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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University Health Network, Toronto
Sponsor:
Collaborator:
Sunnybrook Research Institute
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01712724
First received: October 20, 2012
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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 Intervention
Cerebrovascular Accident
Other: combined resistance and aerobic training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Vascular Cognitive Impairment Harmonization Standards


Secondary Outcome Measures:
  • Structural Brain Changes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    grey matter and hippocampal volumes

  • Body Composition [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Fat free mass will be measured by dual energy x-ray absorptiometry

  • Biochemical Changes (blood samples) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein

  • Functional Mobility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Six minute walk distance


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, structural brain changes (grey matter, hippocampal, volumes), cerebral perfusion (arterial spin labeling), 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712724

Contacts
Contact: Susan Marzolini, MSc 416-597-3422 ext 5246 susan.marzolini@uhn.ca

Locations
Canada, Ontario
Toronto Rehabilitation Institute Not yet recruiting
Toronto, Ontario, Canada, M5R 1G7
Contact: Susan Marzolini, MSc    416-597-3422 ext 5246    susan.marzolini@uhn.ca   
Principal Investigator: Susan Marzolini, MSc         
Principal Investigator: Dina Brooks, PhD         
Principal Investigator: Paul I Oh, MD         
Principal Investigator: Dale Corbett, PhD         
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Research Institute
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01712724     History of Changes
Other Study ID Numbers: OSN1207-000144, OSN1207-000144
Study First Received: October 20, 2012
Last Updated: October 23, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University Health Network, Toronto:
exercise therapy
rehabilitation

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014