Clinical trial NCT04169620: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Physical Disability
Lead sponsor: Universidad de Almeria
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain assessed with VAS scale
timeFrame: ten weeks
Secondary outcomes:
measure: Balance assessed with Berg Balance scale
timeFrame: ten weeks
measure: Functionality assessed with UPDRS scale
timeFrame: ten weeks
Other outcomes:
Locations:
city: La CAñada de San Urbano
country: Spain
facility: University of Almería
state: Almería
Study officials:
References: