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CompletedNCT02494518Updated Mar 28, 2019Results posted

Forced Aerobic Exercise for Stroke Rehabilitation

An interventional study of Forced Exercise & Upper Extremity Repetitive Task Practice and Voluntary Exercise & Upper Extremity Repetitive Task Practice in Stroke, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-03-28.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.

Read the detailed description

The goal of this study is to determine the potential for forced aerobic exercise to augment the recovery of motor function in individuals with stroke. Current approaches to stroke rehabilitation involve intensive, therapist-directed task practice that is both expensive and in some cases, ineffective in fostering functional neuromotor recovery. The identification of a safe, cost-effective approach, such as forced aerobic exercise, to augment the recovery of function achieved through task practice while simultaneously decreasing the cardiovascular risk factors prevalent in stroke survivors would be significant to rehabilitation and stroke communities.

Animal studies along with preliminary human data indicate a specific type of aerobic exercise (AE), forced aerobic exercise (FE), may be ideal in facilitating motor recovery associated with repetitive task practice (RTP). The hypothesis is that that deficits in afferent input and motor cortical output following stroke prevents patients from achieving and maintaining an exercise intensity that is sufficient for facilitating motor recovery; therefore, FE is needed to augment their voluntary efforts and achieve greater gains in recovery. In previous research, a safe lower extremity FE intervention was initially applied to individuals with Parkinson's disease and subsequently to individuals with stroke. Preliminary results indicate that those completing an 8-week FE intervention paired with an abbreviated session of RTP exhibited significantly greater improvement in Fugl-Meyer scores at end of treatment despite completing 40% fewer RTP repetitions, compared to those receiving voluntary-rate aerobic exercise (VE) and RTP and time-matched RTP only. Improvements in cardiovascular fitness and lower extremity motor function were also evident in both groups that engaged in aerobic exercise (FE and VE). Positive results from a preliminary trial indicate safety, feasibility, and initial efficacy of combining two modes of aerobic exercise training with RTP provide rationale for a systematic and larger scale trial to determine the precise role of aerobic exercise, forced and voluntary, in facilitating motor recovery following stroke.

For this study, 30 individuals with chronic stroke will be randomized into one of the following groups: FE = RTP, VE + RTP or patient education and RTP. All three groups will receive an identical dose of contact time over 8 weeks (3X per week). An intervention group receiving a 45-minute session of patient education paired with RTP will serve as the non-exercise control. Clinical and biomechanical outcomes measuring change in upper extremity motor function, lower extremity motor function, and cardiovascular fitness will provide the most complete picture, to date, on the potential neurologic effects of AE (forced and voluntary) on motor recovery and brain function in humans with stroke.

02

Conditions studied

  • Stroke

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Keywords

  • stroke
  • aerobic exercise
  • forced exercise
  • repetitive task practice
  • arm function
  • upper extremity
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Able to provide informed consent
  • At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging
  • Fugl-Meyer Motor Score 19-55 in involved upper extremity
  • Approval from patient's physician
  • Age between 18 and 85 years

Exclusion criteria

Exclusion Criteria:

  • Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
  • Serious cardiac arrhythmia
  • Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)
  • Other medical or musculoskeletal contraindication to exercise
  • Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
  • Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
  • Pregnancy
  • Unstable blood pressure at rest or with exercise
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Forced Exercise & Upper Extremity Repetitive Task Practice

    Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises

    Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice

  • Active comparator
    Voluntary Exercise & Upper Extremity Repetitive Task Practice

    Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises

    Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice

  • Active comparator
    Stroke Education & Upper Extremity Repetitive Task Practice

    Participants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises

    Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice

Interventions

  • BehavioralForced Exercise & Upper Extremity Repetitive Task Practice
  • BehavioralVoluntary Exercise & Upper Extremity Repetitive Task Practice
  • BehavioralStroke Education & Upper Extremity Repetitive Task Practice
06

What researchers measure

Primary outcomes

  1. Fugl Meyer Assessment

    Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.

    Time frame: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends

  2. Wolf Motor Function Test

    Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  3. Stroke Impact Scale

    Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  4. Metabolic Stress Test

    Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

    Time frame: Change from baseline to follow up assessments at end of 8 week intervention

Secondary outcomes

  1. Action Research Arm Test

    Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  2. Center for Epidemiological Studies-Depression

    Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  3. Processing Speed Test

    Matching letters and symbols to test cognition. The reported data is change in total number correct.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  4. Nine Hole Peg Test

    Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  5. Six Minute Walk Test

    Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.

    Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

07

Results

Posted Mar 28, 2019

Participant flow

Participant flow — Overall Study
MilestoneForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Started111211
Completed10108
Not completed123

Outcome measures

PrimaryFugl Meyer Assessment

Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.

Time frame:
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · units on a scale
Fugl Meyer Assessment
units on a scaleForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to Midpoint6.90 ± 5.554.00 ± 3.276.25 ± 3.65
Baseline to EOT10.10 ± 5.326.50 ± 3.478.88 ± 4.76
Baseline to EOT+411.11 ± 5.697.10 ± 4.519.25 ± 5.75
PrimaryWolf Motor Function Test

Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · units on a scale
Wolf Motor Function Test
units on a scaleForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT7.80 ± 6.096.40 ± 3.1710.50 ± 6.87
Baseline to EOT+49.22 ± 6.679.60 ± 2.5910.88 ± 6.77
PrimaryStroke Impact Scale

Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · units on a scale
Stroke Impact Scale
units on a scaleForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT15.00 ± 11.5514.50 ± 14.039.38 ± 12.08
Baseline to EOT+419.44 ± 12.1014.00 ± 20.2521.25 ± 19.04
PrimaryMetabolic Stress Test

Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

Time frame:
Change from baseline to follow up assessments at end of 8 week intervention
Reported as:
Mean · mL/kg/min
Metabolic Stress Test
mL/kg/minForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Metabolic Stress Test0.02 ± 1.351.09 ± 1.700.40 ± 0.70
SecondaryAction Research Arm Test

Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · units on a scale
Action Research Arm Test
units on a scaleForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT8.60 ± 6.246.30 ± 4.836.38 ± 4.96
Baseline to EOT+48.56 ± 4.987.50 ± 5.507.13 ± 4.52
SecondaryCenter for Epidemiological Studies-Depression

Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · units on a scale
Center for Epidemiological Studies-Depression
units on a scaleForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT-5.20 ± 7.44-0.30 ± 8.31-2.00 ± 5.53
Baseline to EOT+4-3.67 ± 6.63-2.60 ± 5.46-3.75 ± 7.21
SecondaryProcessing Speed Test

Matching letters and symbols to test cognition. The reported data is change in total number correct.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · number correct
Processing Speed Test
number correctForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT0.90 ± 4.681.88 ± 4.222.71 ± 6.32
Baseline to EOT+42.89 ± 7.523.25 ± 5.156.38 ± 10.27
SecondaryNine Hole Peg Test

Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · seconds
Nine Hole Peg Test
secondsForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT-8.07 ± 15.71-16.15 ± 45.64-19.35 ± 21.51
Baseline to EOT+4-8.10 ± 10.58-7.81 ± 34.89-29.15 ± 32.75
SecondarySix Minute Walk Test

Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.

Time frame:
Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Reported as:
Mean · feet
Six Minute Walk Test
feetForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Baseline to EOT133.20 ± 107.78188.70 ± 155.22-21.75 ± 111.76
Baseline to EOT+478.50 ± 224.32127.70 ± 190.0578.88 ± 202.38

Adverse events

Collected over 12 weeks from baseline assessment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Forced Exercise & Upper Extremity Repetitive Task Practice0/11 (0%)0/11 (0%)1/11 (9.1%)
Voluntary Exercise & Upper Extremity Repetitive Task Practice0/12 (0%)0/12 (0%)0/12 (0%)
Stroke Education & Upper Extremity Repetitive Task Practice0/11 (0%)1/11 (9.1%)0/11 (0%)
Most frequent serious events
Most frequent serious events
EventForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
FallGeneral disorders0/110/121/11
Most frequent other events
Most frequent other events
EventForced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task Practice
Skin IntegritySkin and subcutaneous tissue disorders1/110/120/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
<=18 years0000
Between 18 and 65 years87621
>=65 years35513
Age, Continuous
Age, Continuous(years)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
Mean54.91 ± 10.6959.33 ± 13.8460.45 ± 11.2558.26 ± 11.94
Sex: Female, Male
Sex: Female, Male(Participants)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
Female46313
Male76821
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
Hispanic or Latino1113
Not Hispanic or Latino10111031
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
American Indian or Alaska Native0000
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American63615
White37313
More than one race0000
Unknown or Not Reported2125
Region of Enrollment
Region of Enrollment(participants)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
United States11121134
Fugl-Meyer Assessment
Fugl-Meyer Assessment(units on a scale)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
Mean35.73 ± 8.7135.92 ± 10.1132.09 ± 7.4434.62 ± 8.77
Wolf Motor Function Test
Wolf Motor Function Test(units on a scale)Forced Exercise & Upper Extremity Repetitive Task PracticeVoluntary Exercise & Upper Extremity Repetitive Task PracticeStroke Education & Upper Extremity Repetitive Task PracticeTotal
Mean55.09 ± 12.1952.83 ± 9.4951.91 ± 8.7953.26 ± 10.02

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
09

References and documents

Publications

  • Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9. PubMed 32918907 ↗
  • Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25. PubMed 31778659 ↗
  • Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10. PubMed 30543801 ↗

Study documents

  • Protocol and statistical analysis plan · Apr 25, 2012

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02494518
Lead sponsor
The Cleveland Clinic
Collaborators
American Heart Association
Responsible party
Susan Linder (Research Physical Therapist, The Cleveland Clinic) — Principal investigator
First posted
Jul 10, 2015
Start date
Jul 2015
Primary completion
Aug 2017
Completion
Aug 2017
Results posted
Mar 28, 2019
Last update
Mar 28, 2019

Study contacts

Susan Linder, PT, DPT, NCS
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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