NCT04063605

Brief Summary

Many studies showed that clinical pilates exercises has positive effects on static and dynamic balance of different populations. It was suggested that this type of exercise reduce the risk of falls and physical damage. It also helps prevention of kyphotic posture. Parkinson's patients have both balance and postural problems but no study investigated the effect of clinical pilates exercises for this population. The aim of this study is to investigate the effects of clinical pilates exercise program on postural control and balance in individuals with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

August 19, 2019

Last Update Submit

March 10, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • One leg stance test

    This test is used to measure balance and standing ability and gives an idea about the individual's ability to balance and the risk of falling. Test measures how many seconds the patient can stand on one leg.

    5 minutes

  • Tandem stance test

    It is a test that evaluates the static balance by narrowing the ground contact area. The heel of one foot is adjusted to the end of the other foot. Patient is asked to try to stand without loss of balance and the time is recorded in seconds.

    5 minutes

  • Functional reach test

    A balance test designed to measure stability limits. The patient is asked to raise the dominant arm 90 ° and place it at the shoulder level and extend as far as it can go forward, without loss of movement or balance in the feet. Reduced ability to reach indicates an increased risk of falling in the future.

    5 minutes

  • Sit-to-stand test

    This test evaluates the patient's sit-up activity, lower extremity strength and dynamic balance. The patient's number of sitting and getting up within 30 seconds gives the test score.

    5 minutes

  • Timed-up and Go test

    When the command is given, the patient gets up from a normal chair, walks 3 meters, turns and walks back to the chair and sits down. The time starts when the command is given and ends when the person sits back in the chair.

    5 minutes

  • Berg Balance Scale

    This test is used to measure a person's static and dynamic balance performance. It is effective in assessing postural control and predicting the risk of falling. It is a 14-item test that uses 0 to 4 sequential scoring for each item. The total score range is from 0 to 56 and a higher score indicates a better balance.

    15 minutes

Study Arms (2)

Clinical Pilates

EXPERIMENTAL

Participants in this group will receive twice a week, total 8 weeks of clinical pilates exercise program. Each session will take 45 minutes.

Other: Clinical Pilates

Classic Physiotherapy

ACTIVE COMPARATOR

Participants in this group will receive twice a week, total 8 weeks of classic physiotherapy exercise program. Each session will take 45 minutes.

Other: Classic Physiotherapy

Interventions

This exercise model focus on the awareness of the neutral position of the spine and strengthen the deep postural muscles of the spine. Training of trunk muscles is emphasized and trunk stabilization is achieved and more difficult activities are initiated and thus, body awareness is improved. There are general principles to be followed during exercises. These; The principle of concentration is respiration, central focus, control, stability and isolation. These principles are achieved by simultaneous muscle activation of muscles responsible for trunk stabilization (multifidus, diaphragm, transversus abdominis and pelvic floor muscles). In order for an exercise to become a clinical pilates exercise, trunk stabilization must be ensured and breath control should be established in each exercise.

Clinical Pilates

This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity.

Classic Physiotherapy

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 2-3 of Modified Hoehn \& Yahr Scale
  • or\> 26 points from the Mini Mental test
  • Having at least 2 years Parkinson Disease

You may not qualify if:

  • Serious mental and psychological disorder
  • Significant musculoskeletal disorders
  • Lower extremity deformation
  • Having another neurological disease
  • Drug or dose change during treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University of Lefke

Mersin, Turkey (Türkiye)

Location

Related Publications (3)

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  • Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  • Coban F, Belgen Kaygisiz B, Selcuk F. Effect of clinical Pilates training on balance and postural control in patients with Parkinson's disease: a randomized controlled trial. J Comp Eff Res. 2021 Dec;10(18):1373-1383. doi: 10.2217/cer-2021-0091. Epub 2021 Nov 2.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Beliz Belgen Kaygisiz, PT, PhD

    European University of Lefke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups will receive different exercise program for 8 weeks.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

September 16, 2019

Primary Completion

January 21, 2020

Study Completion

January 21, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations