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

Primary Purpose

Parkinson Disease, Physical Disability

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
aquatic Ai Chi
control
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Almería

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

variable aquatic Ai Chi

variable dry land

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain assessed with VAS scale
VAS scale

Secondary Outcome Measures

Balance assessed with Berg Balance scale
Berg Balance scale
Functionality assessed with UPDRS scale
UPDRS scale

Full Information

First Posted
November 2, 2016
Last Updated
November 15, 2019
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT04169620
Brief Title
Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial
Official Title
Effectiveness of a Program With Aquatic Therapy in Patients With Parkinson's Disease Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 7, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
December 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Physical Disability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
variable aquatic Ai Chi
Arm Type
Experimental
Arm Description
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.
Arm Title
variable dry land
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
aquatic Ai Chi
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain assessed with VAS scale
Description
VAS scale
Time Frame
ten weeks
Secondary Outcome Measure Information:
Title
Balance assessed with Berg Balance scale
Description
Berg Balance scale
Time Frame
ten weeks
Title
Functionality assessed with UPDRS scale
Description
UPDRS scale
Time Frame
ten weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Almería
City
La CAñada de San Urbano
State/Province
Almería
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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