Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK) (AquaSUP PARK)

• ClinicalTrials.gov Identifier: NCT03582371
• Recruitment Status: Completed
• First Posted: July 11, 2018
• Last Update Posted: April 10, 2023
• Sponsor: FLABEAU Olivier
• Information provided by (Responsible Party): FLABEAU Olivier, Centre Hospitalier de la côte Basque

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Rehabilitation	Procedure: Stand-Up Paddle Rehabilitation; Procedure: Physiotherapy Rehabilitation	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 91 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Outcomes Assessor)
• Masking Description: Patients will be scored Mini-Balance evaluation System Test by blinded investigators, before and after AquaSup or Physiotherapy
• Primary Purpose: Other
• Official Title: Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
• Actual Study Start Date: September 18, 2018
• Actual Primary Completion Date: September 8, 2022
• Actual Study Completion Date: September 8, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aqua SUP; 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.	Procedure: Stand-Up Paddle Rehabilitation; 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.
Active Comparator: Physiotherapy; Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.	Procedure: Physiotherapy Rehabilitation; Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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 ]
   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
2. Berg Balance Scale score variation [ Time Frame: Change from baseline Berg Balance Scale at 2 months ]
   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
3. Mini-Mental State Examination score variation [ Time Frame: Change from baseline Mini-Mental State Examination: at 2 months ]
   Mini-Mental State Examination test : Cognitice capacity evaluation, 6 items evaluated. Total score recorded : Minimum = 0 Maximum = 30 . Higher values represent a better outcome
4. Modified Timed Up and Go score variation [ Time Frame: Change from baseline Modified Modified Timed Up and Go at 2 months ]
   Modified Timed Up and Go Test : Functionnal capacity evaluation, Timing Walking test. Higher values represent a worse outcome
5. Global Mobility Task score variation [ Time Frame: Change from baseline Global Mobility Task at 2 months ]
   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
6. 2 minutes walking test score variation [ Time Frame: Change from baseline 2 minutes walking test 2 months ]
   2 minutes walking test : Timing Walking test. Higher values represent a better outcome
7. Posturographic data (Satel Platform) variation [ Time Frame: Change from baseline Posturographic data at 2 months ]
   Posturographic data test : Statokinesigram and stabilogram
8. Temporo-spatial parameters of gait (GAITRite walkway system) variation [ Time Frame: Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months ]
   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
9. Parkinson's Disease Questionnaire 39-item score variation [ Time Frame: Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months ]
   Parkinson's Disease Questionnaire 39-item test : Quality of life evaluation; 39 items quoted "never" "rarely" "sometimes" "often" or "always".
10. Beck Depression Inventory score variation [ Time Frame: Change from baseline Beck Depression Inventory at 2 months ]
    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
11. Clinical Global Impression (CGI) score variation [ Time Frame: Change from beseline Clinical Global Impression at 2 months ]
    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
12. Isokinetic lower-limb muscle strength results variation [ Time Frame: Change from baseline Isokinetic lower-limb muscle strength at 2 months ]
    Isokinetic lower-limb muscle strength test : muscular strenght evaluation. Right anf left quadriceps and harmstrings strenght evaluation. Higher values represent a better outcome
13. Maximal oxygen uptake (V02max) results variation [ Time Frame: Change from baseline Maximal oxygen uptake at 2 months ]
    Maximal oxygen uptake test : cardio-respiratory capacity evaluation. Higher value represent a better outcome

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).
• Persons subject to decision making support (eg. legal guardianship or conservator).
• Patients in the process of participating in another study.
• Pregnant woman.

Contacts and Locations

Locations

France

CH Côte Basque

Bayonne, France, 64109

Sponsors and Collaborators

FLABEAU Olivier

More Information

• Responsible Party: FLABEAU Olivier, Hospital practitionner, Centre Hospitalier de la côte Basque
• ClinicalTrials.gov Identifier: NCT03582371
• Other Study ID Numbers: P-2018/01
• First Posted: July 11, 2018
• Last Update Posted: April 10, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All IPD
• Supporting Materials: Clinical Study Report (CSR)
• Time Frame: End of study :June 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FLABEAU Olivier, Centre Hospitalier de la côte Basque:

Parkinson's Disease; Rehabilitation; Balance; Aquatic therapy; Stand Up Paddle

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases