Clinical trial NCT03582371: Aqua Stand-Up Paddle Balance Effect in Parkinson's Disease (AquaSUP PARK)
Official title: Effect of an Aqua Stand-Up Paddle Program on Postural Instability in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Rehabilitation
Keywords: Parkinson's Disease
Rehabilitation
Balance
Aquatic therapy
Stand Up Paddle
Lead sponsor: Centre Hospitalier de la côte Basque
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Mini-Balance Evaluation System Score variation
timeFrame: Change from baseline Mini-Balance Evaluation Systems Test at 2 months.
Secondary outcomes:
measure: Movement Disorder Society - Unified Parkinson's Disease rating Scale III score variation
timeFrame: Change from baseline Movement Disorder Society - Unified Parkinson's Disease rating Scale III at 2 months
measure: Berg Balance Scale score variation
timeFrame: Change from baseline Berg Balance Scale at 2 months
measure: Mini-Mental State Examination score variation
timeFrame: Change from baseline Mini-Mental State Examination: at 2 months
measure: Modified Timed Up and Go score variation
timeFrame: Change from baseline Modified Modified Timed Up and Go at 2 months
measure: Global Mobility Task score variation
timeFrame: Change from baseline Global Mobility Task at 2 months
measure: 2 minutes walking test score variation
timeFrame: Change from baseline 2 minutes walking test 2 months
measure: Posturographic data (Satel Platform) variation
timeFrame: Change from baseline Posturographic data at 2 months
measure: Temporo-spatial parameters of gait (GAITRite walkway system) variation
timeFrame: Change from baseline Temporo-spatial parameters of GAITRite walkway system at 2 months
measure: Parkinson's Disease Questionnaire 39-item score variation
timeFrame: Change from baseline Parkinson's Disease Questionnaire 39-item at 2 months
measure: Beck Depression Inventory score variation
timeFrame: Change from baseline Beck Depression Inventory at 2 months
measure: Clinical Global Impression (CGI) score variation
timeFrame: Change from beseline Clinical Global Impression at 2 months
measure: Isokinetic lower-limb muscle strength results variation
timeFrame: Change from baseline Isokinetic lower-limb muscle strength at 2 months
measure: Maximal oxygen uptake (V02max) results variation
timeFrame: Change from baseline Maximal oxygen uptake at 2 months
Other outcomes:
Locations:
city: Bayonne
country: France
facility: CH Côte Basque
Study officials:
References: