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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Other: combined resistance and aerobic training

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5R 1G7
      • Toronto Rehabilitation Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function	Vascular Cognitive Impairment Harmonization Standards	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Heart and Stroke Foundation of Canada; Ontario Stroke Network

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 20, 2012
• First Submitted That Met QC Criteria: October 20, 2012
• First Posted (Estimate): October 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 1, 2016
• Last Update Submitted That Met QC Criteria: October 31, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: rehabilitation; exercise therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: OSN1207-000144 (Other Grant/Funding Number: OSN1207-000144)