NCT04183933

Brief Summary

The aim of this study was to evaluate and compare the effects of Clinical Pilates Exercise Training and Combined Exercise Training on balance and functional status in individuals with knee Osteoarthritis (OA).

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

2 months

First QC Date

November 29, 2019

Last Update Submit

December 9, 2019

Conditions

Osteo Arthritis KneeBalance

Outcome Measures

Primary Outcomes (1)

  • Fullerton Advanced Balance Scale (FAB-T)

    It is a test that determines the functional balance state of individuals. The test has 10 parameters. These are: feet adjacent and eyes closed standing, reaching out forward to reach a shoulder-length object, 360 degrees of turning in right and left directions, stepping and passing over a 15.24 cm-long stair, tandem march, standing on one leg, eyes closed staying on the foam, double feet bounce, walking with head turning, reactive postural control. In this scale, which is scored between 0-40, a score between 0 and 4 is given for each item.

    Change will be assessed from the baseline at 1 week and 6th week

Secondary Outcomes (8)

  • Berg Balance Test

    Evaluation will be applied on the first day and after 6 weeks

  • The Timed Up & Go (TUG) Test

    Change will be assessed from the baseline at 1 week and 6th week

  • Single Leg Stance Test on Hard Ground

    Change will be assessed from the baseline at 1 week and 6th week

  • Single Leg Stance Test on Foam Ground

    Change will be assessed from the baseline at 1 week and 6th week

  • Push and Release Test

    Change will be assessed from the baseline at 1 week and 6th week

  • +3 more secondary outcomes

Study Arms (2)

Pilates Exercise Group

ACTIVE COMPARATOR

Pilates exercises will given for 6 weeks, 3 days in a week.

Other: Pilates Exercise

Combined Exercise group

ACTIVE COMPARATOR

Combined exercises will given for 6 weeks, 3 days in a week.

Other: Combined Exercise

Interventions

Pilates ExerciseOTHER

Pilates exercises will be given for 6 weeks, 3 days in a week.

Pilates Exercise Group
Combined ExerciseOTHER

Combined exercise will be given for 6 weeks, 3 days in a week.

Combined Exercise group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals diagnosed with knee osteoarthritis II-III level according to the results of radiological evaluation by Kellgren and Lawrence
  • Individuals aged between 40 and 70 years
  • Individuals who have pain in his/her either of the knees in 3 month period and who have a VAS score of 3 or more
  • Individuals who can walk 10 meters independently (with or without ancillary device)

You may not qualify if:

  • Individuals with Body Mass Index 35 and above
  • Individuals with a history of surgery or injury involving the lower limb within the last 1 year (knee / hip endoprosthesis, post-fracture surgery, menisectomy, etc.)
  • Individuals who received hyaluronic acid or corticosteroid injections in the last year
  • People with severe eyesight, hearing disabilities Individuals with neurological deficit or disorder
  • Individuals with regular exercise habits in the last 6 months
  • Individuals with inflammatory rheumatic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 99628, Cyprus

RECRUITING

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Gozde Iyigun, Asst. Prof

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

  • Sevim Oksuz, Asst. Prof

    Eastern Mediterranean University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Berkiye Kırmızıgil, Asst. Prof

CONTACT

03926303067berkiyekirmizigil@yahoo.com

Ender Angin, Asst. Prof

CONTACT

03926303067ender.angin@emu.edu.tr

Study Design

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

Study Record Dates

First Submitted

November 29, 2019

First Posted

December 3, 2019

Study Start

December 9, 2019

Primary Completion

January 24, 2020

Study Completion

February 10, 2020

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations

CY(1)