Cerebrovascular AccidentTRI-RAvANCT01712724
Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke
A study testing combined resistance and aerobic training in people with Cerebrovascular Accident, run by University Health Network, Toronto at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- combined resistance and aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Accident
- Being tested
- combined resistance and aerobic training
- Keywords
- exercise therapy, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined resistance and aerobic trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training | Active comparator | 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. Receives: Other: combined resistance and aerobic training |
| Combined Resistance and Aerobic Training | Experimental | 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 Receives: Other: combined resistance and aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Vascular Cognitive Impairment Harmonization Standards
Measured: 1 year
Secondary outcomes (3)
Body Composition
Fat free mass will be measured by dual energy x-ray absorptiometry
Measured: 1 year
Biochemical Changes (blood samples)
brain-derived neurotrophic factor, insulin-like growth factor I, homocysteine, and C-reactive protein
Measured: 1 year
Functional Mobility
Six minute walk distance
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startMar 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Ontario Stroke Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712724
- Sponsor's protocol ID
- OSN1207-000144
- Other IDs
- OSN1207-000144
- Acronym
- TRI-RAvA
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Vanzella LM, Lawand R, Shuaib M, Oh P, Corbett D, Marzolini S. Validity of Bioelectric Impedance in Relation to Dual-Energy X-Ray Absorptiometry for Measuring Baseline and Change in Body Composition After an Exercise Program in Stroke. J Strength Cond Res. 2022 Dec 1;36(12):3273-3279. doi: 10.1519/JSC.0000000000004287. Epub 2022 Jun 1.
PubMed 36417356
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Combined Resistance and Aerobic Training vs Aerobic Training on Cognition and Mobility Following Stroke
- ClinicalTrials.gov ID
- NCT01712724
- Acronym / sponsor ID
- TRI-RAvA / OSN1207-000144
- Conditions
- Cerebrovascular Accident
- Keywords
- exercise therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Ontario Stroke Network
- Study start
- Mar 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training | Active comparator | Other: combined resistance and aerobic trainingWalking, 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. |
| Combined Resistance and Aerobic Training | Experimental | Other: combined resistance and aerobic trainingThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined resistance and aerobic trainingFor 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. | Other | Aerobic Training, Combined Resistance and Aerobic Training |
Primary outcome
Cognitive function
Time frame: 1 year
Vascular Cognitive Impairment Harmonization Standards
3 secondary outcomes
Body Composition
Time frame: 1 year
Biochemical Changes (blood samples)
Time frame: 1 year
Functional Mobility
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Derived from this study: PubMed 36417356Vanzella LM, Lawand R, Shuaib M, Oh P, Corbett D, Marzolini S. Validity of Bioelectric Impedance in Relation to Dual-Energy X-Ray Absorptiometry for Measuring Baseline and Change in Body Composition After an Exercise Program in Stroke. J Strength Cond Res. 2022 Dec 1;36(12):3273-3279. doi: 10.1519/JSC.0000000000004287. Epub 2022 Jun 1.
Related trials for Cerebrovascular Accident
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined resistance and aerobic training in people with Cerebrovascular Accident, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.