Forced Aerobic Exercise for Stroke Rehabilitation

NeuroTherapia, Inc.

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice; Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice; Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT02494518

12-402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

34 participants in 3 patient groups

Forced Exercise & Upper Extremity Repetitive Task Practice

Active Comparator group

Description:

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

Treatment:

Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice

Voluntary Exercise & Upper Extremity Repetitive Task Practice

Active Comparator group

Description:

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

Treatment:

Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice

Stroke Education & Upper Extremity Repetitive Task Practice

Active Comparator group

Description:

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

Treatment:

Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice