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Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients

Primary Purpose

Parkinson Disease, Pilates, Muscle Function

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Exercises
control
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

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

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

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment Group

Control Group

Arm Description

Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Patients will receive 12 sessions of pilates. Patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.

Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Their routine medical treatments were continued

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Core stability
"Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately.
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.
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.
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.
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.
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.

Full Information

First Posted
August 4, 2020
Last Updated
November 5, 2020
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT04619784
Brief Title
Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
Official Title
The Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

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
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Pilates, Muscle Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Patients will receive 12 sessions of pilates. Patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.
Arm Title
Control Group
Arm Type
Other
Arm Description
Demographic features will be questioned and recorded in the data recording form through face to face interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. Their routine medical treatments were continued
Intervention Type
Other
Intervention Name(s)
Pilates Exercises
Intervention Description
Patients will receive 12 sessions of pilates.
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
Their routine medical treatments were continued
Primary Outcome Measure Information:
Title
Muscle Function
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Secondary Outcome Measure Information:
Title
Core stability
Description
"Core" endurance and "core" power are the specific components of "core" stability and will be evaluated separately.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Title
Musculoskeletal Pain
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Title
Quality of Life
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Title
Anxiety
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Title
Pain intensity
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
Title
Depression
Description
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.
Time Frame
Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evrim GOZ
Phone
02324124900
Email
Evrim.goz@deu.edu.tr
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evrim Goz

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients

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