- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04619784
Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
The Effect of Pilates Application on Abdominal Muscle Function, Core Stability, Musculoskeletal Pain, Quality of Life, Anxiety and Depression in Parkinson's Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Evrim GOZ
- Phone Number: 02324124900
- Email: Evrim.goz@deu.edu.tr
Study Locations
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İzmir, Turkey, 35340
- Recruiting
- Dokuz Eylul University
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Contact:
- Evrim Goz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment Group
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.
|
Patients will receive 12 sessions of pilates.
|
OTHER: Control Group
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
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Their routine medical treatments were continued
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Function
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Core stability
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
"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
|
Musculoskeletal Pain
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
Quality of Life
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
Anxiety
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
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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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
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Pain intensity
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment
|
Depression
Time Frame: Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.
|
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.
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Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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