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

NCT04169620 | Unknown

• 1 other identifier: spd205
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Physical Disability

Outcome Measures

Primary Outcomes (1)

• Pain assessed with VAS scale

  VAS scale

  ten weeks

Secondary Outcomes (2)

• Balance assessed with Berg Balance scale

  ten weeks

• Functionality assessed with UPDRS scale

  ten weeks

Study Arms (2)

variable aquatic Ai Chi

EXPERIMENTAL

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

variable dry land

PLACEBO COMPARATOR

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

Interventions

aquatic Ai Chi OTHER

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.

variable aquatic Ai Chi

control OTHER

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.

variable dry land

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

University of Almería

La Cañada de San Urbano, Almería, 04120, Spain

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 20, 2019
• Study Start: January 7, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 20, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

ES (1)