The Stroke and Exercise Program

Stroke recently declined from the third to the fifth leading cause of death in the United
States. However, Stroke remains the leading cause of long-term disability and is among the
most expensive chronic diseases, costing the US approximately 34 billion dollars per year.
The decrease in stroke-related mortality has led to an increase in stroke survivors, and it
is estimated that the overall prevalence will increase by 25% by 2030 to a record 11 million
stroke survivors. Importantly, two-thirds of the nearly one million Americans experiencing
ischemic stroke or transient ischemic attack (TIA) will regain functional independence. In
these patients, engagement in habitual purposeful physical activity (PA) is a powerful means
of secondary stroke prevention.

Habitual PA can improve several other important health indicators in stroke survivors,
including cardiorespiratory fitness, functional independence, gait stability, overall
vascular health, and cognition, while also reducing the risk for falls, cardiometabolic
disease, and adverse recurrent events. Consequently, the American Heart Association/American
Stroke Association (AHA/ASA) recommends patients who have survived a stroke and regained
functional independence both increase PA and reduce sedentary behaviors (SB). However, these
recommendations are not always prescribed, and when they are prescribed, patient compliance
is often poor. Recent research involving the use of objective PA monitors shows that stroke
survivors are significantly less active than controls and maintain a high level of SB
one-year after discharge, regardless of functional capacity. This is especially problematic
given that patients who engage in low PA and high SB levels after stroke experience
cardiovascular deconditioning, worsening PA intolerance, and additional disability,
ultimately increasing risk for recurrent events.

Several barriers may account for low PA and high SB levels in stroke survivors. Many avoid
engaging in PA due to fear of falling or triggering a recurrent event. However, the risk of
inactivity in this regard is far greater than any risks associated with adopting habitual PA.
Other barriers may include post-stroke fatigue, depression, lack of interest, or motivation,
negative beliefs towards PA, and lack of support for PA behavior change. Despite the obvious
need for behavioral interventions to assist stroke survivors in overcoming barriers to
adoption and maintenance of habitual PA, there have been relatively few. Most interventions
to date have only included intensive and costly supervised exercise components and have not
included instruction in standard PA behavior change strategies (e.g., self-monitoring,
goal-setting, reinforcement).

The recent advent of commercially available mobile health (mHealth) technologies that
automatically monitor and provide feedback on time spent in PA and SB (i.e., fitness/activity
trackers) provide a potentially powerful means to enhance the efficacy and reach of
interventions targeting stroke survivors. While a recent randomized controlled trial showed
that providing a similar fitness/activity tracker in combination with a single in-person goal
setting/counseling session and related printed behavior change materials was more effective
than a pedometer and printed materials for increasing both daily moderate-to-vigorous PA
(MVPA) and steps in older overweight women, the feasibility, acceptability, and efficacy to
this approach in post-stroke and TIA patients is unknown.

The proposed project involves a randomized controlled trial to test the feasibility,
acceptability, and preliminary efficacy of a mHealth-enhanced PA intervention to increase
daily bout-related (≥10-minute bouts) and total (≥1-minute bouts) moderate-intensity PA (MPA)
and decrease daily SB in 70 non-physically impaired patients with ischemic stroke or TIA.
After visiting the Weight Control Diabetes Research Center (WCDRC) and completing a baseline
assessment that includes wearing a multi-sensor armband for 7 days to monitor daily MPA and
SB, participants will be randomized to 12 weeks of either: mHealth-enhanced PA intervention
(Tech-PAI; n=35) or a standard PA intervention (PAI; n=35), which will serve as an active
control group. Participants assigned to Tech-PAI will receive 2 face-to-face
goal-setting/counseling sessions (one at baseline to set individualized goals using data
observed on the baseline armband monitor) for the first 6 weeks of the intervention and the
other at the mid-intervention point (i.e. to evaluate progress and refine individualized
goals), a fitness/activity tracker and access to the accompanying website to monitor and
observe their progress towards set goals, weekly online skills training videos (during weeks
1-6) to help change PA and SB behaviors, and weekly e-mail feedback from research staff on
their progress towards goals (during weeks 1-12). Participants assigned to PAI will also
receive two face-to-face PA goal-setting counseling sessions, a pedometer, and printed
materials to assist with recording and increasing MPA and steps. Participants in both groups
will wear the multi-sensor armband monitor again for 7 days both at mid-intervention (end of
week 6) and post-intervention (end of week 12). The Tech-PAI and PAI groups will be compared
on changes in daily time spent in MPA and SB from baseline at mid- and post-intervention. At
these same time points, the groups will be compared on changes in performance-based measures
of cardiorespiratory/physical and cognitive function; questionnaire-based assessments of
stroke-specific impact and quality of life and PA-related attitudes and beliefs; and blood
pressure and inflammation (i.e. C-reactive protein levels collected via blood samples).
Finally, the acceptability of the Tech-PAI will be examined as indicated by fitness tracker
and related website usage patterns, completion of online skills training sessions, and
participant satisfaction ratings.

Inclusion Criteria:

- Admitted to hospital with a diagnosis of TIA or ischemic stroke

- Pre-Discharge Modified Rankin Scale (mRS) or 0 or 1 indicating "no symptoms at all" or
"no significant disability despite symptoms: able to carry out all usual duties and
activities"

- No major signs or symptoms suggestive of cardiovascular, pulmonary, or metabolic
disease (as determined by attending physician)

- Are able to successfully complete a submaximal graded exercise test at baseline

- Have access to a home or mobile computer (desktop, laptop, tablet, or smart phone)

Exclusion Criteria:

- Are participating in any other research study or structured exercise intervention that
might interfere with the proposed study

- Report any condition that in the opinion of investigators would reduce the likelihood
of adherence to the study protocol, such as terminal illness, planning to relocate, a
history of substance abuse or other significant psychiatric problems, etc.