Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial

Study Overview
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Brief Summary
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The aim of this study is to determine the effect of an aquatic Ai Chi training program on the perception of pain, the maintenance of balance and the functional independence of patients with Parkinson's disease. Fifteen patients diagnosed with Parkinson's disease (Hoehn and Yahr range: 1-3) participated in a program of Aquatic Ai Chi lasting ten weeks with sessions held twice weekly. These were compared to a group of 15 Parkinson patients (control group) who received therapy on dry land.

Detailed Description
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All study participants met the following inclusion criteria: individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation). The exclusion criteria were: individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait. The procedure of randomization was performed for the overall sample using stratified randomization controlling for the Hoehn & Yahr stage employing Excell software (Microsoft Excell 2013: Microsoft Corp. Redmond WA). The participants received an initial assessment on dry land lasting 30-45 minutes, performed by a physiotherapist not involved in the study. Timetable norms were disclosed as well as recommendations regarding appropriate clothing for the activity. A baseline assessment was performed prior to commencing therapy. This was repeated upon completion of all sessions while a follow-up assessment took place one month later.

Official Title
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Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial

Conditions
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Parkinson Disease, Physical Disability

Intervention / Treatment
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* Other: aquatic Ai Chi
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals diagnosed with PD in stages 1 to 3 (Hoehn and Yahr Scale), older than 40 years, in the off phase (not medicated) and with a score greater or equal to 24 on the Mini-Mental State Examination Scale, without any medical contraindications and who accepted the study norms (regular assistance and active participation). Exclusion Criteria: individuals who did not comply with the above mentioned criteria, and the presence of articular and/or muscular lesions in the lower limbs affecting independent gait.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: variable aquatic Ai Chi<br>The 15 patients assigned to the aquatic therapy group (experimental group) received 20 twice-weekly sessions in total, during the same period of time as the control group. These 20 sessions consisted of group sessions lasting 45-minutes. The sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements. | Other: aquatic Ai Chi<br>* The sessions took place in a pool measuring 20 m x 6 m, at a depth of 110 cm. The water temperature was 30oC (with variations of less than 0.5o) and the room temperature was 27.5oC (with variations of less than 1o). The proportions of the pool were ideally suited for collective treatment. The sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements.<br>|
| Placebo Comparator: variable dry land<br>These sessions consisted of group sessions of supervised training lasting 45 minutes each. These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs. The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups. Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching. | Other: control<br>* These sessions consisted of group sessions of supervised training lasting 45 minutes each. These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs. The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups. Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessed with VAS scale | VAS scale | ten weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance assessed with Berg Balance scale | Berg Balance scale | ten weeks | 
| Functionality assessed with UPDRS scale | UPDRS scale | ten weeks |