Follow-up of Patients' Physical Activity in Post-hospitalization (TICAA'DOM)

August 10, 2018 updated by: University Hospital, Limoges

Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.

Physical exercise has been identified as a major item of many affecting many chronic diseases and stroke rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side-effects and mortality. Stroke in association with an inactive lifestyle lead to a decrease in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to vicious circle of less and less mobility. Therefore, physical activity for the health is a valid and relevant way to improve the quality of life and to recover functional capacity. The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

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

  • France
      • Limoges, France, 87 042
        • University Hospital, Limoges

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Person having stroke (ischemic or hemorrhagic)
  • Whatever the area of stroke
  • Person supported by HEMIPASS (monitoring team and home support)
  • Stroke less than 6 months
  • Patient walking with or without technical or human assistance: FCC score

Exclusion Criteria:

  • Disability limiting the gait before the stroke
  • Age < 18 years
  • Cognitive impairment limiting participation to the program
  • Non signature of the consent
  • cardiopulmonary pathology which forbid/banned effort

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
No intervention
Experimental: effects of a incentive program for physical activity
The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke
Other: incentive program for physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The distance on the 6 minute walking test (6MWT)
Time Frame: 6 minutes
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: at 0 month, 6 months and 12 months
EQ-5D
at 0 month, 6 months and 12 months

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

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)

May 1, 2013

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 2, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • I12006 / TICAA'DOM

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.

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