Clinical trial NCT02701998: The Stroke and Exercise Program
Official title: Development and Pilot Testing of a Scalable mHealth Intervention to Promote Physical Activity in TIA and Stroke Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Exercise
Sedentary Lifestyle
Ischemic Attack, Transient
Keywords: Ischemic Stroke
Transient Ischemic Attack
Physical Activity
Sedentary Behavior
Lifestyle
Behavior
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves a randomized controlled trial to test the feasibility, acceptability, and efficacy of a mobile health (mHealth)-enhanced physical activity (PA) intervention to increase daily bout-related and total moderate-intensity PA and to reduce sedentary behavior (SB) in non-physically impaired patients with ischemic stroke or transient ischemic attack (TIA).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires
timeFrame: End of 12-week intervention
measure: Change in daily bout-related and total moderate physical activity
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in daily percentage of waking hours spent in sedentary behavior
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary outcomes:
measure: Change in performance-based measure of cardiorespiratory functioning
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in performance-based measure of physical functioning
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in performance-based measure of cognitive function
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in stroke-related impact
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in health-related quality of life
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
measure: Change in C-reactive protein
timeFrame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References: