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

Parkinson Disease Clinical Trial

— AquaSUP PARK  

Official title:

Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582371
• Other study ID #: P-2018/01
• Status: Completed
• Phase: N/A
• Start date: September 18, 2018
• Est. completion date: September 8, 2022

Study information

• Verified date: April 2023
• Source: Centre Hospitalier de la côte Basque
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Rehabilitation

Intervention

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.
• Physiotherapy Rehabilitation
Patients in the control group will receive a conventional physiotherapy session of 1 hour, twice a week, for 8 weeks.

Locations

Country	Name	City	State
France	CH Côte Basque	Bayonne

Sponsors (1)

Lead Sponsor	Collaborator
FLABEAU Olivier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Posturographic data (Satel Platform) variation	Posturographic data test : Statokinesigram and stabilogram	Change from baseline Posturographic data at 2 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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