Dataset Information

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke.

ABSTRACT:

Rationale

Cardiovascular exercise is an effective method to improve cardiovascular health outcomes, but also promote neuroplasticity during stroke recovery. Moderate-intensity continuous cardiovascular training (MICT) is an integral part of stroke rehabilitation, yet it may remain a challenge to exercise at sufficiently high intensities to produce beneficial adaptations to neuroplasticity. High-intensity interval training (HIIT) could provide a viable alternative to achieve higher intensities of exercise by using shorter bouts of intense exercise interspersed with periods of recovery.

Methods and design

This is a two-arm, parallel-group multi-site RCT conducted at the Jewish Rehabilitation Hospital (Laval, Québec, Canada) and McMaster University (Hamilton, Ontario, Canada). Eighty participants with chronic stroke will be recruited at both sites and will be randomly allocated into a HIIT or MICT individualized exercise program on a recumbent stepper, 3 days per week for 12 weeks. Outcomes will be assessed at baseline, at 12 weeks post-intervention, and at an 8-week follow-up.

Outcomes

The primary outcome is corticospinal excitability, a neuroplasticity marker in brain motor networks, assessed with transcranial magnetic stimulation (TMS). We will also examine additional markers of neuroplasticity, measures of cardiovascular health, motor function, and psychosocial responses to training.

Discussion

This trial will contribute novel insights into the effectiveness of HIIT to promote neuroplasticity in individuals with chronic stroke.

Trial registration

ClinicalTrials.gov NCT03614585 . Registered on 3 August 2018.

SUBMITTER: Rodrigues L

PROVIDER: S-EPMC9127488 | biostudies-literature | 2022 May

REPOSITORIES: biostudies-literature

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Publications

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke.

Rodrigues Lynden L Moncion Kevin K Eng Janice J JJ Noguchi Kenneth S KS Wiley Elise E de Las Heras Bernat B Sweet Shane N SN Fung Joyce J MacKay-Lyons Marilyn M Nelson Aimee J AJ Medeiros Diogo D Crozier Jennifer J Thiel Alexander A Tang Ada A Roig Marc M

Trials 20220524 1

<h4>Rationale</h4>Cardiovascular exercise is an effective method to improve cardiovascular health outcomes, but also promote neuroplasticity during stroke recovery. Moderate-intensity continuous cardiovascular training (MICT) is an integral part of stroke rehabilitation, yet it may remain a challenge to exercise at sufficiently high intensities to produce beneficial adaptations to neuroplasticity. High-intensity interval training (HIIT) could provide a viable alternative to achieve higher intens ...[more]

PMID: 35610659

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Project description:BackgroundStroke results in neurologic impairments and aerobic deconditioning that contribute to limited walking capacity which is a major barrier post-stroke. Current exercise recommendations and stroke rehabilitation guidelines recommend moderate-intensity aerobic training post-stroke. Locomotor high-intensity interval training is a promising new strategy that has shown significantly greater improvements in aerobic fitness and motor performance than moderate-intensity aerobic training in other populations. However, the relative benefits and risks of high-intensity interval training and moderate-intensity aerobic training remain poorly understood following stroke. In this study, we hypothesize that locomotor high-intensity interval training will result in greater improvements in walking capacity than moderate-intensity aerobic training.MethodsUsing a single-blind, 3-site randomized controlled trial, 50 chronic (> 6 months) stroke survivors are randomly assigned to complete 36 locomotor training sessions of either high-intensity interval training or moderate-intensity aerobic training. Main eligibility criteria are age 40-80 years, single stroke for which the participant received treatment (experienced 6 months to 5 years prior to consent), walking speed ≤ 1.0 m/s, able to walk at least 3 min on the treadmill at ≥ 0.13 m/s (0.3 mph), stable cardiovascular condition (American Heart Association class B), and the ability to walk 10 m overground without continuous physical assistance. The primary outcome (walking capacity) and secondary outcomes (self-selected and fast gait speed, aerobic fitness, and fatigue) are assessed prior to initiating training and after 4 weeks, 8 weeks, and 12 weeks of training.DiscussionThis study will provide fundamental new knowledge to inform the selection of intensity and duration dosing parameters for gait recovery and optimization of aerobic training interventions in chronic stroke. Data needed to justify and design a subsequent definitive trial will also be obtained. Thus, the results of this study will inform future stroke rehabilitation guidelines on how to optimally improve walking capacity following stroke.Trial registrationClinicalTrials.gov NCT03760016 . Registered on November 30, 2018.

Project description:BackgroundThe majority of stroke survivors return to their homes and need assistance from family caregivers to perform activities of daily living. These increased demands coupled with the lack of preparedness for their new roles lead to a high risk for caregivers developing depressive symptoms and other negative outcomes. Follow-up home support and problem-solving interventions with caregivers are crucial for maintaining stroke survivors in their homes. Problem-solving interventions are effective but are underused in practice because they require large amounts of staff time to implement and are difficult for caregivers logistically.ObjectiveThe aim of this study is to test a problem-solving intervention for stroke caregivers that can be delivered over the telephone during the patient's transitional care period (time when the stroke survivor is discharged to home) followed by 8 asynchronous online sessions.MethodsThe design is a two-arm parallel randomized clinical trial with repeated measures. We will enroll 240 caregivers from eight Veterans Affairs (VA) medical centers. Participants randomized into the intervention arm receive a modified problem-solving intervention that uses telephone and web-based support and training with interactive modules, fact sheets, and tools on the previously developed and nationally available Resources and Education for Stroke Caregivers' Understanding and Empowerment Caregiver website. In the usual care group, no changes are made in the information, discharge planning, or care the patients who have had a stroke normally receive, and caregivers have access to existing VA resources (eg, caregiver support line, self-help materials). The primary outcome is a change in caregiver depressive symptoms at 11 and 19 weeks after baseline data collection. Secondary outcomes include changes in stroke caregivers' burden, knowledge, positive aspects of caregiving, self-efficacy, perceived stress, health-related quality of life, and satisfaction with care and changes in stroke survivors' functional abilities and health care use. The team will also determine the budgetary impact, facilitators, barriers, and best practices for implementing the intervention. Throughout all phases of the study, we will collaborate with members of an advisory panel.ResultsStudy enrollment began in June 2015 and is ongoing. The first results are expected to be submitted for publication in 2021.ConclusionsThis is the first known study to test a transitional care and messaging center intervention combined with technology to decrease caregiver depressive symptoms and to improve the recovery of stroke survivors. If successful, findings will support an evidence-based model that can be transported into clinical practice to improve the quality of caregiving post stroke.Trial registrationClinicalTrials.gov NCT01600131; https://www.clinicaltrials.gov/ct2/show/NCT01600131.International registered report identifier (irrid)DERR1-10.2196/21799.

Project description:BackgroundPhysical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a high-intensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (ie, steps/day). We hypothesized the combined intervention would yield the greatest increase in steps/day.MethodsThis assessor-blinded multisite randomized controlled trial was conducted at 4 university/hospital-based laboratories. Participants were 21 to 85 years old, walking without physical assistance following a single, unilateral noncerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities at 70% to 80% heart rate reserve, while SAM received daily feedback and goal setting of walking activity (steps/day). Assessors and study statistician were masked to group assignment. The a priori-determined primary outcome and end point was a comparison of the change in steps/day between the 3 intervention groups from pre- to post-intervention. Adverse events were tracked after randomization. All randomized participants were included in the intent-to-treat analysis.ResultsParticipants were enrolled from July 18, 2016, to November 16, 2021. Of 2385 participants initially screened, 250 participants were randomized (mean [SE] age, 63 [0.80] years; 116 females/134 males), with 89 assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps/day significantly increased in both the SAM (mean [SE], 1542 [267; 95% CI, 1014-2069] P<0.001) and FAST+SAM group (1307 [280; 95% CI, 752-1861] P<0.001) but not in the FAST group (406 [238; 95% CI, -63 to 876] P=0.09). There were no deaths or serious study-related adverse events.ConclusionsOnly individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps/day).RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT02835313.

Project description:BackgroundPhysical inactivity in people with chronic stroke profoundly affects daily function and increases recurrent stroke risk and mortality, making physical activity improvements an important target of intervention. We compared the effects of a high-intensity walking intervention (FAST), a step activity monitoring behavioral intervention (SAM), or a combined intervention (FAST+SAM) on physical activity (i.e., steps per day). We hypothesized the combined intervention would yield the greatest increase in steps per day.MethodsThis assessor-blinded multi-site randomized controlled trial was conducted at four university/hospital-based laboratories. Participants were 21-85 years old, walking without physical assistance following a single, unilateral non-cerebellar stroke of ≥6 months duration, and randomly assigned to FAST, SAM, or FAST+SAM for 12 weeks (2-3 sessions/week). FAST training consisted of walking-related activities for 40 minutes/session at 70-80% heart rate reserve, while SAM received daily feedback and goal-setting of walking activity (steps per day). Assessors and study statistician were masked to group assignment. The a priori -determined primary outcome and primary endpoint was change in steps per day from pre- to post-intervention. Adverse events (AEs) were tracked after randomization. All randomized participants were included in the intent-to-treat analysis. This study is registered at ClinicalTrials.gov, NCT02835313 .FindingsParticipants were enrolled from July 18, 2016-November 16, 2021. Of 250 randomized participants (mean[SE] age 63[0.80], 116F/134M), 89 were assigned to FAST, 81 to SAM, and 80 to FAST+SAM. Steps per day significantly increased in both the SAM (mean[SE] 1542[267], 95%CI:1014-2069, p <0.001) and FAST+SAM groups (1307[280], 752-1861, p <0.001), but not in the FAST group (406[238], 63-876, p =0.09). There were no deaths or serious study-related AEs and all other minor AEs were similar between groups.InterpretationOnly individuals with chronic stroke who completed a step activity monitoring behavioral intervention with skilled coaching and goal progression demonstrated improvements in physical activity (steps per day).

Project description:BackgroundPeople with post-stroke aphasia commonly receive speech-language therapy (SLT) when they are admitted to hospitals. Commonly, these patients reported communication difficulties in in-patient settings. Augmentative and alternative communication (AAC) has been reported as an effective treatment approach to improve communication effectiveness, language performance, decreasing depression, and improving quality of life for this population. However, little evidence has demonstrated the use of AAC intervention (AACT) in early recovery from people with post-stroke aphasia in in-patient rehabilitation settings for improving these patients' communication effectiveness. The pilot randomized controlled trial (RCT) will explore the effectiveness and feasibility of including AACT in regular SLT for in-patient people with post-stroke aphasia.MethodThis pilot RCT is a single-blind, randomized controlled trial with two parallel groups. Both groups receive a 1-h treatment session, including either both AACT and SLT or SLT only for ten consecutive days. We aim to include 22 in-patient participants with post-stroke aphasia in each group. Participants will be assessed at pre- and post-intervention and 2 weeks after intervention. The primary outcomes are the ability of communication measured by the communication of basic needs subtest in the Functional Assessment of Communication Skills for Adult (FACS) and the overall language performance measured by the Chinese Standard Aphasia Battery (ABC). The secondary outcomes include a 10-min conversation, the 10-item Hospital version of the Stroke Aphasic Depression Questionnaire (SADQH-10), the Stroke-Specific Quality of Life Scale (SS-QOL), and a patient and caregiver satisfaction questionnaire.DiscussionThis pilot RCT will contribute to new scientific evidence to the field of aphasia rehabilitation in early recovery during the in-patient period. The paper describes the trial, which will explore the effect of combining AACT and SLT and SLT only, our choice of primary and secondary outcome measures, and proposed analyses. The study results will provide information for implementing AACT in the regular in-patient SLT of future RCTs.Trial registrationChinese Clinical Trial Registry database (ChiCTR) ChiCTR2000028870 . Registered on 5 January 2020.

Project description:BackgroundMultimodal physical exercises already have well-established benefits for the post-stroke population that influence gait functional capacity, balance, gait, cognition, and quality of life. This type of intervention can be performed in both real and virtual environments. Considering the characteristics of both environments, it is questioned to what extent the combination of interventions in real and virtual environments could result in improvement in post-stroke impairments.Methods/designWe will conduct a randomized clinical trial with three groups: a real multimodal group (RMG), a virtual multimodal group (VMG), and a combined multimodal group (CMG). It was estimated that we will need a sample of 36 participants (12 per group). RMG individuals will only perform multimodal physical exercises in a real environment two times per week for 60 min per session for 15 weeks. VMG individuals will perform exercises of the same duration over the same time frame but only in a virtual environment. CMG individuals will hold a weekly session in a real environment and another weekly session in virtual environment. The primary outcome measure will be health-related quality of life, evaluated using the Stroke Impact Scale; effects on cognition (Montreal Cognitive Assessment), balance (Berg Balance Scale), mobility (Timed Up & Go), self-selected gait speed (10-meter walk test), and gait functional capacity (6-min walk test) will be investigated as secondary outcome measures. Participants will be evaluated before the beginning of the intervention, immediately after the end of the intervention, and at 1-month follow-up without exercise. If the data meet the assumptions of the parametric analysis, the results will be evaluated by analysis of variance (3 × 3) for the group factor, with repeated measures while taking into account the time factor. The post hoc Tukey test will be used to detect differences (α = 0.05).DiscussionThis study represents the first clinical trial to include three groups considering physical exercise in real and virtual environments, isolated and combined, that counterbalances the intensity and volume of training in all groups. This study also includes a control of progression in all groups along the 15-week intervention. The outcome measures are innovative because, according to International Classification of Functioning, Disability and Health, activity and participation are the targets for effectiveness evaluation.Trial registrationCombinação de exercícios físicos multimodais em ambientes real e virtual para indivíduos pós acidente vascular cerebral crônico, RBR-4pt72m . Registered on 29 August 2016.

Dataset Information

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke.

Rationale

Methods and design

Outcomes

Discussion

Trial registration

Publications

Intensity matters: protocol for a randomized controlled trial exercise intervention for individuals with chronic stroke.

Similar Datasets

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