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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Rehabilitation
• Intervention / Treatment: Procedure: Stand-Up Paddle Rehabilitation; Procedure: Physiotherapy Rehabilitation

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bayonne, France, 64109
    • CH Côte Basque

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline Mini-Balance Evaluation Systems Test at 2 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	Change from baseline 2 minutes walking test 2 months
Posturographic data (Satel Platform) variation	Posturographic data test : Statokinesigram and stabilogram	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	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".	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	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	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	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	Change from baseline Maximal oxygen uptake at 2 months

Collaborators and Investigators

• Sponsor: FLABEAU Olivier

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Balance; Parkinson's Disease; Aquatic therapy; Stand Up Paddle
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: P-2018/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD
• IPD Sharing Time Frame: End of study :June 2023
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No