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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04169620
• Other study ID #: spd205
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 7, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: November 2019
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 20, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Physical Disability

Intervention

Other:
• aquatic Ai Chi
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.
• control
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.

Locations

Country	Name	City	State
Spain	University of Almería	La CAñada de San Urbano	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed with VAS scale	VAS scale	ten weeks
Secondary	Balance assessed with Berg Balance scale	Berg Balance scale	ten weeks
Secondary	Functionality assessed with UPDRS scale	UPDRS scale	ten weeks