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

Huntington Disease Clinical Trial

— HUNT'ACTIV  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04917133
• Other study ID #: APHP210469
• Secondary ID: 2021-A00423-38
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Behavioral:
• Adapted Physical Activity program
classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care

Other:
• Control
classic 4-week rehabilitation program (standard care)

Locations

Country	Name	City	State
France	Hôpital Marin de Hendaye	Hendaye

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Euromov Digital Health in Motion Montpellier France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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