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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01822938
First received: March 25, 2013
Last updated: March 19, 2014
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Other: incentive program for physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.

Resource links provided by NLM:

MedlinePlus related topics: Health Checkup
U.S. FDA Resources

Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • The distance on the 6 minute walking test (6MWT) [ Time Frame: 6 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: at 0 month, 6 months and 12 months ] [ Designated as safety issue: No ]
    EQ-5D
Estimated Enrollment: 84
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: control group
No intervention

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822938

Contacts
Contact: Jean-Christophe DAVIET, MD (+33)05 55 05 65 16

Locations
France
University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Jean-Christophe DAVIET, PhD    (+33) 5 55 05 65 16    jean-christophe.daviet@unilim.fr   
Principal Investigator: Jean-Christophe DAVIET, PhD         
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01822938     History of Changes
Other Study ID Numbers: I12006 / TICAA'DOM
Study First Received: March 25, 2013
Last Updated: March 19, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on March 03, 2015