HUNT'ACTIV: Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay
Study Details
Study Description
Brief Summary
Intro:
Huntington's disease is a neurodegenerative disease that affects the brain, inducing a dysfunction and death of the middle spiny striatal projection neurons and a progressive alteration of cognitive and motor functions, and psycho-behavioral problems. There is currently no curative treatment but we know hat a multidisciplinary care can optimize the functioning and the quality of life of the patients with Huntington's disease.
A meta-analysis of 18studies indicates that exercise and physical activity can improve motor function, gait speed and balance, and would also improve self-confidence, independence, well-being, reduced apathy and better socialization with family and friends.
Hypothesis/Objective The hypothesis is that the inclusion of a 4 week-program with Adapted Physical Activity (APA) during a rehabilitation stay will improve some motor, cognitive and psycho-behavioral abilities, compared to the control group.
Method
The patients will be randomized into two groups :
The control group will have the "classic" program performed in the standard of care with:
kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, and creation).
The experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective support : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests
For the two groups, at the start of the 4 weeks of rehabilitation program an initial visit will be performed with, as part of this research, a clinical examination, a neurological examination, a dietary consultation, as well as a biological assessment as part of habitual care.
The clinical examination, the neurological examination and the dietary consultation will be performed each week, during the 4 weeks of the program,
At the end of the study, one month after the rehabilitation of the patient, a visit by phone-call will be performed for the patient and his caregiver.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adapted Physical workshops The experimental APA group will have in addition of the classic program, 6 APA workshops per week with collective care : Adapted Physical workshops, adapted cycling, therapeutic (horseback/equestrian) riding, cultural or leisure outings, situation tests |
Behavioral: Adapted Physical Activity program
classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care
|
| Other: Control Standard of care The control group will have the "classic" program performed in the standard of care with : kinesitherapy, soft gym, medico-social workshop, cognitive workshop, creative workshop, individual care (rehabilitation, rest, creation). |
Other: Control
classic 4-week rehabilitation program (standard care)
|
Outcome Measures
Primary Outcome Measures
- Motor function score of Unified Huntington's Disease Rating Scale (UHDRS) [Change from Baseline at 1 month]
UHDRS:Unified Huntington's Disease Rating Scale , minimum value: 0 maximum value: 124 higher score means a worse outcome Success will be defined by an improvement of the motor function score
Secondary Outcome Measures
- cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test [Change from Baseline at 1 month]
UHDRS:Unified Huntington's Disease Rating Scale , minimal number of correct answers:0 maximal number of correct answers:100 higher score means a better outcome Success will be defined by an improvement of the cognitive function score
- psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS) [Change from Baseline at 1 month]
UHDRS:Unified Huntington's Disease Rating Scale , minimum value:0 maximal value:88 higher score means a worse outcome Success will be defined by an improvement of the behavioral function score
Eligibility Criteria
Criteria
Inclusion Criteria for the Patient :
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Mid-stage Huntington's disease but with the ability for an autonomous walking for 10 meter
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Age ≥ 18 years old
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Stable medication for at least 4 weeks before the start of the study and a stable diet during the duration of the program. A stable diet means no weight loss up to 2kg in the last month prior to inclusion
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Patient who received a complete information and who signed an informed consent for the research (or his/her caregiver if incapacity to sign). Tutor/Guardian who received a complete information and who signed an informed consent for the research if applicable
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Affiliated to a social security scheme
Inclusion Criteria for the Caregiver :
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Person participating in the daily life of the patient
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The patient is included in the research
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Age ≥ 18 years old
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Having received a complete information
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Non opposition collected by the investigator
Exclusion Criteria:
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Having a physical or psychiatric condition preventing the completion of the program and assessments.
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Having a history of additional major neurological disorders such as a stroke or an orthopedic condition limiting mobility
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Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator
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Addictions, alcohol dependence
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Any other neurological, musculoskeletal or cardiovascular disease which could lead to errors in the assessment
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Participation to another interventional research or being in the exclusion period following a previous research if applicable
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Patient under AME (except if exemption from affiliation)
Exclusion criteria for the Caregiver :
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Having a physical or psychiatric condition preventing the completion of the program and assessments.
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Any difficulty to understand or read French which could possibly invalidate the relevance of the application of questionnaires according to the opinion of the investigator
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Under tutelage or guardianship
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Marin de Hendaye | Hendaye | France | 64700 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
- Euromov Digital Health in Motion Montpellier France
Investigators
- Study Director: Pierre-André Natella, PhD, Assistance Publique - Hôpitaux Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP210469
- 2021-A00423-38