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

NCT ID: NCT04917133

Last Updated: 2022-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2021-12-07

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.

Conditions

Huntington Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Adapted Physical Activity program

Intervention Type: BEHAVIORAL

classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care

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).

Group Type: OTHER

Control

Intervention Type: OTHER

classic 4-week rehabilitation program (standard care)

Interventions

Adapted Physical Activity program

classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care

Intervention Type: BEHAVIORAL

Control

classic 4-week rehabilitation program (standard care)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euromov Digital Health in Motion Montpellier France

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-André Natella, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux Paris

Locations

Hôpital Marin de Hendaye

Hendaye, , France

Countries

France

Other Identifiers

2021-A00423-38

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210469

Identifier Type: -

Identifier Source: org_study_id