StrokeNCT02494518

Forced Aerobic Exercise for Stroke Rehabilitation

A study testing Forced Exercise & Upper Extremity Repetitive Task Practice, Voluntary Exercise & Upper Extremity Repetitive Task Practice and Stroke Education & Upper Extremity Repetitive Task Practice in people with Stroke, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Stroke
What is being tested?: Forced Exercise & Upper Extremity Repetitive Task Practice, Voluntary Exercise & Upper Extremity Repetitive Task Practice and Stroke Education & Upper Extremity Repetitive Task Practice
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Conditions: Stroke
Being tested: Forced Exercise & Upper Extremity Repetitive Task Practice, Voluntary Exercise & Upper Extremity Repetitive Task Practice, Stroke Education & Upper Extremity Repetitive Task Practice
Keywords: stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Forced Exercise & Upper Extremity Repetitive Task PracticeBehavioural
Voluntary Exercise & Upper Extremity Repetitive Task PracticeBehavioural
Stroke Education & Upper Extremity Repetitive Task PracticeBehavioural

Study groups in NCT02494518
Study group	Role	What they receive
Forced Exercise & Upper Extremity Repetitive Task Practice	Active comparator	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 Receives: Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Active comparator	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 Receives: Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice
Stroke Education & Upper Extremity Repetitive Task Practice	Active comparator	Participants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises Receives: Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
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.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Metabolic Stress Test
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Measured: Change from baseline to follow up assessments at end of 8 week intervention

Secondary outcomes (5)

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.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Processing Speed Test
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Nine Hole Peg Test
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Six Minute Walk Test
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Measured: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Aug 2017

First posted10 Jul 2015 (estimated)
Study startJul 2015
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02494518
Sponsor's protocol ID: 12-402
Status last verified: Dec 2018
First submitted: 6 Jul 2015
Last updated: 28 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Forced Aerobic Exercise for Stroke Rehabilitation
ClinicalTrials.gov ID: NCT02494518
Acronym / sponsor ID: 12-402
Conditions: Stroke
Keywords: stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Collaborators: American Heart Association
Study start: Jul 2015
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 10 Jul 2015 (estimated)
Results: Posted 28 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Forced Exercise & Upper Extremity Repetitive Task Practice	Active comparator	Behavioral: Forced Exercise & Upper Extremity Repetitive Task PracticeParticipants 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
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Active comparator	Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task PracticeParticipants 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
Stroke Education & Upper Extremity Repetitive Task Practice	Active comparator	Behavioral: Stroke Education & Upper Extremity Repetitive Task PracticeParticipants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

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
Forced Exercise & Upper Extremity Repetitive Task Practice	Behavioural	Forced Exercise & Upper Extremity Repetitive Task Practice
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Behavioural	Voluntary Exercise & Upper Extremity Repetitive Task Practice
Stroke Education & Upper Extremity Repetitive Task Practice	Behavioural	Stroke Education & Upper Extremity Repetitive Task Practice

Primary outcome

Fugl Meyer Assessment
Time frame: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
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.
Wolf Motor Function Test
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Stroke Impact Scale
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
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.
Metabolic Stress Test
Time frame: Change from baseline to follow up assessments at end of 8 week intervention
Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

5 secondary outcomes

Action Research Arm Test
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Center for Epidemiological Studies-Depression
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Processing Speed Test
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Nine Hole Peg Test
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends
Six Minute Walk Test
Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

Results and safety

Results posted to the registry on 28 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Forced Exercise & Upper Extremity Repetitive Task Practice	11	10
Voluntary Exercise & Upper Extremity Repetitive Task Practice	12	10
Stroke Education & Upper Extremity Repetitive Task Practice	11	8

Primary outcome: Fugl Meyer Assessment

Time frame: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends. Mean (Standard Deviation). Unit: units on a scale

Measure	Forced Exercise & Upper Extremity Repetitive Task Practice n = 10	Voluntary Exercise & Upper Extremity Repetitive Task Practice n = 10	Stroke Education & Upper Extremity Repetitive Task Practice n = 8
Baseline to Midpoint	6.90 (5.55)	4.00 (3.27)	6.25 (3.65)
Baseline to EOT	10.10 (5.32)	6.50 (3.47)	8.88 (4.76)
Baseline to EOT+4	11.11 (5.69)	7.10 (4.51)	9.25 (5.75)

Population analysed: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4

Primary outcome: Wolf Motor Function Test

Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends. Mean (Standard Deviation). Unit: units on a scale

Measure	Forced Exercise & Upper Extremity Repetitive Task Practice n = 10	Voluntary Exercise & Upper Extremity Repetitive Task Practice n = 10	Stroke Education & Upper Extremity Repetitive Task Practice n = 8
Baseline to EOT	7.80 (6.09)	6.40 (3.17)	10.50 (6.87)
Baseline to EOT+4	9.22 (6.67)	9.60 (2.59)	10.88 (6.77)

Population analysed: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4

Primary outcome: Stroke Impact Scale

Time frame: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends. Mean (Standard Deviation). Unit: units on a scale

Measure	Forced Exercise & Upper Extremity Repetitive Task Practice n = 10	Voluntary Exercise & Upper Extremity Repetitive Task Practice n = 10	Stroke Education & Upper Extremity Repetitive Task Practice n = 8
Baseline to EOT	15.00 (11.55)	14.50 (14.03)	9.38 (12.08)
Baseline to EOT+4	19.44 (12.10)	14.00 (20.25)	21.25 (19.04)

Population analysed: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4

Primary outcome: Metabolic Stress Test

Time frame: Change from baseline to follow up assessments at end of 8 week intervention. Mean (Standard Error). Unit: mL/kg/min

Measure	Forced Exercise & Upper Extremity Repetitive Task Practice n = 10	Voluntary Exercise & Upper Extremity Repetitive Task Practice n = 9	Stroke Education & Upper Extremity Repetitive Task Practice n = 8
Value	0.02 (1.35)	1.09 (1.70)	0.40 (0.70)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks from baseline assessment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Forced Exercise & Upper Extremity Repetitive Task Practice	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Voluntary Exercise & Upper Extremity Repetitive Task Practice	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Stroke Education & Upper Extremity Repetitive Task Practice	1 of 11 (9.1%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32918907Linder 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.
Derived from this study: PubMed 31778659Linder 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.
Derived from this study: PubMed 30543801Rosenfeldt 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.

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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.

Susan Linder, PT, DPT, NCS principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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 28 Mar 2019. 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 United States. 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?

Yes. Results are posted in the registry (first posted 28 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Fugl Meyer Assessment (time frame: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends). The study lists 4 primary outcomes in all. 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 NCT02494518, which also lists 3 linked publications.

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 28 Mar 2019; AzTrials last refreshed its copy on 31 Oct 2026.