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Completed

NCT Number: NCT04917133

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Marin de Hendaye

Hendaye, 64700, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted Physical Activity program

Behavioral

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

Control

Other

classic 4-week rehabilitation program (standard care)

Primary outcomes

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

    Time frame: Change from Baseline at 1 month

    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

Secondary outcomes

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

    Time frame: Change from Baseline at 1 month

    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

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

    Time frame: Change from Baseline at 1 month

    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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Euromov Digital Health in Motion Montpellier France

Registry information

Official study 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"

Acronym: HUNT'ACTIV

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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