Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay

Not Applicable

Completed

• Conditions: Huntington Disease
• Interventions: Behavioral: Adapted Physical Activity program; Other: Control

• Registration Number: NCT04917133
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-10
• Study Start: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-08
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapted Physical workshops	Adapted Physical Activity program	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
Control	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital Marin de Hendaye; 🇫🇷 Hendaye, France