Recruiting

Exercise Program

Sponsor:

The Miriam Hospital

Code:

NCT02701998

Conditions

Stroke

Exercise

Sedentary Lifestyle

Ischemic Attack, Transient

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

mHealth-Enhance Physical Activity Intervention

Physical Activity Intervention

Study Details

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

Study ID

NCT02701998

Start date

Nov, 2015

Status verified date

Aug, 2018

Completion date

Nov, 2019

Anticipated

Primary completion date

Jul, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mHealth-Enhance Physical Activity Intervention

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.

active comparator: Physical Activity Intervention

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).

Interventions

mHealth-Enhance Physical Activity Intervention

Physical Activity Intervention

Primary outcome measure

  • Feasibility and acceptability of a mHealth-enhanced PA intervention via questionnaires [ Time Frame: End of 12-week intervention ]
  • Change in daily bout-related and total moderate physical activity [ Time Frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention ]
  • Change in daily percentage of waking hours spent in sedentary behavior [ Time Frame: Baseline, Midpoint of 12-week intervention, End of 12-week intervention ]

Central Contacts and Locations

Central contacts

Dale S Bond, Ph.D

401-793-8950dbond@lifespan.org

Locations

The Miriam Hospital Weight Control and Diabetes Research Center

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Dale S Bond, Ph.D

401-793-8950dbond@lifespan.org

Principal Investigator:

Dale S Bond, Ph.D

More Information

Sponsor

The Miriam Hospital

Last update posted

Mar 6, 2019

Last verified

Aug, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Miriam Hospital on 2019-03-06.