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

Cerebrovascular Accident Clinical Trial

— TRI-RAvA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712724
• Other study ID #: OSN1207-000144
• Secondary ID: OSN1207-000144
• Status: Completed
• Phase: N/A
• First received: October 20, 2012
• Last updated: October 31, 2016
• Start date: March 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto Rehabilitation Institute	Toronto	Ontario

Sponsors (3)

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

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Vascular Cognitive Impairment Harmonization Standards	1 year	No
Secondary	Body Composition	Fat free mass will be measured by dual energy x-ray absorptiometry	1 year	No
Secondary	Biochemical Changes (blood samples)	brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein	1 year	No
Secondary	Functional Mobility	Six minute walk distance	1 year	No