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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507894
Recruitment Status : Unknown
Verified January 2019 by Montserrat Grau-Pellicer, Consorci Sanitari de Terrassa.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Montserrat Grau-Pellicer, Consorci Sanitari de Terrassa

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Stroke Behavioral: Multimodal Exercise Rehabilitation Program

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 Design
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Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of M-health Based Intervention on Adherence to Healthy Physical Activity After Stroke. Randomized Study
Actual Study Start Date : April 3, 2018
Actual Primary Completion Date : December 28, 2018
Estimated Study Completion Date : January 26, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Adherence [ Time Frame: 8 weeks ]
    Adherence will be monitored with an app that will record activity time (walking time and distance)


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507894


Locations
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Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08232
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Investigators
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Principal Investigator: Montserrat Grau-Pellicer, PhD Consorci Sanitari de Terrassa
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Montserrat Grau-Pellicer, Principal Investigator, Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier: NCT03507894    
Other Study ID Numbers: ConsorciST
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montserrat Grau-Pellicer, Consorci Sanitari de Terrassa:
rehabilitation
exercise
stroke
adherence
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases