Forced Aerobic Exercise for Stroke Rehabilitation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02494518

Enrollment

Registered

2015-07-10

Start date

2015-07-31

Completion date

2017-08-31

Last updated

2019-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, aerobic exercise, forced exercise, repetitive task practice, arm function, upper extremity

Brief 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.

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.

Interventions

BEHAVIORALForced Exercise & Upper Extremity Repetitive Task Practice

BEHAVIORALVoluntary Exercise & Upper Extremity Repetitive Task Practice

BEHAVIORALStroke Education & Upper Extremity Repetitive Task Practice

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

Measure	Time frame	Description
Fugl Meyer Assessment	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	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	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	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.

Secondary

Measure	Time frame	Description
Action Research Arm Test	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 change in total score. Scores range from 0-57, and higher scores indicate better function.
Six Minute Walk Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Center for Epidemiological Studies-Depression	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Processing Speed Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Matching letters and symbols to test cognition. The reported data is change in total number correct.
Nine Hole Peg Test	Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends	Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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 Forced Exercise & Upper Extremity Repetitive Task Practice	11
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 Voluntary Exercise & Upper Extremity Repetitive Task Practice	12
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 Stroke Education & Upper Extremity Repetitive Task Practice	11
Total	34

Baseline characteristics

Characteristic	Voluntary Exercise & Upper Extremity Repetitive Task Practice	Total	Forced Exercise & Upper Extremity Repetitive Task Practice	Stroke Education & Upper Extremity Repetitive Task Practice
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	5 Participants	13 Participants	3 Participants	5 Participants
Age, Categorical Between 18 and 65 years	7 Participants	21 Participants	8 Participants	6 Participants
Age, Continuous	59.33 years STANDARD_DEVIATION 13.84	58.26 years STANDARD_DEVIATION 11.94	54.91 years STANDARD_DEVIATION 10.69	60.45 years STANDARD_DEVIATION 11.25
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	3 Participants	1 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants	31 Participants	10 Participants	10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Fugl-Meyer Assessment	35.92 units on a scale STANDARD_DEVIATION 10.11	34.62 units on a scale STANDARD_DEVIATION 8.77	35.73 units on a scale STANDARD_DEVIATION 8.71	32.09 units on a scale STANDARD_DEVIATION 7.44
Metabolic Stress Test	16.72 mL/kg/min STANDARD_DEVIATION 4.06	15.54 mL/kg/min STANDARD_DEVIATION 3.81	15.23 mL/kg/min STANDARD_DEVIATION 3.84	14.58 mL/kg/min STANDARD_DEVIATION 3.48
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	3 Participants	15 Participants	6 Participants	6 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	5 Participants	2 Participants	2 Participants
Race (NIH/OMB) White	7 Participants	13 Participants	3 Participants	3 Participants
Region of Enrollment United States	12 participants	34 participants	11 participants	11 participants
Sex: Female, Male Female	6 Participants	13 Participants	4 Participants	3 Participants
Sex: Female, Male Male	6 Participants	21 Participants	7 Participants	8 Participants
Stroke Impact Scale	51.67 units on a scale STANDARD_DEVIATION 18.13	53.09 units on a scale STANDARD_DEVIATION 20.04	53.64 units on a scale STANDARD_DEVIATION 23.46	54.09 units on a scale STANDARD_DEVIATION 20.23
Wolf Motor Function Test	52.83 units on a scale STANDARD_DEVIATION 9.49	53.26 units on a scale STANDARD_DEVIATION 10.02	55.09 units on a scale STANDARD_DEVIATION 12.19	51.91 units on a scale STANDARD_DEVIATION 8.79

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 11	0 / 12	0 / 11
other Total, other adverse events	1 / 11	0 / 12	0 / 11
serious Total, serious adverse events	0 / 11	0 / 12	1 / 11

Outcome results

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.

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

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Forced Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to Midpoint	6.90 units on a scale	Standard Deviation 5.55
Forced Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT+4	11.11 units on a scale	Standard Deviation 5.69
Forced Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT	10.10 units on a scale	Standard Deviation 5.32
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT	6.50 units on a scale	Standard Deviation 3.47
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT+4	7.10 units on a scale	Standard Deviation 4.51
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to Midpoint	4.00 units on a scale	Standard Deviation 3.27
Stroke Education & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT+4	9.25 units on a scale	Standard Deviation 5.75
Stroke Education & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to EOT	8.88 units on a scale	Standard Deviation 4.76
Stroke Education & Upper Extremity Repetitive Task Practice	Fugl Meyer Assessment	Baseline to Midpoint	6.25 units on a scale	Standard Deviation 3.65

Primary

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

Arm	Measure	Value (MEAN)	Dispersion
Forced Exercise & Upper Extremity Repetitive Task Practice	Metabolic Stress Test	0.02 mL/kg/min	Standard Error 1.35
Voluntary Exercise & Upper Extremity Repetitive Task Practice	Metabolic Stress Test	1.09 mL/kg/min	Standard Error 1.7
Stroke Education & Upper Extremity Repetitive Task Practice	Metabolic Stress Test	0.40 mL/kg/min	Standard Error 0.7

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.