TRI-RAvA: Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01712724

Collaborator

Heart and Stroke Foundation of Canada (Other), Ontario Stroke Network (Other)

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Accident	Other: combined resistance and aerobic training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aerobic Training Walking, elliptical, stationary recumbent or upright cycling will be the modes of AT prescribed depending on individual ability and access to equipment when away from the Centre. Treadmill or overground walking will be considered for those who can sustain high enough speeds and durations to achieve aerobic benefit. Cycle ergometer exercise (upright or recumbent) will be prescribed to patients in addition to walking when stroke-related deficits preclude a sufficient walking speed. The AT group will complete AT 5 d∙wk-1.	Other: combined resistance and aerobic training 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.
Experimental: Combined Resistance and Aerobic Training The AT+RT group will complete AT 3 d∙wk-1 + RT 2 d∙wk-1.The RT exercises will be task specific, incorporating muscle actions that are performed during daily activities. Resistance will be provided by hand-held dumbbells, exercise bands (wrist/ankle attachments), or patients' body weight. A weight load equivalent to 50-60% of 1 repetition maximum will be prescribed on the non-affected limb. On the hemiparetic limb ≥50% of 1 repetition maximum and/or a resistance rated as 13-14 on the Rating of Perceived Exertion scale on the last repetition of the set will be prescribed	Other: combined resistance and aerobic training 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.

Arm

Intervention/Treatment

Active Comparator: Aerobic Training

Walking, elliptical, stationary recumbent or upright cycling will be the modes of AT prescribed depending on individual ability and access to equipment when away from the Centre. Treadmill or overground walking will be considered for those who can sustain high enough speeds and durations to achieve aerobic benefit. Cycle ergometer exercise (upright or recumbent) will be prescribed to patients in addition to walking when stroke-related deficits preclude a sufficient walking speed. The AT group will complete AT 5 d∙wk-1.

Other: combined resistance and aerobic training

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.

Experimental: Combined Resistance and Aerobic Training

The AT+RT group will complete AT 3 d∙wk-1 + RT 2 d∙wk-1.The RT exercises will be task specific, incorporating muscle actions that are performed during daily activities. Resistance will be provided by hand-held dumbbells, exercise bands (wrist/ankle attachments), or patients' body weight. A weight load equivalent to 50-60% of 1 repetition maximum will be prescribed on the non-affected limb. On the hemiparetic limb ≥50% of 1 repetition maximum and/or a resistance rated as 13-14 on the Rating of Perceived Exertion scale on the last repetition of the set will be prescribed

Other: combined resistance and aerobic training

Outcome Measures

Primary Outcome Measures

Cognitive function [1 year]
Vascular Cognitive Impairment Harmonization Standards

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Toronto Rehabilitation Institute	Toronto	Ontario	Canada	M5R 1G7

Sponsors and Collaborators

University Health Network, Toronto
Heart and Stroke Foundation of Canada
Ontario Stroke Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT01712724

Other Study ID Numbers:

OSN1207-000144
OSN1207-000144

First Posted:

Oct 23, 2012

Last Update Posted:

Nov 1, 2016

Last Verified:

Oct 1, 2016

Keywords provided by University Health Network, Toronto

exercise therapy

rehabilitation

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 1, 2016