StrokeTICAA'DOMNCT01822938
Follow-up of Patients' Physical Activity in Post-hospitalization
A study testing incentive program for physical activity in people with Stroke, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- incentive program for physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- incentive program for physical activity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentive program for physical activityOther
| Study group | Role | What they receive |
|---|---|---|
| effects of a incentive program for physical activity | Experimental | The aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke Receives: Other: incentive program for physical activity |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The distance on the 6 minute walking test (6MWT)
Measured: 6 minutes
Secondary outcomes (1)
Quality of life
EQ-5D
Measured: at 0 month, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822938
- Sponsor's protocol ID
- I12006 / TICAA'DOM
- Acronym
- TICAA'DOM
- Status last verified
- Mar 2015
- First submitted
- 25 Mar 2013
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Guediri A, Chaparro D, Borel B, Daviet JC, Compagnat M, Mandigout S. The effect of a home-based coaching program on heart rate variability in subacute stroke patients: a randomized controlled trial. Int J Rehabil Res. 2022 Sep 1;45(3):201-208. doi: 10.1097/MRR.0000000000000529. Epub 2022 May 2.
PubMed 35502452Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.
PubMed 33197648Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.
PubMed 29370824
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Patients' Physical Activity in Post-hospitalization by Implementation of Systems of Active Monitoring.
- ClinicalTrials.gov ID
- NCT01822938
- Acronym / sponsor ID
- TICAA'DOM / I12006 / TICAA'DOM
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| effects of a incentive program for physical activity | Experimental | Other: incentive program for physical activityThe aim of the study is the assessment of the effects of a incentive program for physical activity on people following/with stroke |
| control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| incentive program for physical activity | Other | effects of a incentive program for physical activity |
Primary outcome
The distance on the 6 minute walking test (6MWT)
Time frame: 6 minutes
1 secondary outcome
Quality of life
Time frame: at 0 month, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 35502452Guediri A, Chaparro D, Borel B, Daviet JC, Compagnat M, Mandigout S. The effect of a home-based coaching program on heart rate variability in subacute stroke patients: a randomized controlled trial. Int J Rehabil Res. 2022 Sep 1;45(3):201-208. doi: 10.1097/MRR.0000000000000529. Epub 2022 May 2.
- Derived from this study: PubMed 33197648Mandigout S, Chaparro D, Borel B, Kammoun B, Salle JY, Compagnat M, Daviet JC. Effect of individualized coaching at home on walking capacity in subacute stroke patients: A randomized controlled trial (Ticaa'dom). Ann Phys Rehabil Med. 2021 Jul;64(4):101453. doi: 10.1016/j.rehab.2020.11.001. Epub 2020 Nov 28.
- Derived from this study: PubMed 29370824Chaparro D, Daviet JC, Borel B, Kammoun B, Salle JY, Tchalla A, Mandigout S. Home-based physical activity incentive and education program in subacute phase of stroke recovery (Ticaa'dom): study protocol for a randomized controlled trial. Trials. 2018 Jan 25;19(1):68. doi: 10.1186/s13063-017-2410-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incentive program for physical activity in people with Stroke, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The distance on the 6 minute walking test (6MWT) (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01822938, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.