Change In Walk Distance Research Articles

Tricuspid transcatheter edge-to-edge repair for severe tricuspid regurgitation: 1-year outcomes from the TRILUMINATE randomized cohort.

Tricuspid regurgitation (TR) is a right-sided valvular disease independently associated with morbidity and mortality. The TRILUMINATE Pivotal trial is the first randomized, controlled trial assessing the impact of TR reduction with tricuspid transcatheter edge-to-edge repair (T-TEER). Outcomes from the full randomized cohort of the TRILUMINATE Pivotal trial have not been previously reported, and the additional enrollment may further support the safety and effectiveness of T-TEER through 1 year. The TRILUMINATE Pivotal trial is an international RCT of T-TEER with the TriClip device in patients with symptomatic, severe TR. Adaptive trial design allowed enrollment past the primary analysis population. The primary outcome was a hierarchical composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations (HFH), and quality-of-life improvement measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 1 year. Between August 21, 2019 and June 29, 2022, 572 subjects were randomized, including the primary cohort (n=350) and subsequent enrollment (n=222). Subjects were elderly (78.1±7.8 years) and predominantly female (58.9%), with atrial fibrillation (87.8%) and prior HFH (23.8%). The primary endpoint was met for the full cohort (win ratio=1.84, p<0.0001). Freedom from all-cause mortality and tricuspid valve surgery through 12 months was 90.6% and 89.9% for the device and control groups, respectively (p=0.82). Annualized HFH rate was comparable between device and control subjects (0.17 vs 0.20 events/patient-year, p=0.40). A significant treatment effect was observed for change in quality of life with 49.5% of device subjects achieving a ≥15-point KCCQ score improvement (compared to 25.6% of control subjects, p<0.0001). All secondary endpoints favored T-TEER: moderate or less TR at 30 days (88.9% vs 5.3%, p<0.0001), KCCQ change at 1 year (13.0±1.4 vs -0.5±1.4 points, p<0.0001), and six-minute walk distance change at 1 year (1.7±7.5 vs -27.4±7.4 meters, p<0.0001). Freedom from major adverse events was 98.9% for T-TEER (vs. performance goal: 90%, p<0.0001). TriClip was safe and effective in the full randomized cohort of TRILUMINATE Pivotal with significant TR reduction and improvements in six-minute walk distance and health status. Rates of all-cause mortality or TV surgery and HFH through 1 year were not reduced by T-TEER.

PSIII-4 Exploring the behavioral effects of glycerol supplementation in ruminally cannulated cows grazing wheat pasture

Abstract Energy intake and metabolism have a key role in the control of dry matter intake (DMI), fermentation processes, and grazing behavior of beef cattle, and is likely affected by intertwined relationships between forage availability and stage of maturity, offering of energy supplements and climate- and animal-related factors. Ruminally cannulated mixed-breed nonlactating cows [n = 9; initial body weight (BW) = 564.4 ± 101.6 kg] grazing wheat pasture were used in a split-plot design with the objectives of evaluating the effects crude glycerine supplementation and forage maturity on grazing behavior. Treatment was the main plot, and stage of forage maturity was the subplot. Treatments were unsupplemented control (CON) and crude glycerine supplementation (SUP). Crude glycerol (37.2% glycerol, DM basis) was offered at 0.11% of BW (DM basis) and dosed intraruminally via rumen cannula at 0700 and 1900 h daily. The stages of wheat pasture maturity were March (MAR; vegetative stage) and April (APR; early reproductive stage). All cows were fitted with LoRa WAN tracking collars, housing GPS and triaxial accelerometers and allowing real-time inspection of cow position and activity data through time. Hourly (d 10 and 23) and daily change of walking distance (m), activity index and budget for grazing, resting, and walking time (min) were analyzed with a repeated measure mixed model for the split-plot design. Walking distance (1,200 ± 13 m), activity index (10,006 ± 122), resting time (607 ± 5 min), grazing time (662 ± 8 min) and walking time (171 ± 8 min) were not affected (P ≥ 0.52) by crude glycerine supplementation or by stage of forage maturity (P ≥ 0.07), but varied (P &amp;lt; 0.001) by day and by hour of day, likely indicating circadian effects on meal frequency and duration associated with the hour of the day and forage depletion through time. Grazing behavior was more likely affected by climate, pasture, animal, and management variables and less affected by GLY dose. Results indicate that crude glycerine may be used in supplements for cattle grazing wheat pasture to increase energy intake and without adversely creating associative or substitution effects, grazing behavior or sacrificing pasture utilization.

Early heart rate recovery after a 6-min walking test in patients after percutaneous aortic valve implantation coresponds with clinical benefits

Abstract Background Time-appropriate return to a resting heart rate (HR) after cessation of exercise is a marker for predicting outcomes in patients with heart failure (HF). We aimed to evaluate the prognostic value of HR recovery in functional improvement in patients with severe aortic stenosis after percutaneous aortic valve implantation (TAVI). Methods 6 min walk test (6MWT) was performed in 93 individuals before TAVI and in 3 months follow up. The change in walking distance was measured. We analyzed also the differences between baseline HR, HR at the end of the test, and HR at the 1st, 2nd and 3rd minute of recovery. Results After 3 months the distance of 6MWT in TAVI patients improved by 39±63 m and reached a total of 322±117 m. The differences between HR after 2 min of recovery and baseline HR in pre-TAVI after a 6MWT was the only significant predictor of waking distance improvement during follow-up in multiple linear regression model. Conclusions Our study showes that changes of HR recovery after a 6MWT may be a helpful and easy parameter to assess improvement in exercise capacity after TAVI. This simple method can also help to identify patients in whom no significant benefit in functional improvement can be expected despite successful valve implantation.Demographics

Ultra-short-period perioperative pulmonary rehabilitation on short-term outcomes after surgery in smoking patients with lung cancer: A randomized clinical trial.

Pulmonary rehabilitation is essential for airway management after thoracic surgery. Most current pulmonary rehabilitations are composed of 2-4-week exercises, which require significant consumption of medical resources and concerns about disease progression. This single-center, prospective, randomized controlled trial enrolled smoking patients with pulmonary masses or nodules suitable for lobectomy, aged 18-80, with smoking history (≥20 pack-years). Eligible patients were randomized in a 1:1 ratio into two groups. Patients in the intervention group underwent perioperative breathing exercises based on positive pressure vibration expectoration and three-day preoperative lower limb endurance training. Patients in the control group received routine perioperative care. The primary outcome was in-hospital incidence of postoperative pulmonary complications. Secondary outcomes included postoperative hospital stay, total hospitalization cost, postoperative drainage time, drainage volume, semiquantitative cough strength score, pain score, Borg scale-assessed fatigue, and walking distance on postoperative days 1 and 2. A total of 194 patients were included in the study with 94 in the intervention group and 100 in the control group. Our ultrashort pulmonary rehabilitation program potentially reduced pulmonary complications incidence (24.5% vs. 33.0%), but without statistical significance (P=0.190). No significant differences were found in other perioperative outcomes, except for postoperative semiquantitative cough strength score (3 [interquartile range, 3-3.75] vs. 3 [interquartile range, 2-3], P<0.001) and change in walking distance from postoperative days 1 to 2 (60 [interquartile range, 40-82.5] vs. 30 [interquartile range, 10-60], P=0.003). There were no significant differences in postoperative complications and other hospitalizations, but our ultrashort rehabilitation program improved patients' semiquantitative cough strength score and walking distance, indicating potential for better outcomes. This treatment is a safe and effective means of airway management for thoracic surgery in the era of enhanced recovery. (ClinicalTrials.gov Identifier: XXX).

Understanding what factors underpin change in walking distance in patients with depression following completion of cardiac rehabilitation: commentary.

Understanding what factors underpin change in walking distance in patients with depression following completion of cardiac rehabilitation: commentary.

Body Mass Index and Thoracic Expansion in Post-COVID Dyspnea: A Secondary Analysis.

Dyspnea secondary to lung impairment can persist following the acute phase of COVID-19. Thoracic expansion measurements have been used as a diagnostic tool to evaluate chest wall mobility, respiratory function, and the effects of respiratory muscle strength training. Changes in chest wall mobility may occur because of altered chest biomechanics in individuals with respiratory diseases and an elevated body mass index (BMI). The purpose of this secondary analysis was to evaluate whether BMI influences thoracic expansion or forced expiratory volume over 1 second (FEV1) in individuals with persistent dyspnea following COVID-19. This study assessed the relationship between BMI and thoracic expansion, pulmonary symptoms, and exercise capacity following a home-based pulmonary rehabilitation intervention. A secondary data analysis was conducted with a sample of 19 adults with persistent dyspnea following COVID-19 infection who participated in a 12-week, home-based pulmonary rehabilitation study. Participants received expiratory muscle strength training devices and were instructed to perform pulmonary rehabilitation exercises three times per week over the study period. Pulmonary function, pulmonary symptoms, exercise capacity, and BMI measurements were collected. For analysis, study participants were divided into obese (BMI > 30 kg/m2) or nonobese (BMI < 30 kg/m2) categories. Correlations using the change scores from baseline to 12 weeks between thoracic expansion, FEV1, pulmonary symptoms, and exercise capacity were assessed. In addition, the minimal detectable change (MDC) in thoracic expansion was explored. Thoracic expansion was significantly improved after 12 weeks of training (p = .012) in the nonobese group. There was a significant correlation between the change in walking distance and pulmonary symptoms (r = -.738, p < .001) and in thoracic expansion (r = .544, p = .020), and walking distance, when controlling for BMI, but no change in FEV1. Average MDC was 1.28 for inspiration and 0.91 for expiration. Measurements of thoracic expansion were significantly lower in post-COVID individuals with an increased BMI. Individuals with persistent dyspnea and a higher BMI may require additional measures to increase chest mobility or to detect pulmonary changes following COVID-19.

What are the determinants of change in walking fitness in patients with a history of depression following cardiac rehabilitation?

This study aims to investigate the demographic, clinical, and service-level factors determining change in walking fitness in cardiac rehabilitation (CR) patients with a history of depression following the CR programme. The National Audit of Cardiac Rehabilitation clinical data were used to identify 1476 patients with a history of depression who had their pre- and post-incremental shuttle walk test (ISWT) recorded between 1 January 2016 and 31 January 2020. A multiple linear regression was conducted to examine the determinants of change in walking fitness (m) following CR. Mean age was 61 (SD 10.45), and mean ISWT distance at baseline and outcome was 352.06 m (SD 169.48) and 463.43 m (SD 197.65), respectively. Multivariate analysis revealed that change in walking distance reduced by 1.6 m for each year increase in age at baseline (P < 0.001). Females and unemployed patients had less improvement in walking fitness (23.1 and 21.5 m, respectively). Having a body mass index (BMI) > 30 was associated with lower improvement (24.2 m, P < 0.001), while physically active patients had 14.6 m higher change. Higher baseline ISWT quintiles were associated with less improvement, and increased waiting time to start CR was associated with reduced change in walking fitness following CR. Older age, female gender, unemployment, higher baseline BMI, longer waiting time, and lower physical activity were associated with reduced walking fitness improvement in patients with a history of depression. Targeted intervention and prompt access to CR can optimize outcomes.

Effects of whole body vibration on functional capacity and respiratory functions in individuals with stroke: A randomized controlled study.

Management of respiratory-related functional problems using sensory rehabilitation strategies has been poorly researched in patients with stroke. This study aimed to investigate whether whole body vibration (WBV) training has an effect on functional capacity and respiratory functions in patients with stroke. In the randomized-controlled study, 28 participants were randomized into two groups: one receiving neurodevelopmental treatment (NDT; n = 13) and one receiving both NDT and WBV (NDT + WBV; n = 15). The primary outcome measures were 6-minute walking test (6MWT) and pulmonary function test which evaluate functional and respiratory capacity. Secondary outcome included the chest circumference measurement to evaluate the thoracic expansion ability. Both groups showed positive significant changes in walking distance and maximum oxygen consumption volume (VO2max), inspiratory capacity, vital capacity and chest circumference measurement scores (p < 0.05). While the NDT +WBV group showed a significantly greater increase in walking distance and VO2max levels than the NDT group (p < 0.05), there were no significant group differences in respiratory function flow and volume parameters, and chest circumference measurement. The addition of WBV training to the treatment program has some incremental benefits on increasing functional capacity and thoracic expansion, and rehabilitating respiratory dysfunction.

New 6-Minute-Walking Test Parameter-Distance/Desaturation Index (DDI) Correctly Diagnoses Short-Term Response to Immunomodulatory Therapy in Hypersensitivity Pneumonitis.

6MWT parameters (distance, initial saturation, final saturation, desaturation, distance-saturation product (DSP), and DDI) were analyzed at baseline and after 3 to 6 months of treatment with corticosteroids alone or in combination with azathioprine. 91 consecutive HP patients diagnosed and treated in a single pulmonary unit from 2005 to 2017 entered the study. There were 44 (48%) males and 52 (57%) patients with fibrotic HP (fHP). Sixty-three patients (69%) responded to treatment (responders) and 28 (31%) did not respond (non-responders). In the responders group, all parameters assessed during 6MWT significantly improved, whereas in non-responders, they worsened. Medians (95% CI) of best indices were post-treatment DDI/baseline DDI-1.67 (1.85-3.63) in responders versus 0.88 (0.7-1.73) in non-responders (p = 0.0001) and change in walking distance-51 m (36-72 m) in responders, versus 10.5 m (-61.2-27.9) in non-responders (p = 0.0056). The area under the curve (AUC) of receiver operating characteristics (ROC) for post-treatment DDI/baseline DDI was 0.74 and the optimal cut-off was 1.075, with 71% of specificity and 71% of sensitivity. 6MWT may be used as a tool to assess and monitor the response to immunomodulatory therapy in HP patients, especially if indices incorporating both distance and desaturation are used. Based on the present study results, we recommend 6MWD and DDI use, in addition to FVC and TL,co, to monitor treatment efficacy in patients with interstitial lung diseases.

Early Heart Rate Recovery after a 6-min Walking Test Predicts Clinical Benefits in Patients after Percutaneous Aortic Valve Implantation.

It was hypothesized that the time-appropriate return to a resting heart rate (HR) after cessation of exercise could be a marker for predicting outcomes in patients with heart failure (HF). We aimed to evaluate the prognostic value of HR recovery in functional improvement among adults with severe aortic stenosis undergoing percutaneous aortic valve implantation (TAVI). We performed a 6 min walk test (6MWT) in 93 individuals before TAVI and 3 months after the procedure. The change in walking distance was calculated. During the pre-TAVI 6MWT, we analyzed the differences between baseline HR, HR at the end of the test, and HR at the 1st, 2nd, and 3rd minute of recovery. After 3 months, 6MWT distances improved by 39 ± 63 m and reached a total of 322 ± 117 m. Multiple linear regression proved the differences between HR after 2 min of recovery and baseline HR in pre-TAVI after a 6MWT was the only significant predictor of waking distance improvement during follow-up. Our study suggests that analysis of HR recovery after a 6MWT may be a helpful and easy parameter to assess improvements in exercise capacity after TAVI. This simple method can help to identify patients in whom no significant benefit in functional improvement can be expected despite successful valve implantation.

Lung function and collagen 1a levels are associated with changes in 6 min walk test distance during treatment of TB among HIV-infected adults: a prospective cohort study

BackgroundPatients with tuberculosis (TB) and HIV often present with impairments in lung function and exercise capacity after treatment. We evaluated clinical and immunologic variables associated with a minimum clinically important difference (MCID) in the change in the 6 min walk test distance during the first 24 weeks of antiretroviral (ART) and anti-tubercular therapy.MethodsAdults initiating ART and anti-TB treatment in the setting of newly-diagnosed HIV and pulmonary TB were enrolled in a prospective cohort study in South Africa. Patients underwent 6 min walk tests and spirometry at weeks 0, 4, 12, and 24 and biomarker level measurements early during treatment, at weeks 0, 4, and 12, when inflammation levels are typically elevated. Biomarkers included matrix metalloproteinases-1 (MMP-1), tissue inhibitor of MMP (TIMP)-1, collagen 1a, IL-6, IL-8, vascular cell adhesion molecule 1 (VCAM-1), C-X-C motif chemokine 10 (CXCL-10), CXCL-11, macrophage colony-stimulating factor (M-CSF), plasminogen activator, vascular endothelial growth factor, and chemokine (C-C) motif-2 (CCL-2). An MCID was derived statistically, and achievement of an MCID was modeled as the outcome using logistic regression model.ResultsEighty-nine patients walked an average of 393 (± standard deviation = 69) meters at baseline, which increased by an average of 9% (430 ± 70 m) at week 24. The MCID for change in walk distance was estimated as 41 m. Patients experiencing an MCID on treatment had worse lung function, lower 6 min walk test distance, higher levels of proinflammatory biomarkers including TIMP-1 and M-CSF, and lower levels of collagen 1a at baseline. Experiencing an MCID during treatment was associated with increases in forced expiratory volume in 1-s [odds ratio (OR) = 1.17, 95% confidence interval (CI) = 1.05–1.33] and increases in blood collagen 1a levels (OR = 1.31, 95%CI 1.06–1.62).ConclusionsART and TB treatment are associated with substantial improvements in 6 min walk test distance over time. Achievement of an MCID in the 6 min walk test in this study was associated with more severe disease at baseline and increases in collagen 1a levels and lung function during therapy.

Network Meta-Analysis of Trials Testing If Home Exercise Programs Informed by Wearables Measuring Activity Improve Peripheral Artery Disease Related Walking Impairment.

Background: This study aimed to investigate whether home exercise programs informed by wearable activity monitors improved walking ability of patients with peripheral artery disease (PAD). Methods: A systematic literature search was performed to identify randomised controlled trials (RCT) testing home exercise that were or were not informed by wearable activity monitors. The primary outcome was the change in walking distance measured by a six-minute walking test or treadmill test over the course of the trial. Network meta-analysis (NMA) was performed using the gemtc R statistical package. The risk of bias was assessed using Cochrane tool for assessing risk of bias in RCTs (RoB 2.0). Results: A total of 14 RCTs involving 1544 participants were included. Nine trials used wearable activity monitors to inform the home exercise program tested, while five trials did not use wearable activity monitors to inform the home exercise program tested. Overall quality assessment showed 12 trials to be at low risk of bias and two trials at high risk of bias. Home exercise programs informed by wearable activity monitors significantly improved walking distance compared to non-exercise controls (Mean difference, MD: 32.8 m [95% credible interval, CrI: 6.1, 71.0]) but not compared to home exercise programs not informed by wearable activity monitors (MD: 4.7 m [95% CrI: −38.5, 55.4]). Conclusions: Home exercise informed by wearable activity monitors improve walking ability of patients with PAD. It is, however, unclear if activity monitoring informed exercise programs are more effective than exercise programs not using activity monitors.

Changes in pain scores and walking distance after epidural steroid injection in patients with lumbar central spinal stenosis.

Lumbar spinal stenosis is a common degenerative disorder that is characterized by pain and neurogenic claudication. Previous studies have evaluated the effects of an epidural steroid injection (ESI) on spinal stenosis, based on changes to the spinal canal diameter.This study aimed to examine the impact of the ESI on pain scores and walking distance in patients with lumbar central spinal stenosis, stratified based on disease severity, which was graded according to the degree of cauda equina separation.We reviewed the medical records of patients who received the ESI for lumbar spinal central canal stenosis. A total of 128 patients were divided into moderate and severe groups, based on the degree of cauda equina separation.Relative to baseline values, 2 weeks after the ESI, the moderate group showed a significant decrease in the numeric rating scale (NRS) scores and an increase in walking distance. Meanwhile, the severe group showed a significant decrease in the NRS scores and no significant change in walking distance. The moderate group had lower NRS scores and a longer walking distance than did the severe group 2 weeks after the ESI. The proportion of patients with improved levels of satisfaction was higher in the moderate group than in the severe group.Lumbar interlaminar ESI may reduce pain scores and increase walking distance in patients with moderate lumbar spinal central canal stenosis. Patients with moderate spinal stenosis achieved better outcomes than did patients with severe stenosis.

The Borg scale is a sustainable method for prescribing and monitoring self-administered aerobic endurance exercise in patients with chronic kidney disease

Aim To examine adherence, performance, and safety of self-administered aerobic endurance exercise when exercise intensity was prescribed and self-monitored with the Borg RPE scale in patients with chronic kidney disease (CKD), and the relationship between performed exercise and change in walking distance. Materials and Methods 97 men and 50 women (age 66 ± 14 years, measured GFR 22 ± 8 mL/min/1.73m2) were prescribed 60 min aerobic endurance exercise/week at RPE 13–15. The 6-minute walk test was measured at 0, 4, 8 and 12 months of exercise. Results 100 patients completed the study, 80% reported exercise intensity at 12 months, 74% performed exercise within the prescribed RPE. Median RPE was 13 (13–15). Median duration was 56 (33–109) minutes/week. Patients with a short walking distance at baseline performed significantly less minutes of exercise/week (p = 0.039). There was no correlation between weekly duration and change in walking distance. No exercise-related incidents were recorded. Walking distance improved significantly by 30 ± 56 metres (p < 0.001). Conclusions The Borg RPE scale is useful, acceptable, simple and safe for prescribing and monitoring intensity of self-administered aerobic endurance exercise in patients with CKD. A RPE of 13–15 improved walking distance in well-functioning and deconditioned patients, within a wide range of weekly duration of exercise.

MO601: Using the Borg Scale for Exercise Prescription and for Monitoring Self-Administered Aerobic Endurance Exercise is Safe and Effective for Patients with CKD

Abstract BACKGROUND AND AIMS Decline in physical function starts relatively early in the course of CKD and has an impact on activities in daily life, such as walking capacity. Several studies with supervised centre-based exercise training as well as studies with self-administered home-based exercise have shown improvement in walking capacity. However, monitoring intensity and safety is important when exercise is self-administrated. There are to our knowledge no studies evaluating the Borg RPE scale as a tool to prescribe exercise intensity and as an instrument for self-monitoring exercise training in patients with CKD. The aims of this study were to examine the adherence, performance, and safety of self-administered aerobic endurance exercise when exercise intensity was prescribed and self-monitored with the Borg rating of perceived exertion (RPE) scale in non-dialysis dependent patients with CKD stages 3–5, and the relationship between performed exercise and change in walking distance. METHOD In this sub-study of the RENEXC trial 147 patients (97 men, 50 women), irrespective of age and comorbidities, were included. Mean age was 66 ± 14 years and the mean measured GFR 22 ± 8 mL/min/1.73 m2. Twelve months of aerobic endurance exercise (60 min/week) was combined with either balance or strength exercises (90 min/week). All exercise was individually prescribed by a research physiotherapist, based on each patient's baseline tests. The aerobic endurance exercise was prescribed to have a level of intensity between 13 (somewhat strenuous) to 15 (strenuous) using the Borg RPE scale. Exercise was self-monitored and recorded in a training diary. Follow up was performed by the physiotherapist through phone contact. The 6-min walk test was measured at baseline and after 4, 8 and 12 months of exercise. RESULTS Hundred patients completed the study. Our training program had an excellent level of adherence, at 12 months 80% of the patients reported performed exercise and 74% performed exercise within the prescribed intensity. The mean intensity of the aerobic endurance exercise was rated at 13 ± 1 on the Borg RPE scale. Median duration of aerobic endurance exercise was 56 (33–109) minutes/week. However, there was a wide range of weekly duration where patients with a low walking distance at baseline performed less minutes of exercise/week (P = 0.039). Irrespective of weekly duration the patients were able to perform exercise within the prescribed interval of RPE 13–15. No exercise related incidents were reported. Walking distance improved significantly by mean 30 ± 56 meters (P &amp;lt; 0.001). There was no correlation between weekly duration of exercise and change in walking distance, indicating that deconditioned patients with a short baseline walking distance can increase walking capacity when performing a shorter weekly duration of somewhat strenuous to strenuous exercise, whereas patients with a higher baseline walking distance must perform a longer duration of exercise to increase walking capacity. CONCLUSION The Borg RPE scale is a useful, acceptable, simple and safe method for prescribing and monitoring intensity of self-administered aerobic endurance exercise in patients with CKD. A RPE of somewhat strenuous to strenuous improved walking capacity in deconditioned patients with CKD, within a wide range of weekly duration of exercise.

Use of a Smartphone App Versus Motivational Interviewing to Increase Walking Distance and Weight Loss in Overweight/Obese Adults With Peripheral Artery Disease: Pilot Randomized Trial.

BackgroundWalking therapy improves functional outcomes in patients with peripheral artery disease (PAD). Less is known about the additive benefit of a dietary intervention.ObjectiveOur objectives were to develop a smartphone app and, as a pilot, explore its potential efficacy as compared to motivational interviewing (MI) to increase walking distance and promote weight loss in overweight/obese adults with PAD.MethodsWe conducted a 3-month, 2-arm randomized pilot study at the University of Kansas. Inclusion criteria were BMI >27 kg/m2 and symptomatic PAD, defined by an ankle-brachial index <0.9. Patients were randomized into 2 groups: MI, delivered through in-person and telephone counseling, and app, a mobile smartphone app. Both interventions encouraged walking for exercise and healthy dietary habits (increasing fruits and vegetables and whole grains while reducing fat and sugary drinks). We assessed medical history at baseline. At baseline and 3 months, participants completed an assessment of 6-minute walking distance, weight, quality of life, exercise behaviors, and dietary habits. The primary outcome was 3-month change in walking distance. Secondary outcomes were changes in weight, quality of life, exercise behaviors, and dietary habits. We used a Wilcoxon rank-sum test to analyze the primary and secondary outcomes at 3 months within the MI and app groups and to compare the changes between the groups with adjustment for baseline.ResultsWe randomized 29 participants with a mean age of 66.03 (SD 8.12) years; 25 participants completed the trial. At baseline, mean walking distance among completers was 260.40 (SD 94.32) meters and 326.15 (SD 69.28) meters for MI and app participants, respectively. At 3 months, the mean walking distance was 298.67 (SD 101.20) meters and 331.19 (SD 58.63) meters for MI and app participants, respectively (group difference P=.03, adjusting for baseline). Increase in walking distance at 3 months was 40.5 meters (95% CI 6.77 to 61.34; P=.02) in MI group. At baseline, mean body weight was 253.10 (SD 59.45) lbs and 225.13 (SD 58.93) lbs for MI and app participants, respectively. At 3 months, mean body weight was 242.14 (SD 58.54) lbs and 223.44 (SD 59.54) lbs for MI and app, respectively (group difference P=.006, adjusting for baseline). Pre-post study decrease in weight was 10.1 lbs (95% CI –17.9 to –3.0) and 2.3 lbs (95% CI –3.4 to –0.7) in MI and app group, respectively. Comparing baseline to 3 months, there were no statistically significant differences in quality of life, exercise behaviors, or dietary habits.ConclusionsOur study demonstrates that MI can promote walking and weight loss in overweight/obese adults with PAD. The smartphone app showed a small weight loss but no statistically significant increase in walking distance. As this was a pilot study, future large-scale studies are needed to replicate the efficacy of MI to promote weight loss in overweight or obese adults with PAD.Trial RegistrationClinicalTrials.gov NCT03694652; https://clinicaltrials.gov/ct2/show/NCT03694652

Six-minute walk test: prognostic value and effects of nebivolol versus placebo in elderly patients with heart failure from the SENIORS trial.

There is limited information about the 6-min walk test (6MWT) in elderly patients with heart failure. We evaluated 6MWT and the effect of nebivolol on 6MWT from the SENIORS trial. The SENIORS trial evaluated nebivolol versus placebo on death and hospitalisation in patients aged ≥ 70years with heart failure. A total of 1982 patients undertook a 6MWT at baseline and 1716 patients at 6months. Patients were divided into tertiles (≤ 200m, 201 to ≤ 300m and > 300m) and to change in distance walked between baseline and 6months (< 0m, 0 to < 30m and ≥ 30m). The primary outcome was all-cause mortality and cardiovascular hospital admission. Secondary endpoint was all-cause mortality. Baseline walk distance of ≤ 200m incurred a greater risk of the primary and secondary outcomes (HR 1.41, CI 95% 1.17-1.69, p < 0.001) and (HR 1.37, CI 95% 1.05-1.78, p = 0.019). A decline in walk distance over 6months was associated with increased risk of clinical events. Nebivolol had no influence on change in walk distance over 6months. The 6MWT has prognostic utility in elderly patients. Those who walked less than 200m were at highest risk. Nebivolol had no effect on 6MWT.

Short-Term Exercise Progression of Cardiovascular Patients throughout Cardiac Rehabilitation: An Observational Study.

Cardiac rehabilitation (CR) is a highly recommended secondary prevention measure for patients with diagnosed cardiovascular disease. Unfortunately, participation rates are low due to enrollment and adherence issues. As such, new CR delivery strategies are of interest, as to improve overall CR delivery. The goal of the study was to obtain a better understanding of the short-term progression of functional capacity throughout multidisciplinary CR, measured as the change in walking distance between baseline six-minute walking test (6MWT) and four consecutive follow-up tests. One-hundred-and-twenty-nine patients diagnosed with cardiovascular disease participated in the study, of which 89 patients who completed the whole study protocol were included in the statistical analysis. A one-way repeated measures ANOVA was conducted to determine whether there was a significant change in mean 6MWT distance (6MWD) throughout CR. A three-way-mixed ANOVA was performed to determine the influence of categorical variables on the progression in 6MWD between groups. Significant differences in mean 6MWD between consecutive measurements were observed. Two subgroups were identified based on the change in distance between baseline and end-of-study. Patients who increased most showed a linear progression. In the other group progression leveled off halfway through rehabilitation. Moreover, the improvement during the initial phase of CR seemed to be indicative for overall progression. The current study adds to the understanding of the short-term progression in exercise capacity of patients diagnosed with cardiovascular disease throughout a CR program. The results are not only of interest for CR in general, but could be particularly relevant in the setting of home-based CR.

A short-term oral corticosteroid for refractory lumbar spinal stenosis: a double-blinded randomized placebo-controlled clinical trial.

Although epidural corticosteroids have been evaluated for the lumbar spinal stenosis (LSS) as an alternative treatment, oral corticosteroids have not been considered as a possible option for the patients with constant pain who have resistant against routine treatments. Therefore, this study aimed to investigate the efficacy of the short-term, low-dose oral prednisolone for refractory LSS. In this double-blinded randomized placebo-controlled clinical trial, 100 participants with the refractory LSS were selected from the out-patient clinics; however, 7 of them excluded before randomization. The patients were randomly allocated into two groups with a 1:1 ratio: the intervention group that received 10 mg prednisolone per day for 1 week and the control group that received the exact placebo. The patients' severity of pain in terms of the numerical rating scale, ability to walk in meters, and Oswestry Disability Index (ODI) were assessed and then compared to the baseline after 2 months. The baseline variables were NS between these two groups. At the 2-month follow-up, the ability to walk in meters has increased and the severity of pain and ODI have decreased in both groups. Notably, except for the walking distance, none of the differences were statistically significant. Except for the significant change in walking distance between the groups, no other significant difference was observed in any variables when comparing the delta of each variable (after-before). One-week treatment with daily 10 mg oral prednisolone was not effective on the patients with refractory LSS in the short-term follow-up.

Pulmonary Hypertension Roundtable: Drug Development and Negative Clinical Trial Results

Pulmonary Hypertension Roundtable: Drug Development and Negative Clinical Trial Results