Huntington DiseaseHUNT'ACTIVNCT04917133
Adapted Physical Activity Effect on Abilities and Quality of Life of Huntington Patients and Relatives During Rehab Stay
A study testing Adapted Physical Activity program in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Adapted Physical Activity program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 7 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Person participating in the daily life of the patient
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- The patient is included in the research
- Age ≥ 18 years old
- Having received a complete information
- Non opposition collected by the investigator
Who cannot join
- 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
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- Patient under AME (except if exemption from affiliation)
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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"
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.
Read more
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.
- Conditions
- Huntington Disease
- Being tested
- Adapted Physical Activity program, Control
- Keywords
- Adapted Physical Activity, Huntington's disease, rehabilitation
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity programBehavioural
classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care
ControlOther
classic 4-week rehabilitation program (standard care)
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical workshops | Experimental | 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 Receives: Behavioral: Adapted Physical Activity program |
| Control | Other | 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). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline at 1 month
Secondary outcomes (2)
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
Measured: 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
Measured: Change from Baseline at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start7 Jun 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled randomized trial with two parallel arms
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Euromov Digital Health in Motion Montpellier France
- Responsible party
- Sponsor
- Investigators
- Pierre-André Natella, PhD, Study director, Assistance Publique - Hôpitaux Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917133
- Sponsor's protocol ID
- APHP210469
- Other IDs
- 2021-A00423-38
- Acronym
- HUNT'ACTIV
- Status last verified
- Sep 2022
- First submitted
- 10 May 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: APHP IS DATA'S OWNER, PLEASE CONTACT BOARD
Publications
Brusseau M, Soudrie B, Bachoud-Levi AC, Bannier S, Bourdain F, Jenkins M, Natella PA, Bombenger N, Boiche J. A moderate-intensity exercise program during inpatient rehabilitation for middle stage Huntington's disease: A randomized controlled trial. J Huntingtons Dis. 2026 Aug;15(3):453-467. doi: 10.1177/18796397261422975. Epub 2026 Mar 3.
PubMed 41773646
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04917133
- Acronym / sponsor ID
- HUNT'ACTIV / APHP210469
- Conditions
- Huntington Disease
- Keywords
- Adapted Physical Activity, Huntington's disease, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Euromov Digital Health in Motion Montpellier France
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- controlled randomized trial with two parallel arms
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical workshops | Experimental | Behavioral: Adapted Physical Activity programThe 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 |
| Control | Other | Other: ControlStandard 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted Physical Activity programclassic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care | Behavioural | Adapted Physical workshops |
| Controlclassic 4-week rehabilitation program (standard care) | Other | Control |
Primary outcome
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
2 secondary outcomes
cognitive function score of Unified Huntington's Disease Rating Scale (UHDRS) using Stroop test
Time frame: Change from Baseline at 1 month
psycho-behavioral function score of Unified Huntington's Disease Rating Scale (UHDRS)
Time frame: Change from Baseline at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Derived from this study: PubMed 41773646Brusseau M, Soudrie B, Bachoud-Levi AC, Bannier S, Bourdain F, Jenkins M, Natella PA, Bombenger N, Boiche J. A moderate-intensity exercise program during inpatient rehabilitation for middle stage Huntington's disease: A randomized controlled trial. J Huntingtons Dis. 2026 Aug;15(3):453-467. doi: 10.1177/18796397261422975. Epub 2026 Mar 3.
- Individual participant dataSharing planned: No. APHP IS DATA'S OWNER, PLEASE CONTACT BOARD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-André Natella, PhD study director
Assistance Publique - Hôpitaux Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity program in people with Huntington Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor function score of Unified Huntington's Disease Rating Scale (UHDRS) (time frame: Change from Baseline at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04917133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.