The Stroke and Exercise Program

Stroke Clinical Trial

— StEP  

Official title:

Development and Pilot Testing of a Scalable mHealth Intervention to Promote Physical Activity in TIA and Stroke Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701998
• Other study ID #: 2118-15
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2019

Study information

• Verified date: August 2018
• Source: The Miriam Hospital
• Contact: Dale S Bond, Ph.D
• Phone: 401-793-8950
• Email: dbond[@]lifespan.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Ischemic Attack, Transient
• Sedentary Lifestyle
• Stroke

Intervention

Behavioral:
• mHealth-Enhance Physical Activity Intervention

Other:
• Physical Activity Intervention

Locations

Country	Name	City	State
United States	The Miriam Hospital Weight Control and Diabetes Research Center	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires	Feasibility and acceptability will be measured at the end of the 12-week intervention via questionnaires	End of 12-week intervention
Primary	Change in daily bout-related and total moderate physical activity	Physical activity will be objectively assessed via a multi-sensor monitor.	Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Primary	Change in daily percentage of waking hours spent in sedentary behavior	Sedentary behavior will be objectively assessed via a multi-sensor monitor.	Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in performance-based measure of cardiorespiratory functioning	Measured by submaximal graded exercise test	Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in performance-based measure of physical functioning	Measured by a physical functioning task	Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in performance-based measure of cognitive function		Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in stroke-related impact		Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in health-related quality of life		Baseline, Midpoint of 12-week intervention, End of 12-week intervention
Secondary	Change in C-reactive protein		Baseline, Midpoint of 12-week intervention, End of 12-week intervention