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Completed

NCT Number: NCT03582371

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Côte Basque

Bayonne, 64109, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stand-Up Paddle Rehabilitation

Procedure

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

Procedure

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

FLABEAU Olivier

Other

Registry information

Official study title

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

Acronym: AquaSUP PARK

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2018
Registry last updated
Apr 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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