Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Forced Exercise & Upper Extremity Repetitive Task Practice | Active Comparator | Participants will perform the following:
|
|
| Voluntary Exercise & Upper Extremity Repetitive Task Practice | Active Comparator | Participants will perform the following:
|
|
| Stroke Education & Upper Extremity Repetitive Task Practice | Active Comparator | Participants will perform the following:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forced Exercise & Upper Extremity Repetitive Task Practice | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Change from baseline to follow up assessments at end of 8 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
| Center for Epidemiological Studies-Depression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Linder, PT, DPT, NCS | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32918907 | Derived | 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. | |
| 31778659 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Forced Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Forced Exercise & Upper Extremity Repetitive Task Practice |
| FG001 | Voluntary Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Voluntary Exercise & Upper Extremity Repetitive Task Practice |
| FG002 | Stroke Education & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Stroke Education & Upper Extremity Repetitive Task Practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Forced Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Forced Exercise & Upper Extremity Repetitive Task Practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends |
|
12 weeks from baseline assessment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Forced Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Forced Exercise & Upper Extremity Repetitive Task Practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | General disorders | Non-systematic Assessment | One participant fell during 6MWT administration, resulting in superficial injuries that did not require follow up care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Integrity | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One participant developed a blister after forced exercise. The blister was monitored and did not require follow up care. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Linder | Cleveland Clinic | (216) 445-9815 | linders@ccf.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 25, 2012 | Jun 8, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Voluntary Exercise & Upper Extremity Repetitive Task Practice |
| Behavioral |
|
| Stroke Education & Upper Extremity Repetitive Task Practice | Behavioral |
|
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression. |
| 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. | 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. | 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. | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
| 30543801 | Derived | 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. |
| BG001 | Voluntary Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Voluntary Exercise & Upper Extremity Repetitive Task Practice |
| BG002 | Stroke Education & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Stroke Education & Upper Extremity Repetitive Task Practice |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fugl-Meyer Assessment | Motor test to assess arm impairment. Scores range from 0-66 and higher scores represent less impairment. | Mean | Standard Deviation | units on a scale |
|
| Wolf Motor Function Test | Motor test to assess arm function. The reported data is the total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function. | Mean | Standard Deviation | units on a scale |
|
| 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. | Mean | Standard Deviation | units on a scale |
|
| Metabolic Stress Test | Cycling test to measure cardiovascular fitness. The data reported is VO2peak. Higher scores indicate higher aerobic capacities. | Mean | Standard Deviation | mL/kg/min |
|
| OG001 | Voluntary Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Voluntary Exercise & Upper Extremity Repetitive Task Practice |
| OG002 | Stroke Education & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Stroke Education & Upper Extremity Repetitive Task Practice |
|
|
| Primary | 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. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Primary | 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. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Primary | Metabolic Stress Test | Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities. | Posted | Mean | Standard Error | mL/kg/min | Change from baseline to follow up assessments at end of 8 week intervention |
|
|
|
| Secondary | 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. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Secondary | 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. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | units on a scale | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Secondary | Processing Speed Test | Matching letters and symbols to test cognition. The reported data is change in total number correct. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4 | Posted | Mean | Standard Deviation | number correct | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Secondary | Nine Hole Peg Test | Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete. | One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4. One individual in VE+RTP did not complete the NHPT at EOT+4. | Posted | Mean | Standard Deviation | seconds | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| Secondary | Six Minute Walk Test | Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled. | Two individuals in FE+RTP did not complete this assessment at EOT+4 | Posted | Mean | Standard Deviation | feet | Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 1 |
| 11 |
| EG001 | Voluntary Exercise & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Voluntary Exercise & Upper Extremity Repetitive Task Practice | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Stroke Education & Upper Extremity Repetitive Task Practice | Participants will perform the following:
Stroke Education & Upper Extremity Repetitive Task Practice | 0 | 11 | 1 | 11 | 0 | 11 |
|
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|
| Baseline to EOT+4 |
|
|