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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507894
• Other study ID #: ConsorciST
• Status: Completed
• Start date: April 3, 2018
• Est. completion date: January 31, 2019

Study information

• Verified date: August 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 31, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Multimodal Exercise Rehabilitation Program
Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Adherence will be monitored with an app that will record activity time (walking time and distance)	8 weeks
Secondary	Gait speed	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