Parkinson DiseaseAquaSUP PARKNCT03582371
Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)
A study testing Stand-Up Paddle Rehabilitation and Physiotherapy Rehabilitation in people with Parkinson Disease and Rehabilitation, run by FLABEAU Olivier at 1 site in France.
Trial summary
Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Rehabilitation
- What is being tested?
- Stand-Up Paddle Rehabilitation and Physiotherapy Rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2018to 8 Sep 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female aged 18 to 80 years of age.
- Patients suffering from idiopathic Parkinson's Disease according to the criteria of the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic.
- Presence of balance disorder : Stage Hoehn and Yahr 2.5 to 4.
- Motor level stable, without change of treatment in last 6 weeks
- Subjects affiliated to a social security scheme or beneficiary of an equivalent scheme
- Subjects are volunteers with their signed consent
Who cannot join
- Patients suffering from disabling neurological conditions other than IPD. Patients with progressive psychiatric pathologies.
- Patients with significant cognitive impairment (MMS <24).
- Presence of orthopedic problems incompatible with the practice of Aqua SUP.
- Medical advice against the practice of endurance exercise and muscle building.
- Patients with history or presence of cardiovascular or respiratory conditions, or patients who answered "yes" to any of the items in the Revised Physical Activity Readiness Questionnaire (Q-AAP).
- Patients with a condition which is deemed incompatible with the therapeutic pool: uncontrolled vesico-sphincteric disorder, aquaphobia, deterioration of the skin condition (wound, eschar, ulcer).
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- Persons subject to decision making support (eg. legal guardianship or conservator).
- Patients in the process of participating in another study.
- Pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Considering the proven effects of the Stand-up Paddle (SUP) activity on postural instability in sedentary people, the investigators wanted to develop this aquatic activity in a swimming pool on static conditions (Aqua SUP) for PD patients. The objective is to assess the postural instability change by measuring the Mini-Balance Evaluation Systems Test (miniBESTest) after 8 weeks of Aqua SUP compared to physiotherapy in PD patients with baseline postural instability.
Read the detailed description
Parkinson's disease (PD) is a relentless neurodegenerative disorder leading to functional impairment with postural instability. Postural instability is associated with an increased risk of falling and a decreased quality of life, and levodopa therapy may only have little effect on balance. Evidence supports physiotherapy and physical activity as an alternative treatment for postural instability in PD. Several types of physical activity have been tested in PD which target different specificities of rehabilitation such as stretching, muscle strengthening, balance, occupational therapy, cueing, treadmill training, with contrasting data regarding postural instability. The investigators want to develop an innovative physical activity with specific focus on the management of the postural instability in PD patients. Stand-up Paddle (SUP) is an aquatic sport improving postural instability in sedentary people that may be practiced in a swimming pool with static conditions for safety (Aqua SUP).
In order to assess the effect on postural instability, PD patients with baseline postural instability will be scored by Mini-Balance Evaluation Systems Test (miniBESTest) before and after 8 weeks of Aqua SUP practice and compared to physiotherapy according to a randomized controlled trial with non-inferiority design.
Patients will be clinically assessed at baseline regarding the primary outcome miniBESTest and secondary outcome measures. A secondary visit will take place at 2 months after inclusion (Aqua SUP versus physiotherapy). A tertiary visit will be completed at 6 months after inclusion to assess long term effects.
- Conditions
- Parkinson Disease, Rehabilitation
- Being tested
- Stand-Up Paddle Rehabilitation, Physiotherapy Rehabilitation
- Keywords
- Parkinson's Disease, Rehabilitation, Balance, Aquatic therapy, Stand Up Paddle
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stand-Up Paddle RehabilitationProcedure or surgery
Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool.
Physiotherapy RehabilitationProcedure or surgery
Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Aqua SUP | Experimental | Patients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool. Receives: Procedure: Stand-Up Paddle Rehabilitation |
| Physiotherapy | Active comparator | Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks. Receives: Procedure: Physiotherapy Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Balance Evaluation System Score variation
Mini-Balance Evaluation System Test : Postural instability with falling risk evaluation, 14 items quoted 0 (severe) to 2 (normal). Total score recorded : minimum =0 Maximum =28. Higher values represent a better outcome
Measured: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.
Secondary outcomes (13)
Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation
Movement Disorder Society - Unified Parkinson's Disease rating Scale III : Motor symptoms evaluation, 18 items quoted 0 (normal) to 4 (severe). Total score recorded : minimum =0 Maximum =72. Higher values represent a worse outcome
Measured: Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months
Berg Balance Scale score variation
Berg Balance Scale test : Balance and posture evaluation, 14 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 42. Higher values represent a worse outcome
Measured: Change from baseline Berg Balance Scale at 2 months
Mini-Mental State Examination score variation
Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome
Measured: Change from baseline Mini-Mental State Examination: at 2 months
Modified Timed Up and Go score variation
Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome
Measured: Change from baseline Modified Modified Timed Up and Go at 2 months
Global Mobility Task score variation
Global Mobility Task Test : Functionnal capacity evaluation; 5 items quoted 0(normal) to 4 (severe). Total score recorded : Minimum=0 Maximum = 20. Higher values represent a worse outcome
Measured: Change from baseline Global Mobility Task at 2 months
2 minutes walking test score variation
2 minutes walking test : Timing Walking test. Higher values represent a better outcome
Measured: Change from baseline 2 minutes walking test 2 months
Posturographic data (Satel Platform) variation
Posturographic data test : Statokinesigram and stabilogram
Measured: Change from baseline Posturographic data at 2 months
Temporo-spatial parameters of gait (GAITRite walkway system) variation
Temporo-spatial parameters of GAITRite walkway system test : Walking test : lengh, timing and speed recorded. Higher values represent a better outcome for speed and lengh
Measured: Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months
Parkinson's Disease Questionnaire 39-item score variation
Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted "never" "rarely" "sometimes" "often" or "always".
Measured: Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months
Beck Depression Inventory score variation
Beck Depression Inventory test : depression evaluation . 21 items quoted 0(normal) to 3 (severe). Total score recorded : Minimum=0 Maximum = 63. Higher values represent a worse outcome
Measured: Change from baseline Beck Depression Inventory at 2 months
Clinical Global Impression (CGI) score variation
Clinical Global Impression test : Global improvement evaluation : 1 item quoted 1 (very high improvement) to 7 (very high worsening). Higher value represent a worse outcome
Measured: Change from beseline Clinical Global Impression at 2 months
Isokinetic lower-limb muscle strength results variation
Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome
Measured: Change from baseline Isokinetic lower-limb muscle strength at 2 months
Maximal oxygen uptake (V02max) results variation
Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome
Measured: Change from baseline Maximal oxygen uptake at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start18 Sep 2018
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLABEAU Olivier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, FLABEAU Olivier, Centre Hospitalier de la côte Basque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582371
- Sponsor's protocol ID
- P-2018/01
- Acronym
- AquaSUP PARK
- Status last verified
- Apr 2023
- First submitted
- 26 Jun 2018
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03582371
- Acronym / sponsor ID
- AquaSUP PARK / P-2018/01
- Conditions
- Parkinson Disease, Rehabilitation
- Keywords
- Parkinson's Disease, Rehabilitation, Balance, Aquatic therapy, Stand Up Paddle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- FLABEAU OlivierUniversity, hospital or other
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 11 Jul 2018 (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.
Postural instability is associated with falls and a decreased quality of life in Parkinson's disease (PD). Evidence supports physical activity rather than levodopa for postural instability management. Considering the proven effects of the Stand-up Paddle (SUP) activity on postural instability in sedentary people, the investigators wanted to develop this aquatic activity in a swimming pool on static conditions (Aqua SUP) for PD patients. The objective is to assess the postural instability change by measuring the Mini-Balance Evaluation Systems Test (miniBESTest) after 8 weeks of Aqua SUP compared to physiotherapy in PD patients with baseline postural instability.
Detailed description
Parkinson's disease (PD) is a relentless neurodegenerative disorder leading to functional impairment with postural instability. Postural instability is associated with an increased risk of falling and a decreased quality of life, and levodopa therapy may only have little effect on balance. Evidence supports physiotherapy and physical activity as an alternative treatment for postural instability in PD. Several types of physical activity have been tested in PD which target different specificities of rehabilitation such as stretching, muscle strengthening, balance, occupational therapy, cueing, treadmill training, with contrasting data regarding postural instability. The investigators want to develop an innovative physical activity with specific focus on the management of the postural instability in PD patients. Stand-up Paddle (SUP) is an aquatic sport improving postural instability in sedentary people that may be practiced in a swimming pool with static conditions for safety (Aqua SUP).
In order to assess the effect on postural instability, PD patients with baseline postural instability will be scored by Mini-Balance Evaluation Systems Test (miniBESTest) before and after 8 weeks of Aqua SUP practice and compared to physiotherapy according to a randomized controlled trial with non-inferiority design.
Patients will be clinically assessed at baseline regarding the primary outcome miniBESTest and secondary outcome measures. A secondary visit will take place at 2 months after inclusion (Aqua SUP versus physiotherapy). A tertiary visit will be completed at 6 months after inclusion to assess long term effects.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Proof of concept. Study of non-inferiority, prospective, monocentric, randomized, controlled (Aqua SUP vs physiotherapy), in blind treatment compared to applied treatment.
| Arm | Type | Receives |
|---|---|---|
| Aqua SUP | Experimental | Procedure: Stand-Up Paddle RehabilitationPatients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool. |
| Physiotherapy | Active comparator | Procedure: Physiotherapy RehabilitationPatients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or Female aged 18 to 80 years of age.
- Patients suffering from idiopathic Parkinson's Disease according to the criteria of the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic.
- Presence of balance disorder : Stage Hoehn and Yahr 2.5 to 4.
- Motor level stable, without change of treatment in last 6 weeks
- Subjects affiliated to a social security scheme or beneficiary of an equivalent scheme
Key exclusion criteria (9 listed)
- Patients suffering from disabling neurological conditions other than IPD. Patients with progressive psychiatric pathologies.
- Patients with significant cognitive impairment (MMS <24).
- Presence of orthopedic problems incompatible with the practice of Aqua SUP.
- Medical advice against the practice of endurance exercise and muscle building.
- Patients with history or presence of cardiovascular or respiratory conditions, or patients who answered "yes" to any of the items in the Revised Physical Activity Readiness Questionnaire (Q-AAP).
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 |
|---|---|---|
| Stand-Up Paddle RehabilitationPatients in the Aqua SUP group will benefit from a 1 hour Aqua SUP session, twice a week, for 8 weeks in a therapeutic pool. | Procedure or surgery | Aqua SUP |
| Physiotherapy RehabilitationPatients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks. | Procedure or surgery | Physiotherapy |
Primary outcome
Mini-Balance Evaluation System Score variation
Time frame: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.
Mini-Balance Evaluation System Test : Postural instability with falling risk evaluation, 14 items quoted 0 (severe) to 2 (normal). Total score recorded : minimum =0 Maximum =28. Higher values represent a better outcome
13 secondary outcomes
Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation
Time frame: Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months
Berg Balance Scale score variation
Time frame: Change from baseline Berg Balance Scale at 2 months
Mini-Mental State Examination score variation
Time frame: Change from baseline Mini-Mental State Examination: at 2 months
Modified Timed Up and Go score variation
Time frame: Change from baseline Modified Modified Timed Up and Go at 2 months
Global Mobility Task score variation
Time frame: Change from baseline Global Mobility Task at 2 months
2 minutes walking test score variation
Time frame: Change from baseline 2 minutes walking test 2 months
Posturographic data (Satel Platform) variation
Time frame: Change from baseline Posturographic data at 2 months
Temporo-spatial parameters of gait (GAITRite walkway system) variation
Time frame: Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months
Parkinson's Disease Questionnaire 39-item score variation
Time frame: Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months
Beck Depression Inventory score variation
Time frame: Change from baseline Beck Depression Inventory at 2 months
Clinical Global Impression (CGI) score variation
Time frame: Change from beseline Clinical Global Impression at 2 months
Isokinetic lower-limb muscle strength results variation
Time frame: Change from baseline Isokinetic lower-limb muscle strength at 2 months
Maximal oxygen uptake (V02max) results variation
Time frame: Change from baseline Maximal oxygen uptake at 2 months
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 10 Apr 2023.
- Derived from this study: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
- Individual participant dataSharing planned: Yes. All IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stand-Up Paddle Rehabilitation and Physiotherapy Rehabilitation in people with Parkinson Disease and Rehabilitation, run by FLABEAU Olivier 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 6 inclusion and 9 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 10 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 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?
Mini-Balance Evaluation System Score variation (time frame: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.). 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 NCT03582371, which also lists 2 linked publications.
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 10 Apr 2023.