E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors

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.