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Investigation of the Effects of Pilates Training in Parkinson Patients

Primary Purpose

Parkinson Disease, Pilates, Core Stability

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pilates Training
Control group
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life

Eligibility Criteria

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

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

Sites / Locations

  • Recep Tayyip Erdogan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Active Comparator

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

No Intervention

Arm Label

Pilates Group

Control Group

Evaluation of 'Core' Stability

Ultrasound Examination of M. Transversus Abdominus and M. Multifidus

Evaluation of Lower Extremity Functional Strength

Evaluation of Balance

Evaluation of Functional Mobility

Evaluation of Functional Exercise Capacity

Activities of Daily Living and Evaluation of Motor Impairment

Evaluation of Freezing

Evaluation of Fatigue

Evaluation of Quality of Life

Arm Description

Pilates training was carried out as group exercises for about 1 hour, 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.

"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.

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.

Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test.

Balance was evaluated using the Berg Balance Scale (BBS).

Functional mobility was evaluated using the Timed Up and Go Test (TUG).

Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).

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 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.

Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16).

Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39).

Outcomes

Primary Outcome Measures

Evaluation of the Strength of "Core" Muscles
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.
Evaluation of the Endurance of "Core" Muscles
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.
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. 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.
Evaluation of Lower Extremity Functional Strength
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.
Evaluation of Balance
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.
Evaluation of Functional Mobility
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.
Evaluation of Functional Exercise Capacity
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.
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). The total score ranges from 0-108, with a higher score indicating a more serious disorder.
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. The total score ranges from 0-24, with a higher score meaning that a person's walking performance is more affected by freezing.
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). The total score ranged from 16 to 80, and a total of 8 points or more was considered tired.
Evaluation of Quality of Life
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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
June 9, 2021
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04928833
Brief Title
Investigation of the Effects of Pilates Training in Parkinson Patients
Official Title
Investigation of the Effects of Pilates Training in Parkinson Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital

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
This study was planned to examine the effects of Pilates training in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn & Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. It was concluded that Pilates training performed to Parkinson's patients 3 times a week for 8 weeks was effective on "core" stability, thickness of "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and QOL.
Detailed Description
This study was planned to examine the effects of Pilates training, which is a "core" stability based exercise method that improves body alignment, postural control and balance, on "core" stability, the thickness of the "core" muscles, functional exercise capacity, motor functions, freezing, fatigue and daily life activities (ADLs) in Parkinson's Patients. The study included 34 Parkinson's patients between Hoehn & Yahr Stage 1-2.5. The patients were randomly divided into two groups as as Pilates (n: 17) and control (n: 17). Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. The "core" power with the "sit-ups" and the modified "push-ups" tests, the "core" endurans with lateral bridge, trunk flexor endurance and "prone bridge" tests, the thickness of the "core" muscles by ultrasonography, functional strength of the lower limbs with 5 Times Sit Up Test (5TSST), balance with the Berg Balance Scale (BBS), functional mobility; with the Timed Up and Go Test (TUG), functional exercise capacity and walking with the 6-Minute Walk Test (6-MWT), motor impairment with the United Parkinson's Disease Rating Scale (UPDRS)-III, freezing with Freezing of Gait Questionnaire (FOGQ), fatigue with Parkinson's Fatigue Scale (PFS-16), ADLs with UPDRS-II, quality of life (QOL) with Parkinson's Disease Questionnaire-39 (PDQ-39) were evaluated before and after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life
Keywords
Parkinson Disease, Pilates, Core Stability, Balance, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Evaluation of 'Core' Stability
Arm Type
No Intervention
Arm Description
"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.
Arm Title
Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
Arm Type
No Intervention
Arm Description
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.
Arm Title
Evaluation of Lower Extremity Functional Strength
Arm Type
No Intervention
Arm Description
Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test.
Arm Title
Evaluation of Balance
Arm Type
No Intervention
Arm Description
Balance was evaluated using the Berg Balance Scale (BBS).
Arm Title
Evaluation of Functional Mobility
Arm Type
No Intervention
Arm Description
Functional mobility was evaluated using the Timed Up and Go Test (TUG).
Arm Title
Evaluation of Functional Exercise Capacity
Arm Type
No Intervention
Arm Description
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).
Arm Title
Activities of Daily Living and Evaluation of Motor Impairment
Arm Type
No Intervention
Arm Description
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).
Arm Title
Evaluation of Freezing
Arm Type
No Intervention
Arm Description
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.
Arm Title
Evaluation of Fatigue
Arm Type
No Intervention
Arm Description
Fatigue, one of the non-motor findings associated with Parkinson's, was evaluated with the Parkinson's Fatigue Scale-16 (PFS-16).
Arm Title
Evaluation of Quality of Life
Arm Type
No Intervention
Arm Description
Quality of Life was evaluated with Parkinson's Disease Questionnaire-39 (PDQ-39).
Intervention Type
Other
Intervention Name(s)
Pilates Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation of the Strength of "Core" Muscles
Description
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.
Time Frame
8 weeks
Title
Evaluation of the Endurance of "Core" Muscles
Description
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.
Time Frame
8 weeks
Title
Ultrasound Examination of M. Transversus Abdominus and M. Multifidus
Description
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.
Time Frame
8 weeks
Title
Evaluation of Lower Extremity Functional Strength
Description
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.
Time Frame
8 weeks
Title
Evaluation of Balance
Description
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.
Time Frame
8 weeks
Title
Evaluation of Functional Mobility
Description
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.
Time Frame
8 weeks
Title
Evaluation of Functional Exercise Capacity
Description
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.
Time Frame
8 weeks
Title
Activities of Daily Living and Evaluation of Motor Impairment
Description
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.
Time Frame
8 weeks
Title
Evaluation of Freezing
Description
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.
Time Frame
8 weeks
Title
Evaluation of Fatigue
Description
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.
Time Frame
8 weeks
Title
Evaluation of Quality of Life
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DERYA CAGLAR, MSc
Organizational Affiliation
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Recep Tayyip Erdogan University
City
Güneysu
State/Province
Ri̇ze
ZIP/Postal Code
53390
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Investigation of the Effects of Pilates Training in Parkinson Patients

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