Clinical trial NCT02938000: E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors
Official title: E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: aerobic training
stroke
exercise
stroke recovery
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2016-10-19
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot study intends to evaluate an online exercise video rehabilitation program for stroke survivors with moderate disability compared to usual care. The intervention videos combine aerobic and resistance training using a latex resistance band, Thera band® elastic band, specifically designed for rehabilitation. This study will aim to show that for patients suffering acute ischemic stroke resulting in disability, at-home physical therapy with aerobic exercise videos will improve depression level and aerobic capacity more than usual care.

Detailed description: Seven million Americans are stroke survivors and another four million Americans are expected to have strokes by 2030.1 Nearly 800,000 strokes occur annually and of these, 25% occur after a previous stroke or transient ischemic attack (TIA).2 Put another way, stroke recurrence affects 30% of stroke survivors.3 Given the high burden of stroke among stroke survivors, preventing recurrence is a top priority for post-stroke and post-TIA management.

Stroke survivors must cope with impairments in functioning that can range from facial droops to hemiparesis and aphasia. These physical challenges mean that even four years after stroke, 71% of survivors feel they have not completely recovered from the stroke.4 The peak oxygen cost (VO2) of participating in activities of daily living such as walking is higher in stroke survivors six months after stroke than able-bodied individuals.5,6 This increased energy cost is related to decreased cardiorespiratory reserve, changes in tissue composition, and gait deviation and asymmetry.5,6 The exhaustion point for hemiparetic stroke survivors falls within the range of aerobic fitness required to perform activities of daily living (3-5 METS \[Metabolic Equivalents\]).6 Small increases in aerobic capacity would therefore translate into the ability to perform activities of daily living.6

The American Heart Association (AHA) and American Stroke Association issued guidelines in 2014 recommending physical activity and exercise to improve stroke survivors' functional ability, quality of life, and morbidity of stroke recurrence.3 It is the goal of this study to improve physical activity adherence in stroke survivors and thereby improve their cardiorespiratory reserve and reduce depression. Secondary variables to be examined include functional ability, balance, blood pressure, body mass index (BMI), rates of cerebrovascular and cardiovascular events, and mortality.

Exercise-based cardiac rehabilitation post-stroke or post-TIA Cardiac rehabilitation care post-discharge for stroke survivors is not established standard of practice. Several groups have been evaluating the efficacy of comprehensive cardiac rehabilitation, as provided to patients after acute MI, in post-stroke populations. This intervention has been shown to be cost effective in post-MI care, reducing healthcare cost overall (attributed to fewer re-admissions) and per quality-adjusted life year.12 Several groups have conducted small-scale trials of cardiac rehabilitation among TIA and stroke patients with promising improvements in cardiovascular fitness outcomes.13-16 Aerobic exercise for rehabilitation after stroke has been evaluated in small randomized controlled trials.6,17

One group conducted a randomized controlled trial of a comprehensive cardiac rehabilitation program in chronic stroke patients after ischemic events.14 Their intervention was twice weekly, supervised exercise on cycle ergometers (upper or lower body) to 50-60% maximal heart rate.14 At the end of the ten-week program, subjects in the intervention arm showed significant improvements in cardiovascular fitness as measured by peak oxygen consumption (VO2) and rating of perceived exertion (RPE) after three minutes of exercise.14 Self-reported depression and anxiety scores also improved in the intervention arm, though health-related quality of life did not.14 The same group is now conducting a larger clinical trial called Cardiac Rehabilitation Adapted For Transient Ischemic Attack and Stroke (CRAFTS) expanding on the results of the earlier pilot.13,14

Another group in London, Ontario conducted a feasibility study evaluating the use of comprehensive cardiac rehabilitation (CCR) in patients within 12 months of TIA or mild, non-disabling stroke.15 In this prospective cohort study, 100 patients were enrolled and 80 patients completed the CCR with group-based or home-based progressive aerobic training for six months.15 Diet counseling in individual or group-based sessions emphasized the Mediterranean diet.15 Patients were screened for depression and referred to a psychologist for anxiety, depression, and smoking cessation as needed.15 Medications were optimized to meet AHA recommendations regarding use of aspirin or anti-platelet agent, angiotensin converting enzyme inhibitor, statin, and blood pressure management with diuretic.15 The results of the feasibility study were promising with improvements in cardiopulmonary fitness, blood lipid profile, BMI, weight, waist circumference, smoking status, and Duke Treadmill Score.15 Although the study was not powered to evaluate morbidity of stroke/TIA and mortality, the recurrence of stroke was 0% among patients who completed intake/outtake and 4.6% including patients who left CCR.15

A third study, PREVENT, is a randomized controlled trial out of Nova Scotia, Canada currently enrolling patients post-TIA or non-disabling stroke to evaluate a program of rehabilitative exercise and education in improving risk factors.16 The trial aims to randomize 250 patients to control (usual care) or to a 12-week comprehensive rehabilitation program comprising group- and home-based exercise with aerobic and resistance training and weekly education classes.16 Primary outcomes to be measured include lipid profile, blood pressure, waist circumference, fasting glucose, and hemoglobin A1c; secondary outcomes to be assessed are exercise capacity, walking endurance, cognitive function, depression, health-related quality of life, and physical activity.16 The trial was not powered to evaluate the effectiveness of the intervention in preventing morbidity of stroke/TIA/cardiac events.16

AHA Recommendation In 2014, American Heart Association (AHA)/American Stroke Association released recommendations regarding physical activity in stroke survivors.3 Prior to starting, a pre-exercise physical evaluation including electrocardiogram (ECG), heart rate monitoring, and graded exercise testing. Recommended exercise is aerobic cardiovascular exercise 3-5 times weekly for 20-60 minutes; aerobic activity should achieve 40-70% peak O2 or heart rate maximum.3 Additional exercise in resistance training two to three days weekly is also recommended.

The proposed intervention differs from these studies in that it involves a one-way communication via streaming video in addition to case management follow-up phone calls. To our knowledge, the efficacy of this tele-intervention has not been reported previously.

Thera-band® elastic bands Thera band® elastic bands (The Hygienic Corporation, Akron, Ohio) are versatile exercise training tools used primarily to provide graded resistance during strength training.22 They have been used in home-based resistance training for stroke rehabilitation with improvement in strength, gait speed, and functional ability.22 Combined with aerobic activity, strength training of hip flexors, extensors, and abductors improved gait speeds between 3.6-12.6 meters/minute in ambulatory stroke survivors after ten weeks of intervention.22-24 A small study (sponsored by the manufacturer of Thera band®) found using Thera band® elastic band is comparable to using resistance-training machines in activating exercised muscles, as demonstrated by electromyography (EMG).25 Community-based training with physiotherapists guiding stroke survivors in the use of Thera band® elastic bands for resistance training over 16 weeks improves balance and strength.26

In addition to providing resistance, Thera band® can be used to assist stroke survivors in dorsiflexion during gait training. Patients who received gait training using Thera band® showed faster improvement in mobility than usual care.27

A guided, community-based model is the most representative of e-rehabilitation. Strength and gait improvements are comparable in supervised and unsupervised resistance training in stroke survivors.23 This study's recorded exercise videos are intended to visually demonstrate aerobic resistance training to community-dwelling patients. Although the patients will remain unsupervised, exercise sessions will be entirely guided by a trained exercise physiologist.

This pilot, randomized, controlled, double-blinded study will compare a comprehensive lifestyle and exercise rehabilitation intervention to usual care in patients after acute stroke. The investigators of this study intend to evaluate an online exercise video rehabilitation program for stroke survivors with moderate disability compared to usual care. The intervention videos combine aerobic and resistance training using a latex resistance band, Thera band® elastic band, specifically designed for rehabilitation.

The proposed study will be performed at the Kaiser Permanente (KP) San Diego Medical Center. Kaiser Permanente patients that are admitted with acute ischemic stroke, resulting in moderate disability, in the prior two weeks to enrollment range will be recruited in the medical center. Patients will be directly offered participation in the study by the principal investigator, at the time of hospital admission to the KP San Diego Medical Center with ischemic stroke. For patients interested in participating in the trial, screening based on written inclusion and exclusion criteria will be done by reviewing patient information in the electronic medical record system. If patient meets initial eligibility criteria, they will be notified by telephone.

As part of usual care, all enrolled patients will have an initial study visit included within their post-hospital discharge follow-up visit. Informed consent will be obtained at this time, as well as subsequent collection of baseline data, including vital signs, social and medical history, demographic variables, and questionnaire response items.

All patients will have an appointment at Positive Choice within two weeks of the initial visit for education training, further testing (aerobic capacity measures), and distribution of Thera bands to the intervention group. Within the subsequent week patients and family in the intervention arm will receive an educational outreach call which will include medication reconciliation and adherence, dietary adjustments, smoking cessation, physical activity, depression education, as well as how to access the physical therapy videos online. Videos are 20-30 minutes with combination of aerobic and resistance training to be done in seated positions.

Study staff will call patients 1 week after the aforementioned educational phone call to offer encouragement, ask about progress, and answer any questions the patient may have regarding the videos. To control patients, the call will be a brief reminder to continue to adhere to medical therapy. Study staff will also call all enrolled patients to screen for depression at 4-week intervals, and to ensure coordination for depression treatment with primary care physician. Investigator will perform physical exam including NIH stroke scale at the completion of prescribed therapy. At this time, patient will be advised to continue physical activity with videos as part of AHA recommendation.

The outcome status (in terms of toxicity, response, reason off study, progression, and survival) of all eligible patients will be reported. All eligible patients who begin treatment will be included in the analysis of survival and time-to-failure. The primary outcomes of this study are the impact on the depression scores and cardiorespiratory reserve change of stroke survivors as a result of the intervention videos combined with aerobic and resistance training using a latex resistance bands. Additional outcomes of this study are measurement of potential changes in body mass index (BMI), blood pressure (BP), hemoglobin A1c (HbA1c), functional status, balance, incidence of cardiovascular and cerebrovascular events, as well as adherence to exercise program.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke within 2 weeks of enrollment

Exclusion Criteria:

* unstable coronary artery disease, oxygen dependent, with oxygen saturation less than 92% on room air, unable to perform peak oxygen consumption testing, musculoskeletal disease limiting exercise performance.

Primary outcomes:
measure: VO2: aerobic capacity measurement with peak VO2 using 6 minute walk test
timeFrame: 12 weeks
Secondary outcomes:
measure: Berg Balance Score
timeFrame: 12 weeks
measure: adherence to exercise program, interventional group only
timeFrame: 12 weeks
measure: Patient Health Questionnaire - 9 (PHQ 9)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
Study officials:
affiliation: Kaiser Permanente
name: William P Neil, MD
role: PRINCIPAL_INVESTIGATOR
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