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

NCT04917133 | Completed

• 2 other identifiers: APHP2104692021-A00423-38
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Adapted Physical Activity; Huntington's disease; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Motor function score of Unified Huntington's Disease Rating Scale (UHDRS)

  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

  Change from Baseline at 1 month

Secondary Outcomes (2)

• cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test

  Change from Baseline at 1 month

• psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)

  Change from Baseline at 1 month

Study Arms (2)

Adapted Physical workshops

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Adapted Physical Activity program BEHAVIORAL

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

Adapted Physical workshops

Control OTHER

classic 4-week rehabilitation program (standard care)

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mid-stage Huntington's disease but with the ability for an autonomous walking for 10 meter
• Age ≥ 18 years old
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Euromov Digital Health in Motion Montpellier France: collaborator

Study Sites (1)

Hôpital Marin de Hendaye

Hendaye, 64700, France

Location

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pierre-André Natella, PhD

  Assistance Publique - Hôpitaux Paris

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: controlled randomized trial with two parallel arms

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: June 8, 2021
• Study Start: June 7, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)