Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay (HUNT'ACTIV)

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"

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.

Study Overview

• Status: Completed
• Conditions: Huntington Disease
• Intervention / Treatment: Behavioral: Adapted Physical Activity program; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Hendaye, France, 64700
    • Hôpital Marin de Hendaye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test	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	Change from Baseline at 1 month
psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)	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	Change from Baseline at 1 month

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Euromov Digital Health in Motion Montpellier France
• Investigators: Study Director: Pierre-André Natella, PhD, Assistance Publique - Hopitaux Paris

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): December 7, 2021
• Study Completion (Actual): December 7, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 15, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: rehabilitation; Adapted Physical Activity; Huntington's disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Dyskinesias; Heredodegenerative Disorders, Nervous System; Dementia; Cognition Disorders; Chorea; Huntington Disease
• Other Study ID Numbers: APHP210469; 2021-A00423-38 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No