NCT01712724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

October 20, 2012

Last Update Submit

October 31, 2016

Conditions

Keywords

exercise therapyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    Vascular Cognitive Impairment Harmonization Standards

    1 year

Secondary Outcomes (3)

  • Body Composition

    1 year

  • Biochemical Changes (blood samples)

    1 year

  • Functional Mobility

    1 year

Study Arms (2)

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.

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

Other: combined resistance and aerobic training

Interventions

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.

Aerobic TrainingCombined Resistance and Aerobic Training

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute

Toronto, Ontario, M5R 1G7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2012

First Posted

October 23, 2012

Study Start

March 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations