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

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Brief Title

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

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"

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.
    



Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Huntington Disease

Intervention

Adapted Physical Activity program

Study Arms / Comparison Groups

 Adapted Physical workshops
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

32

Start Date

June 7, 2021

Completion Date

February 7, 2023

Primary Completion Date

February 7, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Pierre-André Natella, PhD, (0)5 59 48 08 20, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04917133

Organization ID

APHP210469

Secondary IDs

2021-A00423-38

Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

 Euromov Digital Health in Motion Montpellier France

Study Sponsor

Pierre-André Natella, PhD, Study Director, Assistance Publique - Hôpitaux Paris


Verification Date

May 2021