- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04928833
Investigation of the Effects of Pilates Training in Parkinson Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ri̇ze
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Güneysu, Ri̇ze, Turkey, 53390
- Recep Tayyip Erdogan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- After providing information about the research, agreeing to participate in the research
- Being 40 years or older
- Being diagnosed with '' Idiopathic Parkinson's Disease '' by a specialist
- To be between 1-2.5 values according to Hoehn and Yahr (H&Y) Scale
Exclusion Criteria:
- Standardized Mini Mental Test score is less than 24
- Presence of cardiovascular, pulmonary, orthopedic or other medical conditions that limit participation in Pilates training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pilates Group
Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks.
|
Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks.
Before starting the exercise training, all subjects were taught the key elements of Pilates in 1 session.
Pilates training started with standing exercises for warming up and centering in the supine position.
Training continued with upper and lower extremity movements.
The intensity of the exercises was increased using different positions and elastic bands.
Stretching exercises and posture exercises were used during the cooling period.
All exercises were started with 10 repetitions and then increased to 20.
In order for the patients to perform the movements correctly, each movement was first demonstrated by the physiotherapist.
The movements that the patients could not do were applied by modifying them in a suitable way.
|
Active Comparator: Control Group
Breathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program.
They were asked to do the exercises 3 days a week for 8 weeks.
|
Breathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program.
They were asked to do the exercises 3 days a week for 8 weeks.
|
No Intervention: Evaluation of 'Core' Stability
"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.
|
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No Intervention: Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups.
|
|
No Intervention: Evaluation of Lower Extremity Functional Strength
Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test.
|
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No Intervention: Evaluation of Balance
Balance was evaluated using the Berg Balance Scale (BBS).
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|
No Intervention: Evaluation of Functional Mobility
Functional mobility was evaluated using the Timed Up and Go Test (TUG).
|
|
No Intervention: Evaluation of Functional Exercise Capacity
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).
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No Intervention: Activities of Daily Living and Evaluation of Motor Impairment
Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS).
|
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No Intervention: Evaluation of Freezing
The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance.
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No Intervention: Evaluation of Fatigue
Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16).
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No Intervention: Evaluation of Quality of Life
Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the Strength of "Core" Muscles
Time Frame: 8 weeks
|
The strength of the trunk muscles was evaluated with 'sit-up' and modified 'push-up' tests.
The number of times the subjects could perform each test for 30 seconds was recorded.
Each measurement was made twice and the best measurement was used in statistical analysis.
|
8 weeks
|
Evaluation of the Endurance of "Core" Muscles
Time Frame: 8 weeks
|
Static endurance of the "core" muscles was evaluated using the lateral bridge test defined by McGill, the trunk flexor endurance test and the "prone bridge" test.
The time in which the subjects could maintain the test position was recorded in seconds using a stopwatch.
Each measurement was made twice and the best measurement was used in statistical analysis.
The test was terminated if it disturbed the test position.
|
8 weeks
|
Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
Time Frame: 8 weeks
|
M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups.
Ultrasound recordings were made using B-mode ultrasound.
Each measurement was taken 3 times and the average value of 3 measurements was recorded in mm for statistical analysis.
|
8 weeks
|
Evaluation of Lower Extremity Functional Strength
Time Frame: 8 weeks
|
Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test.
The test was performed twice, one trial, and the last measurement was used in statistical analysis.
|
8 weeks
|
Evaluation of Balance
Time Frame: 8 weeks
|
Balance was evaluated using the Berg Balance Scale (BBS).
BBS tests were performed using the materials specified in the directive and in accordance with the instructions.
The total score ranges from 0-56, with higher scores indicating better balance.
|
8 weeks
|
Evaluation of Functional Mobility
Time Frame: 8 weeks
|
Functional mobility was evaluated using the Timed Up and Go Test (TUG).
This test; The duration was recorded and applied during the single-task and dual-task (motor and cognitive).
Testing for single task was carried out in accordance with the instruction.
In dual-motor duty, while holding an empty tray from the case with both hands; In the dual-cognitive task, he was asked to stand up and walk, turn around and come back and sit on the chair, counting 1 each backwards from a certain number (any number from 20 to 100).
The time was recorded with a stopwatch.
The test was performed twice, one trial, and the last measurement was used in statistical analysis.
|
8 weeks
|
Evaluation of Functional Exercise Capacity
Time Frame: 8 weeks
|
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). The test was performed in accordance with the American Thoracic Society criteria. Normal values of 6-MWT are calculated approximately according to age, gender, height and weight in healthy adults. In this study, using reference suggested by Gibbons et al. "Estimated 6-MWT distance" and the rate of reaching the maximal heart rate at the end of 6-MWT were calculated. |
8 weeks
|
Activities of Daily Living and Evaluation of Motor Impairment
Time Frame: 8 weeks
|
Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson's Disease Rating Scale (UPDRS).
The total score ranges from 0-108, with a higher score indicating a more serious disorder.
|
8 weeks
|
Evaluation of Freezing
Time Frame: 8 weeks
|
The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson's patients regarding the severity and effect of freezing on gait performance.
The total score ranges from 0-24, with a higher score meaning that a person's walking performance is more affected by freezing.
|
8 weeks
|
Evaluation of Fatigue
Time Frame: 8 weeks
|
Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16).
The total score ranged from 16 to 80, and a total of 8 points or more was considered tired.
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8 weeks
|
Evaluation of Quality of Life
Time Frame: 8 weeks
|
Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39).
This questionnaire is the most frequently used specific health status measure in PD patients.
The total score ranges from 0-100, and lower scores better reflect perceived quality of life.
|
8 weeks
|
Collaborators and Investigators
Investigators
- Study Director: DERYA CAGLAR, MSc, Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2019/10
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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