ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01822938
Recruitment Status : Unknown
Verified December 2012 by University Hospital, Limoges.
Recruitment status was:  Recruiting
First Posted : April 4, 2013
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Other: incentive program for physical activity Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.
Study Start Date : March 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The distance on the 6 minute walking test (6MWT) [ Time Frame: 6 minutes ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: at 0 month, 6 months and 12 months ]
    EQ-5D


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01822938     History of Changes
Other Study ID Numbers: I12006 / TICAA'DOM
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: December 2012