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Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Post-stroke physical inactivity is explained by several factors related to the stroke, which have been suggested as the causes and consequences of functional declines and health problems. Therefore, it is important to increase physical activity levels and reduce the time spent in low-energy expenditure activities after a stroke. Since the maintenance of cardiorespiratory fitness is a significant predictor of physical activity levels post-stroke, it may be important to investigate whether aerobic training is effective in increasing physical activity levels and reducing the time spent in low-energy expenditure activities in this population. The efficacy of aerobic training on these variables is not well known. The primary objective of this trial will be to investigate the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities in people with stroke. The secondary aim will be to evaluate the effects of the training on cardiorespiratory fitness, endurance, depression, mobility, quality of life, and participation. METHODS/DESIGN:A randomized controlled trial, with blinded assessments, will be performed in a community-based setting. Altogether, 22 adults with a diagnosis of stroke (>6 months) who are sedentary or insufficiently active will be included. Participants will be randomly assigned to either: (1) aerobic treadmill training (experimental group, at 60-80% of their heart rate reserve) or (2) walking outside (control group, below 40% of heart rate reserve). Both groups will attend 40-min training sessions, three times per week over 12 weeks, in groups of two to four participants, with a trained physiotherapist. Primary outcomes are physical activity levels and time spent in low-energy expenditure activities (Multi-sensor SenseWear Mini® and Human Activity Profile). Secondary outcomes are cardiorespiratory fitness (peak oxygen uptake VO2peak and ventilatory threshold), endurance, depression, mobility, quality of life, and participation. The effects of the training will be analyzed from the collected data using intention to treat. Between-group differences will be measured by two-way repeated measures ANOVA, considering the baseline, post-training, and 4-week follow-up. DISCUSSION:The results of this trial will likely provide valuable new information on the effects of aerobic treadmill training on physical activity levels and on time spent in low-energy expenditure activities of individuals with stroke, through changes in cardiorespiratory fitness. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02798237 . Registered on 13 June 2016.

SUBMITTER: Aguiar LT

PROVIDER: S-EPMC6098648 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial.

Aguiar Larissa Tavares LT Nadeau Sylvie S Britto Raquel Rodrigues RR Teixeira-Salmela Luci Fuscaldi LF Martins Júlia Caetano JC Faria Christina Danielli Coelho de Morais CDCM

Trials 20180817 1

<h4>Background</h4>Post-stroke physical inactivity is explained by several factors related to the stroke, which have been suggested as the causes and consequences of functional declines and health problems. Therefore, it is important to increase physical activity levels and reduce the time spent in low-energy expenditure activities after a stroke. Since the maintenance of cardiorespiratory fitness is a significant predictor of physical activity levels post-stroke, it may be important to investig ...[more]

PMID: 30119697

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Project description:BACKGROUND:Given the rising number of strokes worldwide, and the large number of individuals left with disabilities after stroke, novel strategies to reduce disability, increase functions in the motor and the cognitive domains, and improve quality of life are of major importance. Physical activity is a promising intervention to address these challenges but, as yet, there is no study demonstrating definite outcomes. Our objective is to assess whether additional treatment in the form of physical fitness-based training for patients early after stroke will provide benefits in terms of functional outcomes, in particular gait speed and the Barthel Index (co-primary outcome measures) reflecting activities of daily living (ADL). We will gather secondary functional outcomes as well as mechanistic parameters in an exploratory approach. METHODS/DESIGN:Our phase III randomised controlled trial will recruit 215 adults with moderate to severe limitations of walking and ADL 5 to 45 days after stroke onset. Participants will be stratified for the prognostic variables of "centre", "age", and "stroke severity", and randomly assigned to one of two groups. The interventional group receives physical fitness training delivered as supported or unsupported treadmill training (cardiovascular active aerobic training; five times per week, over 4 weeks; each session 50 minutes; total of 20 additional physical fitness training sessions) in addition to standard rehabilitation treatment. The control intervention consists of relaxation sessions (non-cardiovascular active; five times per week week, over 4 weeks; each session 50 minutes) in addition to standard rehabilitation treatment. Co-primary efficacy endpoints will be gait speed (in m/s, 10 m walk) and the Barthel Index (100 points total) at 3 months post-stroke, compared to baseline measurements. Secondary outcomes include standard measures of quality of life, sleep and mood, cognition, arm function, maximal oxygen uptake, and cardiovascular risk factors including blood pressure, pulse, waist-to-hip ratio, markers of inflammation, immunity and the insulin-glucose pathway, lipid profile, and others. DISCUSSION:The goal of this endpoint-blinded, phase III randomised controlled trial is to provide evidence to guide post-stroke physical fitness-based rehabilitation programmes, and to elucidate the mechanisms underlying this intervention. TRIAL REGISTRATION:Registered in ClinicalTrials.gov with the Identifier NCT01953549.

Project description:BackgroundThis feasibility study is intended to assess the acceptability of home-based task-specific reach-to-grasp (RTG) training for people with stroke, and to gather data to inform recruitment, retention, and sample size for a definitive randomized controlled trial.Methods/designThis is to be a randomized controlled feasibility trial recruiting 50 individuals with upper-limb motor impairment after stroke. Participants will be recruited after discharge from hospital and up to 12 months post-stroke from hospital stroke services and community therapy-provider services. Participants will be assessed at baseline, and then electronically randomized and allocated to group by minimization, based on the time post-stroke and extent of upper-limb impairment. The intervention group will receive 14 training sessions, each 1 hour long, with a physiotherapist over 6 weeks and will be encouraged to practice independently for 1 hour/day to give a total of 56 hours of training time per participant. Participants allocated to the control group will receive arm therapy in accordance with usual care. Participants will be measured at 7 weeks post-randomization, and followed-up at 3 and 6 months post-randomization. Primary outcome measures for assessment of arm function are the Action Research Arm Test (ARAT) and Wolf Motor Function Test (WMFT). Secondary measures are the Motor Activity Log, Stroke Impact Scale, Carer Strain Index, and health and social care resource use. All assessments will be conducted by a trained assessor blinded to treatment allocation. Recruitment, adherence, withdrawals, adverse events (AEs), and completeness of data will be recorded and reported.DiscussionThis study will determine the acceptability of the intervention, the characteristics of the population recruited, recruitment and retention rates, descriptive statistics of outcomes, and incidence of AEs. It will provide the information needed for planning a definitive trial to test home-based RTG training.Trial registration isrctnISRCTN56716589.

Project description:BackgroundStroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects.MethodsIn this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried.DiscussionThe final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment.Trial registrationClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.

Project description:BackgroundPhysicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise.MethodsWe conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention) or to a blinded monitor (control). Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1) median steps/day and 2) proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day). Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses.ResultsIn Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16) and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73). In Phase 2 (team competition), residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002;Intervention7,832 vs. 7,739, p = 0.13). Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001). Mean systolic blood pressure decreased (p = 0.004) and HDL cholesterol increased (p<0.001) among all participants at end of study compared to baseline.ConclusionsAlthough the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more intensive hospital-based wellness programs have potential for promoting healthier lifestyles among physicians.Trial registrationClinicaltrials.gov NCT01287208.

Project description:Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines.A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families.This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families.This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192.

Project description:The number of falls experienced by people with knee osteoarthritis (OA) is almost double the number experienced by people with no OA. The neuromuscular elements required to arrest a fall are more impaired in people with knee OA compared to their asymptomatic counterparts. Therefore, these elements may need to be incorporated into an exercise intervention to reduce the risk of falling. The aim of this study will be to examine the feasibility, safety and patient satisfaction of a high-speed resistance-training program, with and without balance exercises, in people with knee OA compared to a control group. The effect of these exercise programs on lower-limb muscle strength and physiological and functional risk factors for falls will also be examined.This study will be a pilot randomized controlled trial with a pre- and post-intervention design (outcome assessments at baseline and 8 weeks after participation commencement) comparing three groups: a control group (no intervention), a high-speed resistance-training group and a high-speed resistance-training plus balance exercises group. Thirty people with knee osteoarthritis aged 60-90 years will be recruited and randomized to one of the three groups. Feasibility and safety will be assessed by examining adherence to the exercise program, dropout rate, pain level during and following exercise, number of exercises stopped due to pain, and any adverse event or any incident that prevents the participant from completing the prescribed exercise. Secondary measures of lower-limb strength, physical function, self-reported pain and function, fear of falls, and executive function and quality of life will also be assessed. To determine statistical trends of effectiveness and hence to inform sample size for a fully powered study, analyses of the secondary outcomes will be performed to assess the changes within and between groups over time (pre-post) using repeated measure ANOVA.The results of this study will improve understanding of what type of exercise is safe and beneficial for people with knee OA to reduce their risk of falling, and hence will inform the development of a future large research trial.Australian New Zealand Clinical Trials Registry, ID: ACTRN12616001382460 . Registered on 6 October 2016.

Project description:IntroductionPhysical inactivity and excessive sedentary behaviours are major preventable causes in both the development and the treatment of obesity and type 2 diabetes mellitus (T2DM). Nevertheless, current programmes struggle to engage and sustain physical activity (PA) of patients over long periods of time. To overcome these limitations, the Digital Intervention Promoting Physical Activity among Obese people randomised controlled trial (RCT) aims to evaluate the effectiveness of a group-based digital intervention grounded on gamification strategies, enhanced by social features and informed by the tenets of the self-determination theory and the social identity approach.Methods and analysisThis trial is a two-arm parallel RCT testing the effectiveness of the Kiplin digital intervention on obese and patients with T2DM in comparison to the usual supervised PA programme of the University Hospital of Clermont-Ferrand, France. A total of 50 patients will be randomised to one of the two interventions and will follow a 3-month programme with a 6-month follow-up postintervention. The primary outcome of the study is the daily step count change between the baseline assessment and the end of the intervention. Accelerometer data, self-reported PA, body composition and physical capacities will also be evaluated. To advance our understanding of complex interventions like gamified and group-based ones, we will explore several psychological mediators relative to motivation, enjoyment, in-group identification or perceived weight stigma. Finally, to assess a potential superior economic efficiency compared with the current treatment, we will conduct a cost-utility analysis between the two conditions. A mixed-model approach will be used to analyse the change in outcomes over time.Ethics and disseminationThe research protocol has been reviewed and approved by the Local Human Protection Committee (CPP Ile de France XI, No 21 004-65219). Results will inform the Kiplin app development, be published in scientific journals and disseminated in international conferences.Trial registration numberNCT04887077.

Dataset Information

Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial.

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Effects of aerobic training on physical activity in people with stroke: protocol for a randomized controlled trial.

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