Follow-up of Patients' Physical Activity in Post-hospitalization (TICAA'DOM)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by University Hospital, Limoges.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University Hospital, Limoges
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
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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:
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 (Adult, Senior) |
| 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
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
| 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 September 23, 2016