Clinical trial NCT04917133: Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay
Official title: Effect of Adapted Physical Activity, During Rehabilitation Stay, on Abilities and Quality of Life of Huntington Patients and Their Relatives "HUNT'ACTIV-MH-REHAB MOVE MORE TO LIVE BETTER"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Huntington Disease
Keywords: Adapted Physical Activity
Huntington's disease
rehabilitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Euromov Digital Health in Motion Montpellier France
First posted: 2021-06-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled randomized trial with two parallel arms
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria for the Patient :

* Mid-stage Huntington's disease but with the ability for an autonomous walking for 10 meter
* Age ≥ 18 years old
* 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
* 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
* Affiliated to a social security scheme

Inclusion Criteria for the Caregiver :

* Person participating in the daily life of the patient
* The patient is included in the research
* Age ≥ 18 years old
* Having received a complete information
* Non opposition collected by the investigator

Exclusion Criteria:

* Having a physical or psychiatric condition preventing the completion of the program and assessments.
* Having a history of additional major neurological disorders such as a stroke or an orthopedic condition limiting mobility
* 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
* Addictions, alcohol dependence
* Any other neurological, musculoskeletal or cardiovascular disease which could lead to errors in the assessment
* Participation to another interventional research or being in the exclusion period following a previous research if applicable
* Patient under AME (except if exemption from affiliation)

Exclusion criteria for the Caregiver :

* Having a physical or psychiatric condition preventing the completion of the program and assessments.
* 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
* Under tutelage or guardianship

Primary outcomes:
measure: Motor function score of Unified Huntington's Disease Rating Scale (UHDRS)
timeFrame: Change from Baseline at 1 month
Secondary outcomes:
measure: cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test
timeFrame: Change from Baseline at 1 month
measure: psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)
timeFrame: Change from Baseline at 1 month
Other outcomes:
Locations:
city: Hendaye
country: France
facility: Hôpital Marin de Hendaye
Study officials:
affiliation: Assistance Publique - Hôpitaux Paris
name: Pierre-André Natella, PhD
role: STUDY_DIRECTOR
References: