NCT04928833

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

3 months

First QC Date

April 27, 2021

Last Update Submit

June 9, 2021

Conditions

Keywords

Parkinson DiseasePilatesCore StabilityBalanceQuality of Life

Outcome Measures

Primary Outcomes (11)

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

Study Arms (12)

Pilates Group

EXPERIMENTAL

Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks.

Other: Pilates Training

Control Group

ACTIVE COMPARATOR

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.

Other: Control group

Evaluation of 'Core' Stability

NO INTERVENTION

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

Ultrasound Examination of M. Transversus Abdominus and M. Multifidus

NO INTERVENTION

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.

Evaluation of Lower Extremity Functional Strength

NO INTERVENTION

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

Evaluation of Balance

NO INTERVENTION

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

Evaluation of Functional Mobility

NO INTERVENTION

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

Evaluation of Functional Exercise Capacity

NO INTERVENTION

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

Activities of Daily Living and Evaluation of Motor Impairment

NO INTERVENTION

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).

Evaluation of Freezing

NO INTERVENTION

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.

Evaluation of Fatigue

NO INTERVENTION

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

Evaluation of Quality of Life

NO INTERVENTION

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

Interventions

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.

Pilates 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.

Control Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Standardized Mini Mental Test score is less than 24
  • Presence of cardiovascular, pulmonary, orthopedic or other medical conditions that limit participation in Pilates training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University

Güneysu, Rize Province, 53390, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Movement TechniquesControl Groups

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeuticsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • DERYA CAGLAR, MSc

    Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 27, 2021

First Posted

June 16, 2021

Study Start

November 1, 2019

Primary Completion

February 1, 2020

Study Completion

May 1, 2020

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations