NCT05811637

Brief Summary

This study aimed to investigate the effectiveness of Pilates exercises in Patellofemoral pain patients compared to hip and knee combined exercises in improving pain, muscle strength, flexibility, function and quality of life in short term.

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

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

March 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 13, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

March 31, 2023

Last Update Submit

November 16, 2024

Conditions

Keywords

Patellofemoral paincorequality of lifeexercisestrengthpilates

Outcome Measures

Primary Outcomes (2)

  • Functional assessment

    Kujala Anterior Knee Pain Scale is used to assess the functional disability levels of the patients.

    6 weeks

  • Pain assessment

    The numerical NPRS is used to measure and monitor the severity of pain. The patients will be asked to rate the severity of the current pain level between 0 and 10 (0 being "no pain" and 10 being the "worst imaginable pain").

    6 weeks

Secondary Outcomes (3)

  • Muscle strength assessment

    6 weeks

  • Muscle flexibility assessment

    6 weeks

  • Quality of life assessment

    6 weeks

Study Arms (2)

Supervised Rehabilitation

ACTIVE COMPARATOR

The supervised rehabilitation focused mainly on strengthening the hip-knee muscles and flexibility exercises for the gastrocnemius and hamstring muscles. Hip and knee targeted strengthening and stretching exercises will be applied for 6 weeks, two sessions a week 12 sessions of all exercises, 3 sets, and 10-15 repetitions of each set.

Other: Supervised Rehabilitation

Pilates Exercise

ACTIVE COMPARATOR

The principles of Pilates exercises will be taught to the patients in the first session, and the evaluation will be made. The exercises, including basic training exercises in the first week, will be performed for 6 weeks, each session lasting 45 minutes, two days a week, each exercise for 8-12 repetitions. The Pilates exercises, consisting of gradually increasing strengthening will be applied under the supervision of a physiotherapist.

Other: Pilates Exercise

Interventions

The program will be applied with the Pilates exercises every week. All patients were evaluated before and after the treatment (6 weeks).

Pilates Exercise

The program will be applied with the progression of the supervised rehabilitation in the 4th week

Supervised Rehabilitation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having characteristic signs of PFP (retropatellar or peripatellar pain)
  • Presence of at least 3 points of retropatellar or peripatellar pain on the Numbered Pain Rating Scale (NPRS) with squatting, climbing stairs, prolonged sitting, or functional activity that burdens the PFP
  • Presence of any of the criteria such as tenderness, small effusion in the patellar facet palpation

You may not qualify if:

  • Patellofemoral dislocation, subluxation, intra-articular knee pathology
  • Previous lower extremity surgery, and knee-related trauma
  • A history of hip pathology or neurological disorders
  • Knee trauma in the last 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patellofemoral Pain SyndromeMotor Activity

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized and trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 13, 2023

Study Start

April 15, 2023

Primary Completion

October 15, 2023

Study Completion

November 15, 2023

Last Updated

November 19, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations