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Completed

NCT Number: NCT01712724

Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke

Both aerobic training (AT) and resistance/strength training (RT) have the potential to improve recovery after stroke. Research conducted in chronic disease and healthy populations suggest that AT and RT "combination therapy" may produce synergistic and superior effects along cognition and mobility domains, when compared to AT alone. However, the effects of a combined training approach (AT+RT) compared to AT alone has not been investigated in people post-stroke.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Rehabilitation Institute

Toronto, Ontario, M5R 1G7, Canada

About this study

Patients referred to Toronto Rehabilitation Institute's Risk Factor Modification and Exercise Program following Stroke (TRI-REPS) will be randomized to either AT+RT or AT alone. Mobility (6 minute walk test), and cognition (Vascular Cognitive Impairment Harmonization Standards) will be measured pre- post 6 months of exercise. Secondary measures will include body composition, and biochemical changes. This project will help to determine an exercise treatment strategy that will guide best practice guidelines aimed at promoting mobility and brain health in people post-stroke.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of stroke (ischemic or hemorrhagic)
  • Ability to walk at least 100 m independently with or without an assistive
  • device with no severe limitations due to pain
  • Living in the community at least 3 months post stroke (no upper limit)
  • Stroke-related motor impairment score of 3-6 on the Chedoke-McMaster Stroke
  • Assessment scale of the leg and/or foot
  • Ability to provide informed consent

Exclusion criteria

  • Unstable angina or orthostatic blood pressure decrease of > 20 mmHg
  • Resting hypertension (SBP > 160 mm Hg or DBP > 100 mm Hg)
  • Diabetes related or other eye/vision complications (severe proliferative retinopathy)
  • Cardiovascular morbidities which would limit exercise tolerance (e.g. heart failure, hypertrophic cardiomyopathy, horizontal or downsloping ST-segment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
  • Musculoskeletal impairments which would preclude safe participation in exercise
  • Cognitive and/or behavioral issues that would significantly limit participation in exercise testing and training, prior unrelated neurological disorders or psychiatric illness
  • Severe communicative aphasia or comprehensive aphasia (as noted in clinical reports)
  • Patients with anxiety disorder, claustrophobia, or pacemaker implantation will be excluded from brain imaging and perfusion measures
  • Exposure to a similar or identical neuropsychological battery within <6 months
  • Currently smoking

Treatment and study plan

combined resistance and aerobic training

Other

For the group randomized to AT+RT, Patients will gradually be progressed from 1-2 sets and then from 10-15 repetitions and then increase resistance by 1.6-5 kg or increase the exercise band level and then reduced repetitions to 10 and repeated this process.

Primary outcomes

  1. Cognitive function

    Time frame: 1 year

    Vascular Cognitive Impairment Harmonization Standards

Secondary outcomes

  1. Body Composition

    Time frame: 1 year

    Fat free mass will be measured by dual energy x-ray absorptiometry

  2. Biochemical Changes (blood samples)

    Time frame: 1 year

    brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein

  3. Functional Mobility

    Time frame: 1 year

    Six minute walk distance

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Heart and Stroke Foundation of Canada
  • Ontario Stroke Network

Registry information

Acronym: TRI-RAvA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 23, 2012
Registry last updated
Nov 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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