Parkinson DiseaseACTI-PARKNCT05685095
Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson
A study testing Physical training in people with Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD). Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2023to Oct 2026
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease, diagnosed for at least 2 years,
- Medical treatment (if any) unchanged in the past 4 weeks at least
- Hoehn \& Yahr score < 3
- Montreal cognitive assessment (MOCA) score between 20 and 30
- Able to understand the aim and methods of the study and provide signed informed consent-
Who cannot join
- Atypical parkinsonian syndrome
- Cardiovascular pathology preventing moderate physical exercise
- Orthostatic hypotension
- Any condition (other than PD) interfering with gait
- pregnant or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson
The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).
Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.
Read more
The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.
Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.
- Conditions
- Parkinson Disease
- Being tested
- Physical training
- Keywords
- adapted physical activity, gait, quality of life, actimetry, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical trainingBehavioural
Supervised gait training program 3 times a week, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treadmill walking | Experimental | The training program will last 12 weeks and consist of treadmill walking. The duration of the walking bouts (and pauses), and the speed of the belt will be adjusted as needed following the patients' progress. Music will be added as suited to boost motivation and support regular cadence. All training sessions will be supervised. Receives: Behavioral: Physical training |
| Nordic walking | Experimental | The training program will last 12 weeks and consist of Nordic walking, taught and supervised by an adapted physical activity teacher. The session will be carried out outside, weather permitting. When possible, training will gather 2 to 4 patients for group emulation. The duration of the walking bouts (and pauses) will be adjusted to follow the patients' progress. Receives: Behavioral: Physical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in daily energy expenditure
Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt.
Measured: recording 7 days in a row, at 3 months, 6 months and 9 months.
Secondary outcomes (5)
Evolution of gait parameters
Evolution over time of spatio-temporal gait parameters recorded during a gait test in the laboratory.
Measured: 3 months, 6 months and 9 months.
Evolution of exercise functional capacity
Evolution over time of the patients' performance at the 6 minutes walk test
Measured: 3 months, 6 months and 9 months.
Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.
Evolution of quality of life as measured using the PDQ.39 scale. Summed item scores expressed as percent. Min 0 Max 100.
Measured: 3 months, 6 months and 9 months.
Evolution over time of the Parkinsons' Disease Fatigue Scale score.
Evolution of fatigue as measured using the PD Fatigue scale. Min 0. Max 80. Greater score means greater fatigue
Measured: 3 months, 6 months and 9 months.
Adherence to the training program
number of training sessions attended
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study startFeb 2023 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionOct 2026 (estimated)
Why it stopped: personnel involved in clinical trial will not be available to conduct the research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Moro Elena, MD PhD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685095
- Sponsor's protocol ID
- 38RC22.0105_ACTI-PARK
- Other IDs
- 2022-A00678-35
- Acronym
- ACTI-PARK
- Status last verified
- Apr 2023
- First submitted
- 1 Sep 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson
- ClinicalTrials.gov ID
- NCT05685095
- Acronym / sponsor ID
- ACTI-PARK / 38RC22.0105_ACTI-PARK
- Conditions
- Parkinson Disease
- Keywords
- adapted physical activity, gait, quality of life, actimetry, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: personnel involved in clinical trial will not be available to conduct the research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Grenoble Alps, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Jan 2023 (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.
The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).
Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.
The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.
Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill walking | Experimental | Behavioral: Physical trainingThe training program will last 12 weeks and consist of treadmill walking. The duration of the walking bouts (and pauses), and the speed of the belt will be adjusted as needed following the patients' progress. Music will be added as suited to boost motivation and support regular cadence. All training sessions will be supervised. |
| Nordic walking | Experimental | Behavioral: Physical trainingThe training program will last 12 weeks and consist of Nordic walking, taught and supervised by an adapted physical activity teacher. The session will be carried out outside, weather permitting. When possible, training will gather 2 to 4 patients for group emulation. The duration of the walking bouts (and pauses) will be adjusted to follow the patients' progress. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease, diagnosed for at least 2 years,
- Medical treatment (if any) unchanged in the past 4 weeks at least
- Hoehn \& Yahr score < 3
- Montreal cognitive assessment (MOCA) score between 20 and 30
- Able to understand the aim and methods of the study and provide signed informed consent-
Key exclusion criteria (5 listed)
- Atypical parkinsonian syndrome
- Cardiovascular pathology preventing moderate physical exercise
- Orthostatic hypotension
- Any condition (other than PD) interfering with gait
- pregnant or nursing
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 |
|---|---|---|
| Physical trainingSupervised gait training program 3 times a week, 12 weeks | Behavioural | Nordic walking, Treadmill walking |
Primary outcome
Changes in daily energy expenditure
Time frame: recording 7 days in a row, at 3 months, 6 months and 9 months.
Evolution over time of the daily energy expenditure together with number of steps, as recorded using an actimeter worn at the belt.
5 secondary outcomes
Evolution of gait parameters
Time frame: 3 months, 6 months and 9 months.
Evolution of exercise functional capacity
Time frame: 3 months, 6 months and 9 months.
Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.
Time frame: 3 months, 6 months and 9 months.
Evolution over time of the Parkinsons' Disease Fatigue Scale score.
Time frame: 3 months, 6 months and 9 months.
Adherence to the training program
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Moro Elena, MD PhD principal investigator
Grenoble Alpes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical training in people with Parkinson Disease, run by University Hospital, Grenoble 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Apr 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Changes in daily energy expenditure (time frame: recording 7 days in a row, at 3 months, 6 months and 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2023.