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

FLABEAU Olivier91 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from baseline 2 minutes walking test 2 months

Posturographic data (Satel Platform) variation

Posturographic data test : Statokinesigram and stabilogram

Time frame: 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

Time frame: 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".

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Change from baseline Maximal oxygen uptake at 2 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes