is an urgent need for regular public education, advocacy and awareness mental health campaigns to provide knowledge about the aetiologies of mental illness to further to reduce the social stigma associated with mental illness. The local, state and federal governments of Nigeria should as a matter of urgency integrate mental healthcare into primary healthcare.

The WorkingWell Mobile Phone App for Individuals With Serious Mental Illnesses: Proof-of-Concept, Mixed-Methods Feasibility Study.

BackgroundThe disparities in employment for individuals with serious mental illnesses have been well documented, as have the benefits of work. Mobile technology can provide accessible in-the-moment support for these individuals. The WorkingWell mobile app was developed to meet the need for accessible follow-along supports for individuals with serious mental illnesses in the workplace.ObjectiveWe explore the usability, usage, usefulness, and overall feasibility of the WorkingWell mobile app with individuals with serious mental illnesses who are actively employed and receiving community-based services.MethodsIn this proof-of-concept, mixed-methods, 2-month feasibility study (N=40), employed individuals with serious mental illnesses were recruited in mental health agencies. Participants completed surveys regarding background characteristics and cellphone use at enrollment and responded to interview items regarding app usability, usage, and usefulness in technical assistance calls at 1, 2, 4, and 6 weeks of participation and in the exit interview at 8 weeks. Data on the frequency of app usage were downloaded on a daily basis. A version of the System Usability Scale (SUS) was administered in the exit interview. Overall feasibility was determined by the percent of users completing the study, responses to an interview item regarding continued use, and findings on usability, usage, and usefulness. General impressions were obtained from users regarding user support materials, technical assistance, and study procedures.ResultsMost participants were male (60%, 24/40), aged 55 or younger (70%, 28/40), white (80%, 32/40), had less than a 4-year college education (78%, 31/40), were employed part-time (98%, 39/40), had been working more than 6 months (60%, 24/40), and indicated a diagnosis of bipolar, schizoaffective, or depressive disorder (84%, 16/25). The majority of participants owned cellphones (95%, 38/40) and used them multiple times per day (83%, 33/40). Their average rating on SUS usability items was 3.93 (SD 0.77, range 1.57-5.00), reflecting positive responses. In general, participants indicated WorkingWell was “very easy,” “straightforward,” “simple,” and “user friendly.” Usability challenges were related to personal issues (eg, memory) or to difficulties with the phone or app. Data on app usage varied considerably. The most frequent navigations were to the home screen, followed by Rate My Day and My Progress, and then by Manage the Moment and Remind Me. The app was described as useful by most participants; 86% (30/35) agreed the app would help them manage better on the job. Of the 40 original participants, 35 (87%) completed the study.ConclusionsThe WorkingWell app is a feasible approach to providing accessible, as-needed employment support for individuals with serious mental illnesses. The app would benefit from modifications to address recommendations from feasibility testing. Controlled research with larger samples, more diverse in individual characteristics and workplace settings, is essential to demonstrating the effectiveness of the app.

Nebulised hypertonic saline for cystic fibrosis.

Background Impaired mucociliary clearance characterises lung disease in cystic fibrosis (CF). Hypertonic saline (HS) enhances mucociliary clearance in vitro and may lessen the destructive inflammatory process in the airways. Objectives To investigate the effects of nebulised HS in CF compared to placebo or other treatments for mucociliary clearance. Search methods We searched the Cochrane CF and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. Most recent search: 31 July 2008. Selection criteria Controlled trials assessing HS compared to placebo or other mucolytic therapy, for any duration or dose regimen in people with CF (any age or disease severity). Data collection and analysis Two authors independently reviewed all identified trials and data; and assessed trial quality. Main results Twelve trials (442 participants, aged 6 to 46 years) were included; five excluded and two await classification. In two placebo-controlled trials, HS (3% to 7%, 10 ml twice-a-day) significantly increased forced expiratory volume at one second (FEV1) at four weeks, mean difference (MD) 4.15 (95% CI 1.14 to 7.16); but not significantly after 48 weeks, MD 2.31 (95% CI -2.72 to 7.34). Two trials compared a similar dose of HS to recombinant deoxyribonuclease (RhDNAse). One three-week trial showed a non-significant difference, MD 1.60 (95% CI -7.96 to 11.16). However, in the second trial, after 12 weeks, RhDNAse led to a greater increase in FEV1 than HS (5 ml twice-daily), in participants with moderate to severe lung disease, MD 8.00 (95% CI 2.00 to 14.00). One 48-week placebo-controlled trial showed significant improvements in frequency of antibiotic use and quality of life; also that HS did not increase the concentration of Pseudomonas aeruginosa or Staphylococcus aureus. Authors' conclusions Treatment with 7% HS for 48 weeks showed a small improvement in FEV1 at four weeks; however, this was not sustained at 48 weeks (primary outcome measure of the only long-term trial). Unlike RhDNAse, HS can't, in the long term, be said to improve lung function. However, it did improve quality of life and reduce pulmonary exacerbations. Delivered following a bronchodilator, HS appears inexpensive and safe with no increased infection risk. We believe there is sufficient evidence to recommend using HS in CF; qualifying this we highlight that the only long-term trial failed to demonstrate a significant difference in its primary outcome (lung function) with improvements only in secondary outcomes.

