The Stroke and Exercise Program

NCT02701998 | Unknown DMC

• 1 other identifier: 2118-15
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke; Exercise; Sedentary Lifestyle; Ischemic Attack, Transient

Keywords

Ischemic Stroke; Transient Ischemic Attack; Physical Activity; Sedentary Behavior; Lifestyle; Behavior

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Change in performance-based measure of cardiorespiratory functioning

  Baseline, Midpoint of 12-week intervention, End of 12-week intervention

• Change in performance-based measure of physical functioning

  Baseline, Midpoint of 12-week intervention, End of 12-week intervention

• Change in performance-based measure of cognitive function

  Baseline, Midpoint of 12-week intervention, End of 12-week intervention

• Change in stroke-related impact

  Baseline, Midpoint of 12-week intervention, End of 12-week intervention

• Change in health-related quality of life

  Baseline, Midpoint of 12-week intervention, End of 12-week intervention

Study Arms (2)

mHealth-Enhance Physical Activity Intervention

EXPERIMENTAL

Tech-PAI participants will be given 3 goals: 1) to increase their average baseline daily walking exercise by 30 minutes at week 12; 2) to increase their average baseline daily steps by 4,000 at week 12; and 3) to get up and walk for at least 2 minutes after every 60 minutes of sitting. Participants will receive instruction on how to gradually and safely increase their bout-related walking exercise and steps over the 12 week period. In addition to goal setting, Tech-PAI participants will receive a commercially available activity tracker and accompanying that provides real-time monitoring of steps, activity minutes, and issues a text-based prompt after 60 minutes of sitting to get up and move. Also, participants will receive a weekly e-mail feedback message from research staff on goal progress and will be asked to view weekly Internet-based video lessons that will provide behavioral strategies to increase MPA and steps and decrease SB during the first 6 weeks of the intervention period.

Behavioral: mHealth-Enhance Physical Activity Intervention

Physical Activity Intervention

ACTIVE COMPARATOR

PAI participants will be given the same goals as Tech-PAI intervention participants and receive a pedometer and related print materials to assist them in recording and increasing daily steps and bout-related MPA (but no activity tracker, access to video-based skills training lessons, or weekly feedback).

Other: Physical Activity Intervention

Interventions

mHealth-Enhance Physical Activity Intervention BEHAVIORAL

Also known as: Tech-PAI

mHealth-Enhance Physical Activity Intervention

Physical Activity Intervention OTHER

Also known as: PAI

Physical Activity Intervention

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity; Sedentary Behavior; Ischemic Attack, Transient; Ischemic Stroke; Behavior

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Central Study Contacts

Dale S Bond, Ph.D

CONTACT

401-793-8950; dbond@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 8, 2016
• Study Start: November 1, 2015
• Primary Completion: July 1, 2019
• Study Completion: November 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)