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

Not Applicable

Completed

• Conditions: Cerebrovascular Accident

• Registration Number: NCT01712724
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-10-20
• Study First Submitted QC: 2012-10-20
• Study First Posted: 2012-10-23
• Study Start: 2013-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive function	1 year	Vascular Cognitive Impairment Harmonization Standards

Secondary Outcome Measures

Name	Time	Method
Body Composition	1 year	Fat free mass will be measured by dual energy x-ray absorptiometry
Biochemical Changes (blood samples)	1 year	brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein
Functional Mobility	1 year	Six minute walk distance

Trial Locations

Locations (1)

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada