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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
combined resistance and aerobic training
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring exercise therapy, rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aerobic Training

Combined Resistance and Aerobic Training

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Cognitive function
Vascular Cognitive Impairment Harmonization Standards

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2012
Last Updated
October 31, 2016
Sponsor
University Health Network, Toronto
Collaborators
Heart and Stroke Foundation of Canada, Ontario Stroke Network
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1. Study Identification

Unique Protocol Identification Number
NCT01712724
Brief Title
Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke
Acronym
TRI-RAvA
Official Title
Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Heart and Stroke Foundation of Canada, Ontario Stroke Network

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
exercise therapy, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Combined Resistance and Aerobic Training
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
combined resistance and aerobic training
Intervention Description
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 Outcome Measure Information:
Title
Cognitive function
Description
Vascular Cognitive Impairment Harmonization Standards
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Body Composition
Description
Fat free mass will be measured by dual energy x-ray absorptiometry
Time Frame
1 year
Title
Biochemical Changes (blood samples)
Description
brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein
Time Frame
1 year
Title
Functional Mobility
Description
Six minute walk distance
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5R 1G7
Country
Canada

12. IPD Sharing Statement

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

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