E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors
E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors
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.
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.
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.