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

Primary Purpose

Huntington Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Adapted Physical Activity program

Control

About this trial

This is an interventional supportive care trial for Huntington Disease focused on measuring Adapted Physical Activity, Huntington's disease, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Marin de Hendaye

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Adapted Physical workshops

Control

Arm 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

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT04917133

First Posted

May 10, 2021

Last Updated

September 15, 2022

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Euromov Digital Health in Motion Montpellier France

1. Study Identification

Unique Protocol Identification Number

NCT04917133

Brief Title

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

Acronym

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"

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

June 7, 2021 (Actual)

Primary Completion Date

December 7, 2021 (Actual)

Study Completion Date

December 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Euromov Digital Health in Motion Montpellier France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Huntington Disease

Keywords

Adapted Physical Activity, Huntington's disease, rehabilitation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

controlled randomized trial with two parallel arms

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adapted Physical workshops

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Adapted Physical Activity program

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

classic 4-week rehabilitation program (standard care)

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Change from Baseline at 1 month

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Change from Baseline at 1 month

Title

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

Description

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

Time Frame

Change from Baseline at 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre-André Natella, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux Paris

Official's Role

Study Director

Facility Information:

Facility Name

Hôpital Marin de Hendaye

City

Hendaye

ZIP/Postal Code

64700

Country

France

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

APHP IS DATA'S OWNER, PLEASE CONTACT BOARD

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

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