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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04619784
Other study ID # DokuzEU2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 16, 2018
Est. completion date December 31, 2021

Study information

Verified date November 2020
Source Dokuz Eylul University
Contact Evrim GOZ
Phone 02324124900
Email Evrim.goz@deu.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients.


Description:

Objective: In this study, it is aimed to investigate the effect of Pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in Parkinson's Patients. Method: The study included 15 Idiopathic Parkinson's Patients over 18 years of age, under stage 3 according to the Hoehn-Yahr clinical staging. Patients were divided into intervention and control groups. Pilates training was performed for 6 weeks, twice a week and 60 minutes per session in intervention group. Demographic features will be questioned and recorded in the data recording form through mutual interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. All patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosed with Idiopathic Parkinson's Disease - Must be older 18 years old - Must have 24 and above score on Mini Mental Test - Must be the third or lower stage according to the Hoehn-Yahr staging - Must have stable clinical status Exclusion Criteria: - Musculoskeletal or cognitive impairment at a level affecting evaluation and treatment - Other neurological disease

Study Design


Intervention

Other:
Pilates Exercises
Patients will receive 12 sessions of pilates.
control
Their routine medical treatments were continued

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Function Muscle thickness measurement will be used to evaluate the function of transversus. Ultrasonography with a linear transducer (MHz) will use to measure the Transversus Abdominis thickness both at rest and during the abdominal drawing-in maneuver (ADIM). During ADIM, participants will be asked to abdominal hollowing which will be a gentle voluntary contraction of abdominal wall. All images are obtained at the end of expiration not to allow the effect of respiration on muscle thickness. Three measures are recorded in the both condition. The average values of measures are used in the data analysis. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Core stability "Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Musculoskeletal Pain Musculoskeletal pain will be evaluated with The Nordic Musculoskeletal Questionnaire. Questionnaire includes 27 items exploring the presence of musculoskeletal symptoms during a 12-month period covering in nine different parts of the body (i.e. neck, shoulders, elbows, wrists/hands, upper back, lower back, hips/tights, knees, ankles/feet) [21]. It also has items pertaining to severity grades, determined according to functional status and the presence of musculoskeletal symptoms during the last seven days. All answers are given according to a dichotomous 'yes/no' response.The Turkish version of the NMQ has appropriate psychometric properties, including good test-retest reliability, internal consistency and construct validity. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Quality of Life Quality of Life will be evaluated with 8-Item Parkinson's Disease Questionnaire / PDQ-8.The PDQ-8 is a brief form of the PDQ-39. One question from each of the eight domains on the PDQ-39 which are activities of daily living, bodily discomfort, cognition, communication, emotional well-being, mobility, social support, and stigma was chosen based on the strength of its correlation with the total domain score. Each question was scored from 0-4 points, and the scores were summed. The summed score was then divided by total possible score, and given as a percentage score out of 100. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Anxiety Anxiety will be evaluated with Beck Anxiety Inventory. It is a 21-item questionnaire that includes 4-point Likert-type options with a score of 0-3 and measures the level of anxiety. The higher the total score indicates the severity of anxiety. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Pain intensity Pain intensity will be evaluated with Visual Analog Scale. 10 cm long horizontal or vertical, numbered 1-10 forms are used.0 means no pain, 10 means unbearable pain. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Depression Depression will be evaluated with Beck Depression Inventory. It is a 21-item scale. The items contain sentences of four degrees that progress from less to more, which the participant will evaluate himself. The scale can be scored between 0 and 63. The high total score indicates the severity of the depression. Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.
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