Between-group Differences In Favour Research Articles

Specific Neurodynamic Exercises on Pain and Disability in Old Women with Chronic Mechanical Neck Pain: A Randomized Controlled Trial.

Neurodynamic exercise is a specific type of exercise used as a neural treatment that focuses on restoring altered homeostasis in the neuroimmune system by mobilising the nervous system and other structures. A prospective, randomized clinical trial was performed to evaluate the effect of neurodynamic exercises on disability and neck pain in elderly women over four weeks. Participants were randomized into two groups: a neurodynamic (NM) group (n = 28) and a non-specific exercise (NSE) group (n = 28). Inclusion criteria were women over 65 years of age who subjectively admitted to having mechanical neck pain for more than six months. Results showed that specific neurodynamic exercises can improve pain and disability in older women with chronic mechanical neck pain. Improvements were observed in all variables (p < 0.05). Significant between-group differences in favour of the NM group were only found for neck pressure pain thresholds and both tibialis anterior muscles. Larger effect sizes were obtained in favour of the NM group, especially for pain, disability, neck extension and inclination and pressure pain thresholds. Neurodynamic exercises have been shown to be more clinically relevant in disability and neck pain in older women.

Effects of inpatient energy management education and high-intensity interval training on health-related quality of life in persons with multiple sclerosis: A randomized controlled superiority trial with six-month follow-up.

Fatigue is one of the most frequent symptoms in persons with multiple sclerosis (pwMS) and impacts health-related quality of life (HRQoL). A multidisciplinary rehabilitation approach is recommended for the treatment of fatigue in pwMS. However, high-quality evidence exists only for unimodal interventions, such as physical therapies/exercise or energy/fatigue management programmes. The primary objective of the current study was to test the hypothesis that a combination of inpatient energy management education (IEME) and high-intensity interval training (HIIT) is superior to a combination of progressive muscle relaxation (PMR) and moderate continuous training (MCT) for improving HRQoL at 6-month follow-up in fatigued pwMS. A randomized (1:1) controlled superiority trial with fatigued pwMS >18 years of age, with Expanded Disability Status Scale (EDSS) score ≤6.5, recruited at the Valens clinic, Switzerland. Participants in the experimental group performed IEME twice and HIIT 3 times per week and those in the usual care group performed PMR twice and MCT 3 times per week, during a 3-week inpatient rehabilitation stay. Primary outcome was HRQoL (Physical and Mental Component Scales of the Medical Outcome Study 36-item Short Form Health Survey (SF-36)), assessed at entry to the clinic (T0), after 3 weeks' rehabilitation (T1) and 4 (T2) and 6 (T3) months after T0. Secondary outcomes included SF-36 subscales, fatigue (Fatigue Scale for Motor and Cognitive Functions (FSMC)), mood (Hospital Anxiety and Depression Scale (HADS)), self-efficacy for performing energy conservation strategies (Self-Efficacy for Performing Energy Conservation Strategies Assessment (SEPECSA)), self-perceived competence in activities of daily living (Occupational Self Assessment (OSA)) and cardiorespiratory fitness (peak oxygen consumption (VȮ2peak)). Data were analysed using a mixed model for repeated measures approach. A total of 106 pwMS (age (years): 49.75 (9.87), 66% female, EDSS: 4.64 (1.32)) were recruited. There were no significant group×time interaction effects in the primary and secondary outcomes. There were significant between-group differences in the pairwise comparisons of the group×time interaction in favour of the IEME+HIIT group at: (i) T1 in cardiorespiratory fitness (p=0.011) and SEPECSA (p=0.032); (ii) T2 in SF-36 mental health subscale (p=0.022), HADS anxiety subscale (p=0.014) and SEPECSA (p=0.040); (iii) T3 in SF-36 physical functioning subscale (p=0.012) and SEPECSA (p=0.003). IEME+HIIT was not superior to PMR+MCT regarding the effects on HRQoL (SF-36 Physical and Mental Component Scales) at 6-month follow-up in pwMS. However, there were significant between-group differences in favour of IEME+HIIT in physical functioning and mental health (SF-36 subscales), anxiety (HADS), cardiorespiratory fitness (VȮ2peak) and self-efficacy (SEPECSA) at different measurement time-points that need to be considered in clinical practice.

Long-term effectiveness of a cognitive behavioural therapy (CBT) in the management of fatigue in patients with relapsing remitting multiple sclerosis (RRMS): a multicentre, randomised, open-label, controlled trial versus standard care

BackgroundFatigue is a disabling symptom of multiple sclerosis (MS). The lack of effective therapeutics has promoted the development of cognitive behavioural therapy (CBT)-based fatigue management programmes. However, their efficacy does...

The Health Effects of 14 Weeks of Physical Activity in a Real-Life Setting for Adults with Intellectual Disabilities.

The life expectancy of individuals with intellectual disabilities (ID) is reduced compared to the general population, and one of the main contributors to earlier death is inactivity. To investigate how 14 weeks of physical activity (PA) in a real-life setting affects cardiovascular fitness, body composition and bone health of adults with ID. Adults with ID were recruited into a PA-group (N = 52) or a control group (CON, N = 14). The PA-group participated in 14 weeks of PA, and body composition, cardiovascular fitness and bone health were assessed before and after the intervention. Outcomes and Results. Cardiovascular fitness and body composition improved from pre to post within the PA-group: Heart rates (HR) during the last 30 seconds of two increments of a treadmill test, were reduced (3.2 km/h: -4.4 bpm, p < 0.05; 4.8 km/h: -7.5 bpm, p < 0.001) and fat mass was reduced (-1.02 kg, p < 0.05). A between-group difference in favour of the PA-group, were observed in whole body bone mineral density (BMD) (0.024 g/cm2, p < 0.05). Conclusions and Implications. Fourteen weeks of PA performed in a real-life setting increased cardiovascular fitness, reduced fat mass and improved BMD in the weight-bearing skeleton in the PA-group. Increased and regular PA seems to be a promising tool to promote physical health in adults with ID.

Pain self-management intervention supports successful attainment of self-selected rehabilitation goals-secondary analysis of a randomized controlled trial.

Objectives(i) Describe patients' self‐selected activity‐related rehabilitation goals, and (ii) compare attainment of these rehabilitation goals among people with persistent tension‐type neck pain receiving a group‐based pain and stress self‐management intervention (PASS) or individual physiotherapy (IPT).MethodsBefore intervention and random allocation to PASS or IPT, 156 people (PASS n = 77, IPT n = 79), listed three self‐selected activity‐related rehabilitation goals by use of the Patient Goal Priority Questionnaire (PGPQ). For each activity goal, participants rated limitations in activity performance, self‐efficacy and fear of activity performance, readiness to change to improve performance, and expectations of future activity performance. At follow‐ups (10 weeks, 20 weeks, 1 year and 2 years after inclusion), participants also responded to a question on changes made to improve activity performance. Mann–Whitney U test was used to evaluate between‐group differences.ResultsThere were between‐group differences in favour of PASS in the attainment of self‐selected rehabilitation goals with regard to activity limitations and satisfaction with activity performance at all follow‐ups.ConclusionsPASS was more successful than IPT for the attainment of self‐selected rehabilitation goals, improvements in activity limitations and satisfaction with activity performance as measured by PGPQ. The PASS programme emphasized the importance of applying active pain‐ and stress‐coping techniques in personal ‘risk situations’ for pain flare‐ups, which appear to support people with persistent tension‐type neck pain to make changes in their lives to improve activity performance.Patient or Public ContributionPatient engagement in rehabilitation by self‐selected goals was investigated, but patients were not involved in the design or conduct of the study.

The effect of sensory discrimination training on sensorimotor performance in individuals with central neurological conditions: A systematic review

Objective The aim of this systematic review was to investigate the efficacy of sensory discrimination training (SDT) on sensorimotor performance in individuals with a neurological condition affecting the central nervous system. Methods MEDLINE, CINAHL, EMBASE, AMED, CENTRAL, PsychINFO, Scopus, OT Seeker, PEDro, ETHOS, Web of Science and OpenGrey were systematically searched for appropriate randomised controlled trials (RCTs). Included studies were assessed for risk of bias, and the quality of the evidence was rated using the GRADE approach. The protocol was registered on PROSPERO (CRD42017055237). Results Six RCTs met the inclusion/exclusion criteria. All studies used manual tactile discrimination to retrain somatosensation. Somatosensory effect sizes (0.12–0.92) and motor function effect sizes (0.12–10.39) ranged from trivial to large with narrative analysis revealing some between-group difference in favour of the intervention group. However, the total sample size ( n = 220) was relatively small, and the quality of the included studies was low. Conclusions SDT may have potential to be an efficacious treatment option for improving sensorimotor performance in individuals with neurological disease. However, at present there is limited evidence on which to base any firm clinical recommendations.

Shoe-stiffening inserts for first metatarsophalangeal joint osteoarthritis: a randomised trial

To evaluate the efficacy of carbon-fibre shoe-stiffening inserts in individuals with first metatarsophalangeal joint osteoarthritis. This was a randomised, sham-controlled, participant- and assessor-blinded trial. One hundred participants with first metatarsophalangeal joint osteoarthritis received rehabilitation therapy and were randomised to receive either carbon fibre shoe-stiffening inserts (n=49) or sham inserts (n=51). The primary outcome measure was the Foot Health Status Questionnaire (FHSQ) pain domain assessed at 12 weeks. All 100 randomised participants (mean age 57.5 (SD 10.3) years; 55 (55%) women) were included in the analysis of the primary outcome. At the 12 week primary endpoint, there were 13 drop-outs (7 in the sham insert group and 6 in the shoe-stiffening insert group), giving completion rates of 86 and 88%, respectively. Both groups demonstrated improvements in the FHSQ pain domain score at each follow-up period, and there was a significant between-group difference in favour of the shoe-stiffening insert group (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, P=0.030). There were no between-group differences for the secondary outcomes, although global improvement was more common in the shoe-stiffening insert group compared to the sham insert group (61 vs 34%, RR 1.73, 95% CI 1.05 to 2.88, P=0.033; number needed to treat 4, 95% CI 2 to 16). Carbon-fibre shoe-stiffening inserts were more effective at reducing foot pain than sham inserts at 12 weeks. These results support the use of shoe-stiffening inserts for the management of this condition, although due to the uncertainty around the effect on the primary outcome, some individuals may not experience a clinically worthwhile improvement.

Feasibility and estimated efficacy of blood flow restricted training in female patients with rheumatoid arthritis: a randomized controlled pilot study

Objectives: The study aimed to evaluate the feasibility of a blood flow restriction (BFR) training regimen in patients with rheumatoid arthritis (RA); and to compare the effects of 4 weeks of BFR training with low-intensity strength training on muscle strength, muscle endurance, and joint pain in patients with RA. Method: In this non-blinded pilot randomized controlled trial, 18 women with RA aged 18–65 years performed low-intensity strength training for the lower limbs three times a week for 4 weeks, and were randomized to train with or without occlusion bands. The primary outcomes were registration of the recruitment process, compliance with training sessions, side effects, perceived pain, and a satisfaction survey. The secondary outcomes were changes in muscle strength, muscle endurance, and joint pain. Results: The findings of this pilot study included a challenging recruitment process, well tolerated training and test protocols, overall good patient satisfaction, no serious side effects, and high compliance. Both groups achieved significant improvements in knee extensor strength from baseline to follow-up, with a change of 11.5 kg [interquartile range (IQR) 9.8;13.0] in the intervention group and 8.4 kg (IQR 5.5;12.4) in the control group, and a significant between-group difference in favour of the intervention group (p = 0.0342). Conclusions: The feasibility results of this study indicated a challenging recruitment process, general satisfaction with the BFR and exercises, good compliance, and only expected non-serious side effects. BFR training may improve knee extensor strength in women with RA, compared low-intensity strength training without BFR.

Efficacy of heel lifts versus calf muscle eccentric exercise for mid-portion Achilles tendinopathy (HEALTHY): a randomised trial

Objective(s)To compare the efficacy of in-shoe heel lifts to calf muscle eccentric exercise in reducing pain and improving function in mid-portion Achilles tendinopathy.MethodsThis was a parallel-group randomised superiority trial at...

Effects of a resistance and balance exercise programme on physical fitness, health-related quality of life and fear of falling in older women with osteoporosis and vertebral fracture: a randomized controlled trial.

Guidelines for exercise strongly recommend that older adults with osteoporosis or osteoporotic vertebral fracture should engage in a multicomponent exercise programme that includes resistance training in combination with balance training. Prior research is scarce and shows inconsistent findings. This study examines whether current exercise guidelines for osteoporosis, when applied to individuals with vertebral fractures, can improve health outcomes. This single blinded randomized controlled trial included 149 older women diagnosed with osteoporosis and vertebral fracture, 65+ years. The intervention group performed a 12-week multicomponent exercise programme, the control group received usual care. Primary outcome was habitual walking speed, secondary outcomes were physical fitness (Senior Fitness Test, Functional Reach and Four Square Step Test), health-related quality of life and fear of falling. Descriptive data was reported as mean (standard deviation) and count (percent). Data were analyzed following intention to treat principle and per protocol. Between-group differences were assessed using linear regression models (ANCOVA analysis). No statistically significant difference between the groups were found on the primary outcome, walking speed (mean difference 0.04m/s, 95% CI - 0.01-0.09, p = 0.132). Statistically significant between-group differences in favour of intervention were found on FSST (dynamic balance) (mean difference - 0.80s, 95% CI - 1.57 to - 0.02, p = 0.044), arm curl (mean difference 1.55, 95% CI 0.49-2.61, p = 0.005) and 30-s STS (mean difference 1.85, 95% CI 1.04-2.67, p < 0.001), as well as fear of falling (mean difference - 1.45, 95% CI - 2.64 to - 0.26, p = 0.018). No statistically significant differences between the groups were found on health-related quality of life. Twelve weeks of a supervised multicomponent resistance and balance exercise programme improves muscle strength and balance and reduces fear of falling, in women with osteoporosis and a history of vertebral fractures. ClincialTrials.gov Identifier: NCT02781974. Registered 25.05.16. Retrospectively registered.

Effectiveness of Interventions and Behaviour Change Techniques for Improving Dietary Intake in Young Adults: A Systematic Review and Meta-Analysis of RCTs.

Poor eating habits are common during young adulthood and influence chronic disease morbidity. This systematic review evaluates the effectiveness of interventions aiming to improve dietary intake among young adults and, identifies which behaviour change techniques (BCTs) are most effective. Six electronic databases were searched for RCTs published until October 2018, and evaluating behavioural interventions assessing change in dietary intake in young adults (17–35 years). Of the 18,779 articles identified, 54 were included. Forty studies focused on fruit and/or vegetable intake, of which 63% showed a significant between-group difference in favour of the intervention group. Meta-analysis (n = 17) demonstrated a significant increase in fruit and vegetable intake of +68.6 g/day after three months of intervention and +65.8 g/day for interventions >3 months when compared to control. A meta-analysis (n = 5) on total energy intake found no significant differences between groups. The BCTs with the highest effectiveness ratio were habit formation (100%), salience of consequences (83%) and adding objects to the environment (70%). The review highlights the potential of behavioural interventions to improve young adults’ fruit and vegetable intake but was less convincing for other dietary outcomes. Due to the lack of studies including each BCT, the BCTs imperative to success could not be identified.

Effects and feasibility of virtual reality system vs traditional physical therapy training in multiple sclerosis patients

Background/Aims: Traditionally, physical therapy for gait and balance training takes place in a gym setting, which may not fully reproduce situations in everyday activities. The Computer Assisted Rehabilitation ENvironment system provides an immersive virtual environment, allowing a simulation of complex conditions conducive to gait and balance training. The purpose of this study was to determine: (1) the feasibility and safety of using the Computer Assisted Rehabilitation ENvironment system for physical therapy sessions with multiple sclerosis patients, and (2) pre-post treatment changes observed with the Computer Assisted Rehabilitation ENvironment system compared to traditional physical therapy. Findings: Data from functional outcome measures Berg Balance Scale, Timed Up and Go test, Timed 25-Foot Walk, and 6-Minute Walk Test were extracted from the medical records of 62 patients with multiple sclerosis who had at least three physical therapy sessions in either environment. Statistically significant within-group improvements were observed for all outcome measures in the physical therapy Computer Assisted Rehabilitation ENvironment system group (P&lt;0.05), and only for Berg Balance Scale in the traditional physical therapy group. There was a significant between-group difference in favour of physical therapy with the Computer Assisted Rehabilitation ENvironment system for the Timed 25-Foot Walk (P=0.022). Conclusions: The results suggest the Computer Assisted Rehabilitation ENvironment system is a safe and effective tool for physical therapy-led gait and balance training for individuals with multiple sclerosis.

Long-term effect of exercise training in patients after transcatheter aortic valve implantation: Follow-up of the SPORT:TAVI randomised pilot study.

Background Increased exercise capacity favourably influences clinical outcomes after transcatheter aortic valve implantation. In our SPORT:TAVI randomised pilot trial, eight weeks of endurance and resistance training (training group, TG) shortly after transcatheter aortic valve implantation resulted in significantly improved exercise capacity, muscular strength and quality of life compared to usual care (UC). However, the long-term clinical benefits of such an intervention are unknown. Design A randomised controlled trial. Methods SPORT:TAVI participants underwent reassessment of trial endpoints 24 ± 6 months after baseline: maximal oxygen uptake (VO2peak) and anaerobic threshold (VO2AT) were assessed with cardiopulmonary exercise testing, muscular strength with one-repetition maximum testing, quality of life with the Kansas City cardiomyopathy and medical outcomes study 12-item short-form health survey questionnaires, and prosthetic aortic valve function with echocardiography. Results Of 27 original participants (TG 13; UC 14; age 81 ± 6 years), more patients had died during follow-up in UC ( n = 5) than in TG ( n = 2; P = 0.165); three further patients (TG 1; UC 2) were unavailable for other reasons. In the remaining patients (TG 10; UC 7), a significant between-group difference in favour of TG was observed for change in VO2AT from baseline (2.7 ml/min/kg (95% confidence interval 0.8-4.6); P = 0.008), but not for change in VO2peak (2.1 ml/min/kg (-1.1-5.4); P = 0.178). Changes in muscular strength and quality of life did not differ between groups over time. Overall, prosthetic valve function remained intact in both groups. Conclusions Eight weeks of exercise training shortly after transcatheter aortic valve implantation resulted in preserved long-term improvements in VO2AT, but not VO2peak, muscular strength or quality of life compared to usual care. The findings emphasise the importance of ongoing exercise interventions following transcatheter aortic valve implantation to maintain initial improvements long term. Clinical Trial Registration (original trial): Clinicaltrials.gov NCT01935297.

Medical treatment or surgery for colorectal endometriosis? Results of a shared decision-making approach.

What is the degree of patient satisfaction in women with symptomatic colorectal endometriosis who choose medical or surgical treatment after a shared decision-making (SDM) process? The degree of satisfaction with treatment was high both in women who chose medical treatment with a low-dose oral contraceptive (OCP) or a progestin, and in those who chose to undergo surgical resection of bowel endometriosis. Hormonal therapies and surgery for colorectal endometriosis have been investigated in non-comparative studies with inconsistent results. Parallel cohort study conducted on 87 women referring to our centre with an indication to surgery for colorectal endometriosis. A standardised SDM process was adopted, allowing women to choose their preferred treatment. Median follow-up was 40 [18-60] months in the medical therapy group and 45 [30-67] in the surgery group. Patients with endometriosis infiltrating the proximal rectum, the rectosigmoid junction, and the sigmoid, not causing severe sub-occlusive symptoms were enroled. A total of 50 patients chose treatment with an OCP (n = 12) or a progestin (n = 38), whereas 37 women confirmed their previous indication to surgery. Patient satisfaction was graded according to a 5-category scale. Variations in bowel and pain symptoms were measured by means of a 0-10 numeric rating scale. Constipation was assessed with the Knowles-Eccersley-Scott Symptom Questionnaire (KESS), health-related quality of life with the Short Form-12 questionnaire (SF-12), psychological status with the Hospital Anxiety and Depression scale (HADS) and sexual functioning with the Female Sexual Function Index (FSFI). Six women in the medical therapy group requested surgery because of drug inefficacy (n = 3) or intolerance (n = 3). Seven major complications were observed in the surgery group (19%). At 12-month follow-up, 39 (78%) women in the medical therapy group were satisfied with their treatment, compared with 28 (76%) in the surgery group (adjusted odds ratio (OR), 1.37; 95% confidence interval (CI), 0.45-4.15; intention-to-treat analysis). Corresponding figures at final follow-up assessment were 72% in the former group and 65% in the latter one (adjusted OR, 1.74; 95% CI, 0.62-4.85). The 60-month cumulative proportion of dissatisfaction-free participants was 71% in the medical therapy group compared with 61% in the surgery group (P = 0.61); the Hazard incidence rate ratio was 1.21 (95% CI, 0.57-2.62). Intestinal complaints were ameliorated by both treatments. Significant between-group differences in favour of medical treatment were observed at 12-month follow-up in diarrhoea, dysmenorrhoea, non-menstrual pelvic pain and SF-12 physical component scores. The total HADS score improved significantly in both groups, whereas the total FSFI score improved only in women who chose medical therapy. As treatments were not randomly assigned, selection bias and confounding are likely. The small sample size exposes to the risk of type II errors. When adequately informed and empowered through a SDM process, most patients with non-occlusive colorectal endometriosis who had already received a surgical indication, preferred medical therapy. The possibility of choosing the preferred treatment may allow maximisation of the potential effect of the interventions. This study was financed by Italian fiscal contribution '5 × 1000'-Ministero dell'Istruzione, dell'Università e della Ricerca-devolved to Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy. P.V., M.P.F., R.R., D.D., A.R., P.M., O.D.G. and M.C. declare that they have no conflicts of interest. E.S. received grants from Ferring and Serono.

Does the addition of two exercise-focussed home visits to usual care improve outcomes for patients with balance impairments? A randomized controlled trial

Objective: To investigate whether two additional home visits improve outcomes for rehabilitation outpatients with balance impairments compared to usual care. Design: Randomized controlled trial. Setting: Outpatient rehabilitation. Participants: Fifty with balance impairments. Interventions: Both groups received usual care including weekly group exercise over eight weeks. The intervention group received two home visits to individualize home exercises. Outcome measures: Primary outcome measure was the Balance Outcome Measure for Elder Rehabilitation (BOOMER) score, and secondary outcomes included force platform measures using the NeuroCom Balance Master®, assessed at baseline, after intervention and three-month follow-up. Results: There was no between-group difference for BOOMER score. There were significant between-group differences in favour of the intervention group for limits of stability reaction time at week 9 (mean difference (MD) −0.27, 95% confidence interval (CI) −0.44 to −0.09) and week 22 (MD −0.28, 95% CI −0.45 to −0.10) and for limits of stability maximal excursion at week 9 (MD 8.66, 95% CI 1.67 to 15.65) and week 22 (MD 14.58, 95% CI 7.59 to 21.57). Significant between-group differences favoured the control group for Clinical Test of Sensory Interaction of Balance at week 9 (MD 0.40, 95% CI 0.13 to 0.66) and week 22 (MD 0.45, 95% CI 0.18 to 0.72) and step quick turn time at week 9 (MD 0.56, 95% CI 0.02 to 1.10). Conclusion: Two exercise-focussed home visits improved some dynamic balance outcomes in older patients with balance impairments. Some outcomes showed significant improvements with small effect sizes in favour of the control group which may be chance findings or because they completed a standard home exercise programme.

TREATMENT OF SEVERE AGITATION IN NURSING HOMES WITH THE TIME MODEL: RESULTS FROM A CLUSTER-RANDOMIZED CONTROLLED TRIAL

A number of clinical trials on caregiver-oriented interventions to treat neuropsychiatric symptoms in dementia has been performed, but the results are contradictory. In a three-month cluster randomized trial including 229 nursing home patients with dementia and moderate to high levels of agitation the participants received either the Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric symptoms (TIME) or a brief education-only intervention. Outcomes were assessed at baseline, eight and twelve weeks. The primary endpoint was between-group difference in change on the agitation item of the Neuropsychiatric Inventory Nursing-home version (NPI-NH) at 8 weeks. Secondary outcomes were between-group differences on agitation at twelve weeks and between-group differences on other neuropsychiatric symptoms, quality of life and use of psychotropic and analgesic drugs. Two-hundred and two patients (88.2%) completed the study. A significant between-group difference was found at both 8 weeks and 12 weeks in favour of patients receiving the TIME intervention. Of the secondary outcomes delusion, depression, disinhibition and quality of life showed significant between-group difference in favour of those receiving the TIME intervention. Among nursing-home patients with dementia and moderate to severe agitation the TIME intervention was superior to an education-only intervention. The results add to the increasing evidence base for the efficacy of non-pharmacological interventions in treating agitation in dementia.

Positive effects on bone mineralisation and muscular fitness after 10 months of intense school-based physical training for children aged 8–10 years: the FIT FIRST randomised controlled trial

ObjectivesWe investigated whether musculoskeletal fitness of school children aged 8–10 years was affected by frequent intense PE sessions.Design and participants295 Danish school children aged 8–10 years were cluster randomised to...

Optimizing diabetes control in people with Type 2 diabetes through nurse-led telecoaching.

To study the effect of a target-driven telecoaching intervention on HbA1c and other modifiable risk factors in people with Type 2 diabetes. We conducted a randomized controlled trial in patients receiving hypoglycaemic agents. The primary outcome was HbA1c level at 6 months in the entire sample and in a subgroup with HbA1c levels ≥ 53 mmol/mol (7%) at baseline. Secondary outcomes were HbA1c at 18 months; total cholesterol, LDL, HDL, triglycerides, blood pressure, BMI and proportion of people who had achieved guideline-recommended targets at 6 and 18 months. A total of 287 participants were randomized to telecoaching and 287 to usual care. The mean (sd) baseline HbA1c level was 53 (11) mmol/mol [7.0 (1.0)%] overall and 63 (10) mmol/mol [7.9 (0.9)%] in the elevated HbA1c subgroup. At 6 months, the between-group differences in favour of telecoaching were: HbA1c -2 (95% CI -4; -1) mmol/mol [-0.2 (95% CI -0.3;-0.1)%; P=0.003] overall and -4 (95% CI -7; -2) mmol/mol [-0.4 (95% CI -0.7; -0.2)%; P=0.001] in the elevated HbA1c subgroup; BMI -0.4 kg/m(2) (95% CI -0.6; -0.1; P=0.003); total cholesterol -6 mg/dl (95% CI -11; -1, P=0.012). The proportion of participants on target for the composite of HbA1c , LDL and blood pressure increased by 8.9% in the intervention group and decreased by 1.3% in the control group (P=0.011). At 18 months, the difference in HbA1c was: -2 (95% CI -3;-0) mmol/mol [-0.2 (95% CI -0.3; -0.0)%; P=0.046] overall and -4 (-7; -1) mmol/mol [-0.4 (95% CI -0.7; -0.1)%; P=0.023] in the elevated HbA1c subgroup. Nurse-led telecoaching improved glycaemic control, total cholesterol levels and BMI in people with Type 2 diabetes. Twelve months after the intervention completion, there were sustained improvements in glycaemic control.

Football training in men with prostate cancer undergoing androgen deprivation therapy: activity profile and short-term skeletal and postural balance adaptations.

To investigate the activity profile of football training and its short-term effects on bone mass, bone turnover markers (BTMs) and postural balance in men with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT). This was a randomised 12-week study in which men with PCa undergoing ADT were assigned to a football intervention group [FTG, n = 29, 67 ± 7 (±SD) years] training 2‒3 times per week for 45‒60 min or to a control group (n = 28, 66 ± 5 years). The activity profile was measured using a 5-Hz GPS. The outcomes were total body and leg bone mineral content (BMC) and density, BTMs and postural balance. In the last part of the 12 weeks, FTG performed 194 ± 41 accelerations and 296 ± 65 decelerations at >0.6 m/s/s and covered a distance of 905 ± 297 m at speeds >6 km/h and 2646 ± 705 m per training session. Analysis of baseline-to-12-week change scores showed between-group differences in favour of FTG in total body BMC [26.4 g, 95 % confidence interval (CI): 5.8-46.9 g, p = 0.013], leg BMC (13.8 g, 95 % CI: 7.0‒20.5 g, p < 0.001) and markers of bone formation: P1NP (36.6 µg/L, 95 % CI: 10.4‒62.8 µg/L, p = 0.008) and osteocalcin (8.6 µg/L, 95 % CI: 3.3‒13.8 µg/L, p < 0.01). The number of decelerations correlated to the increase in leg BMC (r = 0.65, p = 0.012). No between-group differences were observed for the remaining outcomes. Football training involves numerous runs, accelerations and decelerations, which may be linked to marked increases in bone formation markers and preserved bone mass in middle-aged and elderly men with PCa undergoing ADT. ClinicalTrials.gov: NCT01711892.

Are Group Psychotherapeutic Treatments Effective for Patients with Schizophrenia? A Systematic Review and Meta-Analysis

Background: Different psychotherapeutic treatments for schizophrenia are delivered in groups. However, little is known about the effectiveness of these group therapies for people with schizophrenia across different treatments with varying therapeutic orientations. This review aimed to (1) estimate the effect of different group psychotherapeutic treatments for schizophrenia and (2) explore whether any overall ‘group effect' is moderated by treatment intensity, diagnostic homogeneity and therapeutic orientation. Methods: A systematic search of randomised controlled trials exploring the effectiveness of group psychotherapeutic treatments for people with schizophrenia was conducted. Random-effect meta-analyses on endpoint symptom scores compared group psychotherapeutic treatments with treatment as usual and active sham groups. Findings on social functioning were described narratively, and meta-regression analyses on group characteristics were carried out. Results: Thirty-four eligible trials were included. A weak-to-moderate significant between-group difference in favour of group psychotherapeutic treatments was found for negative symptom scores (standard mean difference = -0.37, 95% confidence interval -0.60, -0.14; p < 0.01, I² = 59.8%) only when compared to treatment as usual and not to active sham groups. Improved social functioning was reported as a treatment outcome in the majority of studies compared to treatment as usual. The ‘group effect' on negative symptoms was positively related to ‘treatment intensity' (β = 0.32, standard error = 0.121; p < 0.05). Conclusion: Group psychotherapeutic treatments can improve negative symptoms and social functioning deficits in the treatment of schizophrenia. The effect occurs across different treatments and appears to be non-specific. Future research should identify the underlying mechanisms for the positive effect of participating in groups and explore how they can be maximised to increase the therapeutic benefit.