Remini-Sing: A Feasibility Study of Therapeutic Group Singing to Support Relationship Quality and Wellbeing for Community-Dwelling People Living With Dementia and Their Family Caregivers.

Background: Living at home following a diagnosis of dementia can be difficult for both the person living with dementia (PwD) and their family caregivers (FCG). Active group music participation may provide an avenue for emotional release, offer psychosocial support to caregivers and stimulate meaningful interaction between caregivers and loved ones with dementia. Therapeutic music interventions also have the capacity to facilitate reminiscence and social engagement and can help to manage challenging symptoms associated with dementia, such as anxiety, apathy, and agitation.Method: This feasibility study examined the acceptability of a 20-week therapeutic group singing intervention (Remini-Sing) and quantitative research assessments for PwD/FCG dyads living in the community. Quantitative measures for the following outcomes were tested for sensitivity and acceptability: relationship quality (PwD and FCG); life satisfaction, caregiver satisfaction, flourishing, and depression for FCGs; and anxiety, apathy, agitation, and quality of life for PwD. Quantitative assessments were conducted before, during (midway) and after 20 weeks of participation in a therapeutic singing group attended by the PwD and FCG together. The Remini-Sing intervention incorporated vocal warm ups, singing familiar songs, learning new songs, and opportunities for social interaction. Qualitative interviews were conducted with all dyads that completed the intervention.Results: Twelve PWD/FCG dyads were recruited and enrolled in the study. High participation and retention rates indicated that the intervention was received favorably by participants. There were no statistically significant changes on measures from pre to post intervention. However, favorable baseline scores on relationship quality and wellbeing measures were sustained over the 20-week intervention. The testing of these measures for feasibility also revealed that some were too difficult for PwD and thus yielded questionable results, some were potentially less relevant, and there were likely floor and ceiling effects on several of the measures utilized.Conclusions: This study demonstrated good feasibility for a research protocol and therapeutic group singing intervention for community-dwelling PwD and their FCGs. Participant reflections and researcher observations yielded useful information guiding the selection of quantitative outcome measures for future research in this area.

“Treatment is not yet necessary”: delays in seeking access to HIV treatment in Uganda and Zimbabwe

We examined the logic that individuals use to account for delaying HIV testing and/or initiating HIV treatment. Our qualitative study, situated within the REALITY trial (Reduction of EArly mortaLITY in HIV infected adults and children starting antiretroviral therapy), was conducted in Uganda and Zimbabwe in 2015. Forty-eight participants (different age groups, sex and viral load/WHO disease stage) were included. Each participant had 2 interviews (1 after 4 weeks of participation in the trial the other after 12 weeks). If a person could manage presenting symptoms, they felt they had “more time” before starting antiretroviral therapy (ART). Their reluctance to have an HIV test (despite deteriorating health) arose from a belief that they were not “sick”, that treatment was “not yet necessary”. People in our study did not consider themselves as presenting “late”, and treatment was not considered urgent as long as they considered their health to be “good enough”.

Changes in HbA1c with Optimization of Metformin Dosage in the GRADE Cohort

Delay in maximizing metformin (MET) therapy is a common problem - attributed to “clinical inertia” - which might be reduced if there were better understanding of the impact of increasing MET in persons already on MET at submaximal dosage. We determined the effect of optimizing MET dosage on glycemic control in GRADE study participants. We examined the HbA1c of 6767 participants before and after a run-in period, during which MET dosage was adjusted to 2000 mg daily, or a maximally tolerated lower dose. The run-in was 6-14 weeks for participants taking MET at a dose other than 2000 mg/day, or &amp;gt;4 weeks if on 2000 mg/day at entry. To be eligible, participants had to have type 2 diabetes &amp;lt;10 years and HbA1c &amp;gt;6.8% while taking &amp;gt;500 mg of MET daily and no other glucose-lowering drug. Participants also received diet and exercise counseling. Increases in MET dosing during run-in were associated with a progressive fall in HbA1c (p&amp;lt;0.001). The mean decrease in HbA1c was 0.5 ± 1.1% (SD) in participants whose MET was increased by &amp;lt;500 mg/day, 0.5 ± 0.9% for an increase of 500-999 mg/day, and 0.7 ± 1% for an increase of &amp;gt;1000 mg/day. There was also a mean HbA1c decrease of 0.4 ± 0.9% if MET dosage was kept at 2000 mg/day (n=3472), and a mean HbA1c decrease of 0.2 ± 0.7% if the daily dose was decreased (from a mean of 2213 to 1612 mg/day, n=187) - possibly reflecting better adherence to medications and/or lifestyle recommendations. In subjects whose MET dosage was increased (n=3108), the decrease in HbA1c was inversely and strongly correlated with the initial HbA1c at entry (p&amp;lt;0.001, r=-0.53). Conclusions: Maximizing MET dosage can improve glycemic control in persons with type 2 diabetes who have HbA1c values above 6.7% while taking less than 2000 mg of MET daily, and maximizing MET dosage produces a larger fall in HbA1c if the initial HbA1c is higher. Moreover, a decrease in MET dosage did not increase HbA1c. These findings support health policies aimed to improve and optimize use of metformin among persons with type 2 diabetes whose glycemic control is suboptimal. Disclosure W. Sivitz: None. L.S. Phillips: Other Relationship; Self; DIASYST Inc.. Research Support; Self; Amylin Pharmaceuticals, Eli Lilly and Company, Novo Nordisk Inc., Sanofi-Aventis, PhaseBio Pharmaceuticals, Inc., Roche Diabetes Care Health and Digital Solutions, AbbVie Inc., Vascular Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., GlaxoSmithKline plc., Pfizer Inc.. Other Relationship; Self; Novartis Pharmaceuticals Corporation, Merck &amp; Co., Inc.. S.P. Fortmann: None. D.J. Wexler: None. A.W. Camp: None. M. Tiktin: None. M. Perez: None. J.E. Craig: None. P. Hollander: Advisory Panel; Self; Novo Nordisk Inc., Eli Lilly and Company, Merck &amp; Co., Inc. A. Cherrington: Advisory Panel; Self; AstraZeneca. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Novo Nordisk Inc. V.R. Aroda: Consultant; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc., AstraZeneca, Calibra Medical, Eisai Inc., Sanofi. Consultant; Self; Sanofi. Research Support; Self; Theracos, Inc.. Employee; Spouse/Partner; Merck &amp; Co., Inc.. Other Relationship; Self; American Diabetes Association. Consultant; Self; ADOCIA. M. Tan: Other Relationship; Self; Eli Lilly and Company. J. Krakoff: None. N. Rasouli: Consultant; Self; AstraZeneca, Intarcia Therapeutics, Inc.. N. Younes: None. G. Research Group: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung, and Blood Institute. Other Relationship; Self; Bristol-Myers Squibb Company, Merck &amp; Co., Inc., Novo Nordisk Inc., Sanofi-Aventis, Roche Diagnostics Corporation, Becton, Dickinson and Company, Centers for Disease Control and Prevention, National Diabetes Education Program.

Fluvastatin for lowering lipids.

Fluvastatin is thought to be the least potent statin on the market, however, the dose-related magnitude of effect of fluvastatin on blood lipids is not known. Primary objectiveTo quantify the effects of various doses of fluvastatin on blood total cholesterol, low-density lipoprotein (LDL cholesterol), high-density lipoprotein (HDL cholesterol), and triglycerides in participants with and without evidence of cardiovascular disease.Secondary objectivesTo quantify the variability of the effect of various doses of fluvastatin.To quantify withdrawals due to adverse effects (WDAEs) in randomised placebo-controlled trials. The Cochrane Hypertension Information Specialist searched the following databases for randomised controlled trials up to February 2017: the Cochrane Central Register of Controlled Trials (CENTRAL) (2017, Issue 1), MEDLINE (1946 to February Week 2 2017), MEDLINE In-Process, MEDLINE Epub Ahead of Print, Embase (1974 to February Week 2 2017), the World Health Organization International Clinical Trials Registry Platform, CDSR, DARE, Epistemonikos and ClinicalTrials.gov. We also contacted authors of relevant papers regarding further published and unpublished work. No language restrictions were applied. Randomised placebo-controlled and uncontrolled before and after trials evaluating the dose response of different fixed doses of fluvastatin on blood lipids over a duration of three to 12 weeks in participants of any age with and without evidence of cardiovascular disease. Two review authors independently assessed eligibility criteria for studies to be included, and extracted data. We entered data from placebo-controlled and uncontrolled before and after trials into Review Manager 5 as continuous and generic inverse variance data, respectively. WDAEs information was collected from the placebo-controlled trials. We assessed all trials using the 'Risk of bias' tool under the categories of sequence generation, allocation concealment, blinding, incomplete outcome data, selective reporting, and other potential biases. One-hundred and forty-five trials (36 placebo controlled and 109 before and after) evaluated the dose-related efficacy of fluvastatin in 18,846 participants. The participants were of any age with and without evidence of cardiovascular disease, and fluvastatin effects were studied within a treatment period of three to 12 weeks. Log dose-response data over doses of 2.5 mg to 80 mg revealed strong linear dose-related effects on blood total cholesterol and LDL cholesterol and a weak linear dose-related effect on blood triglycerides. There was no dose-related effect of fluvastatin on blood HDL cholesterol. Fluvastatin 10 mg/day to 80 mg/day reduced LDL cholesterol by 15% to 33%, total cholesterol by 11% to 25% and triglycerides by 3% to 17.5%. For every two-fold dose increase there was a 6.0% (95% CI 5.4 to 6.6) decrease in blood LDL cholesterol, a 4.2% (95% CI 3.7 to 4.8) decrease in blood total cholesterol and a 4.2% (95% CI 2.0 to 6.3) decrease in blood triglycerides. The quality of evidence for these effects was judged to be high. When compared to atorvastatin and rosuvastatin, fluvastatin was about 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin at reducing LDL cholesterol. Very low quality of evidence showed no difference in WDAEs between fluvastatin and placebo in 16 of 36 of these short-term trials (risk ratio 1.52 (95% CI 0.94 to 2.45). Fluvastatin lowers blood total cholesterol, LDL cholesterol and triglyceride in a dose-dependent linear fashion. Based on the effect on LDL cholesterol, fluvastatin is 12-fold less potent than atorvastatin and 46-fold less potent than rosuvastatin. This review did not provide a good estimate of the incidence of harms associated with fluvastatin because of the short duration of the trials and the lack of reporting of adverse effects in 56% of the placebo-controlled trials.

12주간 수중재활운동 프로그램 참여가 정신지체아의 신체활동 능력에 미치는 영향

12주간 수중재활운동 프로그램 참여가 정신지체아의 신체활동 능력에 미치는 영향

Efficacy, safety, and tolerability of dolutegravir-rilpivirine for the maintenance of virological suppression in adults with HIV-1: phase 3, randomised, non-inferiority SWORD-1 and SWORD-2 studies

Lifelong HIV antiretroviral therapy (ART) has prompted an interest in two-drug regimens to minimise cumulative drug exposure and toxicities. The safety, tolerability, and efficacy of dolutegravir and rilpivirine suggest potential compatibility and effectiveness as a two-drug regimen. We aimed to investigate this two-drug regimen in a phase 3 study. We identically designed SWORD-1 and SWORD-2, which were open-label, parallel-group, multicentre, phase 3, randomised, non-inferiority studies in 12 countries evaluating efficacy and safety of once-daily dolutegravir 50 mg plus rilpivirine 25 mg versus current ART regimen (CAR). We included participants aged 18 years or older who were on first or second ART with stable plasma HIV-1 RNA (viral load <50 copies per mL) for 6 months or longer at screening. We randomly assigned participants (1:1) with stratification by third-agent class, age, and planned participation in a bone mineral density substudy. The primary endpoint was proportion of participants with viral load lower than 50 copies per mL at week 48 among those individuals who received one or more doses of study medication. Investigators monitored adverse events to assess safety. These trials are registered with ClinicalTrials.gov, numbers NCT02429791 (SWORD-1) and NCT02422797 (SWORD-2). We screened for participants from April 14, 2015, to Oct 15, 2015, for SWORD-1 and from April 21, 2015, to Sept 25, 2015, for SWORD-2. We randomly assigned 516 participants to dolutegravir-rilpivirine and 512 to continue with CAR. At week 48 (last patient visit was Nov 22, 2016), in the pooled analysis of the intention-to-treat population, 95% of participants had viral loads lower than 50 copies per mL in each group (486 of 513 in the dolutegravir-rilpivirine group vs 485 of 511 in the CAR group), with an adjusted treatment difference of -0·2% (95% CI -3·0 to 2·5) and showed non-inferiority with a predefined margin of -8%. 395 (77%) of 513 participants in the dolutegravir-rilpivirine group and 364 (71%) of 511 participants in the CAR group reported adverse events. The most common adverse events were nasopharyngitis (49 [10%] for dolutegravir-rilpivirine vs 50 [10%] for CAR) and headache (41 [8%] vs 23 [5%]). More participants taking dolutegravir-rilpivirine (17 [3%]) reported adverse events leading to withdrawal than did participants taking CAR (three [<1%]). Dolutegravir-rilpivirine was non-inferior to CAR over 48 weeks in participants with HIV suppression and showed a safety profile consistent with its components. Results support the use of this two-drug regimen to maintain HIV suppression. ViiV Healthcare and Janssen Pharmaceutica NV.

An Eight-Week Supervised Fitness Program in Reducing Cardiovascular Risk Factors Among African-American College Students

Cardiovascular disease (CVD) is the leading cause of death of all races in the United States. African-Americans are more likely to die from CVD than whites. One hundred and forty-six African-Americans college students were recruited from a historical black college (HBCU) in North Carolina. A fitness course (PEDU 1541) was required for all students at North Carolina Central University (NCCU). An eight-week program was designed by several certified fitness instructors who teach this course at NCCU. This study was to exam the effectiveness of an 8-week exercise program in reducing CVD risk factors, including cardiovascular fitness, waist circumferences, and body fat percentage (BF%). Students’ BMI, body composition, cardiovascular fitness, muscular endurance, and trunk flexibility were assessed before and after completion of this 8-week supervised program. All the pre- and post-measurements of the 146 students were compared with a paired-t test to see if there were any significant changes. After 8 weeks of participation in this program, all measurements except their body fat composition improved (p< 0.05). Students’ diet or calorie intake was not controlled during the program in this study. Therefore, no significant change was found in their answers to the modified questionnaire of health behaviors, including alcohol, tobacco, vegetable consumptions before and after they completed this 8-week fitness course. Therefore, increase physical activity level alone may not be sufficient to reduce all risks of CVD in African-American population.

Improved Exercise-Related Skeletal Muscle Oxygen Consumption Following Uptake of Endurance Training Measured Using Near-Infrared Spectroscopy.

Skeletal muscle metabolic function is known to respond positively to exercise interventions. Developing non-invasive techniques that quantify metabolic adaptations and identifying interventions that impart successful response are ongoing challenges for research. Healthy non-athletic adults (18–35 years old) were enrolled in a study investigating physiological adaptations to a minimum of 16 weeks endurance training prior to undertaking their first marathon. Before beginning training, participants underwent measurements of skeletal muscle oxygen consumption using near-infrared spectroscopy (NIRS) at rest (resting muscleO2) and immediately following a maximal exercise test (post-exercise muscleO2). Exercise-related increase in muscleO2 (ΔmO2) was derived from these measurements and cardio-pulmonary peakO2 measured by analysis of expired gases. All measurements were repeated within 3 weeks of participants completing following the marathon and marathon completion time recorded. MuscleO2 was positively correlated with cardio-pulmonary peakO2 (r = 0.63, p < 0.001). MuscleO2 increased at follow-up (48% increase; p = 0.004) despite no change in cardio-pulmonary peakO2 (0% change; p = 0.97). Faster marathon completion time correlated with higher cardio-pulmonary peakO2 (rpartial = −0.58, p = 0.002) but not muscleO2 (rpartial = 0.16, p = 0.44) after adjustment for age and sex [and adipose tissue thickness (ATT) for muscleO2 measurements]. Skeletal muscle metabolic adaptions occur following training and completion of a first-time marathon; these can be identified non-invasively using NIRS. Although the cardio-pulmonary system is limiting for running performance, skeletal muscle changes can be detected despite minimal improvement in cardio-pulmonary function.

척수장애인의 건강정보이해능력과 운동참여의 관련성

The purpose of this study is to analyze the relationship between health literacy(HL) and exercise participation by the people with spinal cord injuries, in order to provide basic data for promoting their exercise participation and extension. The subjects of this study were 230 people over age 19 with spinal cord injuries visiting the rehabilitation support center of the Korea Spinal Cord Injruy Association. Logistic regression analysis was used to analyze the relationship between HL and exercise participation. Statistical significance was set at p＜.05. The results of the study are as follows. As for the exercise participation and non participation, odds ratio(OR) of exercise participating group with HL on the borderline was 3.170, which was statistically significant relative to the group with inadequate HL. And OR for exercise participating group with adequate HL was 2.347 relative to the group with inadequate HL, which was statistically significant. As for the exercise period, only more than 12 months of participation demonstrated significance in the groups with borderline HL compared to the group with inadequate HL. OR was 3.465 which was statistically significant, relative to the group with inadequate HL. Finally, as for the exercise frequency, more than 3 to 6 per week of participation demonstrated significance in the groups with borderline HL compared to the group with inadeuqate HL. OR was 3.921 which was statistically significant, relative to the group with inadequate HL. The exercise time was not statistically significant.BR Therefore, regular education is needed to improve the understanding of the health–related information of the people with spinal cord injuries and through such initiatievs, it may be possible to increase the length of participation in the exercise as a result of sufficient communication between experts and participants.

Through the looking glass of Bhils - How Markets win what the State has lost in the desert jungles of Western Rajasthan

Based on the author’s field work in western Rajasthan, this paper forwards the argument that the growing chasm between its promises and delivery has made the state lose its credibility among the Bhils of western Rajasthan in India. The interviews and observations are based on twelve weeks of participation in the daily life of multiple actors in desert jungles of Jodhpur and Bikaner western Rajasthan. The main motive was to understand various postures on hunting- as a community activity as well as a legal input behind certain modern state laws. Still waiting for basic amenities such as reliable supply of water and electricity, forest communities as Bhils also remain unhappy with the way the power politics amongst caste plays out to suppress their ascent into public offices. Many practices of the state remain out of bounds for them. In as far as evoking from the state a moral-functional response over its failings is concerned, Bhils see no light at the end of the day either. They substantiate this by pointing out that, perhaps, their demands, requirements and expectations from the state still remain pretty much the same as the promises in the inaugural election manifestos of parties post-independence. However, although they find it hard to reach the state, its reciprocal reach towards intervening in day to day lives of the communities remains much more than its own ability to deliver for them. This is evidenced by the helicopter visions emanating from changed hunting laws which in turn change the way Bhils view the state and society around them. While Bhils come to terms with or question these laws in India, the irony is that the hunting of the very species which stands declared as under threat stands hunted clandestinely on ground by all kinds of actors, despite a ‘jail without bail’ provision that presumably should up the ante for criminal activities such as poaching. In this context this paper talks of the world view of the Bhils over the issue in general, their dilemmas and emic perspectives in particular. It also brings to light the implications of conservation politics by other communities in the vicinity such as the Bishnois who wage collective struggles to ensure protection of endangered species, while the state remains distant and lags behind in its approach to answer the issues raised by the Bhils, newer market strategies and products gain a quick entry as well as growing relevance in the Bhil lifestyles.

Inspiratory Muscle Training Improves Intercostal and Forearm Muscle Oxygenation in Patients With Chronic Heart Failure: Evidence of the Origin of the Respiratory Metaboreflex

BackgroundThe impact of inspiratory muscle training (IMT) on respiratory and peripheral muscle oxygenation and perfusion during inspiratory muscle fatigue in patients with chronic heart failure (HF) has not been established. Methods and ResultsTwenty-six patients with chronic HF were randomly assigned to either 8 weeks of IMT or a control group. Inspiratory fatigue was induced by means of a progressive inspiratory resistive loading protocol until there was an inability to sustain inspiratory pressure, when the inspiratory muscle metaboreflex should be activated. The main outcomes were intercostal and forearm muscle oxygen saturation and deoxygenation as measured by means of near-infrared spectroscopy (NIRS) and blood lactate levels. Inspiratory muscle strength was increased by 78% (P < .001) after 8 weeks of participation in the IMT group. IMT attenuated the reduction of oxygen saturation in intercostal and forearm muscles and the increase in blood lactate during respiratory fatigue (P < .001 and P < .05, respectively). These changes were different from the control group (P < .01, P < .05, and P < .05, respectively). After 8 weeks, similar increases in oxygen consumption, mean arterial pressure, heart rate, stroke volume, and cardiac output were observed in both groups during respiratory fatigue. ConclusionsThis randomized controlled clinical trial demonstrates that IMT attenuates the respiratory muscle oxygen demand-delivery mismatch during respiratory fatigue in patients with chronic HF.

Relationship Between Affective Responses And Adherence To High Intensity Interval Training In Obese African-American Women

INTRODUCTION: A previous parent study showed significantly better adherence for high intensity interval training (HIIT; 31% dropout) compared to steady state (SS; 73% dropout) in a sample of inactive, obese African-American (AA) women (N=27; age: 30.5±6.8 yrs; 5274±1646 steps/day; BMI: 35.1±5.1 kg/m2). However, the relationship between affective responses and adherence is unclear. PURPOSE: To conduct exploratory and descriptive analyses of affective responses over time between SS vs. HIIT conditions, and between study completers vs. non-completers. METHODS: Subjects were randomized into a 16-week treadmill exercise intervention, consisting of 4 weeks of conditioning, then 12 weeks of SS or HIIT training. The intervention consisted of three, 32-min bouts/week. SS bouts consisted of continuous exercise at 60-70% of maximal heart rate (HRmax). The time-matched HIIT bouts alternated 3-min lower-intensity intervals (60-70% HRmax) with 1-min high-intensity intervals (80-90% of HRmax). Core affect was assessed using the Feeling Scale (FS), pre- and post-exercise, as well as after the 8th, 20th, and 32nd minute of exercise. Possible FS scores range from -5 (very bad) to 5 (very good). Mean in-task FS scores are reported for the average of three sessions of week 5 and the last week of participation. Descriptive and frequency analyses are presented over the entire week. RESULTS: SS completers reported FS values of 5.00±0.00 both at week 5 and week 16. HIIT completers reported mean in-task FS values of 2.88±1.19 at week 5 and 3.82±0.63 at week 16. At week 5, SS and HIIT non-completers reported FS values of and 4.08±0.86 and 2.91±1.77, respectively. During the final week of participation (8.7±3.3 wks), SS and HIIT non-completers reported FS values of 3.88±1.13 and 3.16±1.18, respectively. Of 221 SS and 586 HIIT bouts completed, 11 (5.0%) and 42 (7.2%) contained ≥ one negative in-task FS score, respectively. CONCLUSION: While HIIT subjects consistently reported lower FS values relative to SS subjects, mean values were positive and similar to those observed for SS exercise in prior studies. Further, despite lower FS values, HIIT subjects had less dropout. Thus, it seems that HIIT is feasible in this population. These pilot data suggest the need for further research on contributors to adherence to HIIT in low-active, obese AA women.