NCT04619784

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

2.7 years

First QC Date

August 4, 2020

Last Update Submit

November 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

Secondary Outcomes (6)

  • Core stability

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

  • Musculoskeletal Pain

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

  • Quality of Life

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

  • Anxiety

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

  • Pain intensity

    Patients will be evaluated before treatment, 1 week after treatment, at the 3rd and 6th months after treatment

  • +1 more secondary outcomes

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Other: Pilates Exercises

Control Group

OTHER

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

Other: control

Interventions

Patients will receive 12 sessions of pilates.

Treatment Group
controlOTHER

Their routine medical treatments were continued

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Musculoskeletal or cognitive impairment at a level affecting evaluation and treatment
  • Other neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

August 4, 2020

First Posted

November 6, 2020

Study Start

April 16, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations