Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke.

August 30, 2023 updated by: Montserrat Grau-Pellicer, Consorci Sanitari de Terrassa

Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study

The aim of this study is to determine the impact of an m-health based intervention on long term adherence to a rehabilitation program for stroke survivors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a 8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology. The aim of the MERP is to improve walking speed, walking ability, activities of daily living and quality of life among people who have suffered a stroke. The mobile app technology complements the MERP in order to achieve long term adherence to healthy physical activity.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08232
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants will be stroke survivors who have completed a conventional rehabilitation program. They will be recruited from Hospital-Consorci Sanitari de Terrassa (Barcelona, Spain) over a period of six months.

Description

Inclusion Criteria:

  • Diagnosis of ischemic or hemorrhagic stroke
  • age ≥18;
  • Functional Ambulation Classification (FAC) ≥3
  • Barthel Index ≥45

Exclusion Criteria:

  • Cognitive impairment (Mini Mental State Examination ≤24)
  • Unstable cardiovascular disease (acute heart failure, recent myocardial infarction, unstable angina and uncontrolled arrhythmias)
  • Alcohol or other toxic substances abuse
  • Decompensated psychiatric disorders that prevented from following a group session

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
m-health stroke rehabilitation
8-week multimodal exercise rehabilitation program (MERP) based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology
Behavioral: Multimodal Exercise Rehabilitation Program
Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 8 weeks
Adherence will be monitored with an app that will record activity time (walking time and distance)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: 8 weeks
Gait speed will be measured with the Ten Meter Walking Test (10MWT). Participants will be given a 2-meter warm-up distance for walking, preceding the 10-meter distance, and 2 meters beyond the 10 meters. The time that takes to walk 10 meters at a comfortable pace and at their maximum speed will be registered in meters/second
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Investigators

  • Principal Investigator: Montserrat Grau-Pellicer, PhD, Consorci Sanitari de Terrassa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2018

Primary Completion (Actual)

December 28, 2018

Study Completion (Actual)

January 31, 2019

Study Registration Dates

First Submitted

April 16, 2018

First Submitted That Met QC Criteria

April 24, 2018

First Posted (Actual)

April 25, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ConsorciST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Multimodal Exercise Rehabilitation Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe