- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02825238
Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study
The Effect of Hip and Core Muscle Strengthening on Pain, Function, Quality of Life and Movement Patterns in Persons With Patellofemoral Osteoarthritis: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of the Sciences
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patellofemoral Osteoarthritis group: 1) age 35-70 years, 2) have been diagnosed with knee osteoarthritis in one or both knees with symptoms primarily in the anterior knee, 3) radiographic evidence of ≥ Grade 1 osteophytes or joint space narrowing at the patellofemoral joint according to the Osteoarthritis Research Society International (OARSI) grading scale (0 = none, 1 = mild/possible, 2 = moderate/definite, 3 = severe), 4) pain produced by ≥ 2 of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, increased activity (e.g., hiking), morning stiffness < 30 minutes, stiffness after sitting ≥ 30 minutes, history of patellar subluxation or dislocation in the past.
Control group: 1) age 35-70 years, 2) no known diagnosis by a physician of knee osteoarthritis, 3) pain free in the lower extremities at the time of enrollment into the study and for 1 week prior to enrollment.
Exclusion Criteria:
Patellofemoral Osteoarthritis (PFOA) group: 1) the presence of other conditions that may cause knee pain (e.g., patellar tendonitis, rheumatoid arthritis), 2) neurologic or musculoskeletal conditions that may alter lower extremity kinematics (e.g., multiple sclerosis, hip arthritis/arthroplasty), 3) history of a fracture of the knee, 4) pregnancy, 5) knee injections within the past 3 months, 6) inability to understand English.
Control group: 1) all previously listed exclusion criteria for the PFOA group, 2) knee pain produced by 2 or more of the following: descending steps, ascending steps, sit-to-stand, squatting, kneeling, prolonged knee flexion, or a history of patellar subluxation or dislocation in the past.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Control group, did not undergo intervention.
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EXPERIMENTAL: Exercise group
Experimental, exercise group, underwent intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility (adherence)
Time Frame: 6 weeks
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Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.
|
6 weeks
|
Feasibility (retention rates)
Time Frame: 6 weeks
|
Completion of baseline and 6-week evaluation sessions.
Percentage completion for both data collection sessions.
|
6 weeks
|
Feasibility (follow-up response): questionnaire
Time Frame: 6 months
|
Response to 6-month follow-up - return Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire (≥ 80% complete and return KOOS): Percentage completion and return for KOOS.
|
6 months
|
Feasibility (recruitment rates)
Time Frame: 4 years
|
Total number enrolled and total number screened out.
|
4 years
|
Feasibility (establish viability of underlying treatment model): global rating of change
Time Frame: 6 weeks
|
Response to participation in intervention program in terms of overall rating of change (≥ 80% will achieve Global Rating of Change score ≥ 3 [scale -5 to 5] - positive numbers indicate positive change).
|
6 weeks
|
Feasibility (follow-up response): exercise diary
Time Frame: 6 months
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Response to 6-month follow-up - return exercise diary (≥ 80% complete and return exercise diary): Percentage completion and return for diary.
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6 months
|
Feasibility (establish viability of underlying treatment model): pain rating
Time Frame: 6 weeks
|
Response to participation in intervention program in terms of pain rating (≥ 80% will change score on KOOS pain subscale by the minimum clinically important difference score for positive improvement [positive change of 10 points] - at the end of the 6-week intervention program).
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6 weeks
|
Feasibility (establish viability of underlying treatment model): activity of daily living rating
Time Frame: 6 weeks
|
Response to participation in intervention program in terms of activity of daily living rating (≥ 80% will change score on KOOS activity of daily living (ADL) subscale by the minimum clinically important difference score for positive improvement [positive change of 10 points] - at the end of the 6-week intervention program).
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Establish impact of intervention on physical performance
Time Frame: 6 weeks
|
Change in score on Timed-Up-and-Go test.
|
6 weeks
|
Determine long-term benefits of intervention: pain rating
Time Frame: 6 months
|
Change in score of KOOS pain subscale score for positive improvement: 6-month follow-up KOOS versus baseline KOOS scores (more positive scores equals lower pain level)
|
6 months
|
Determine long-term benefits of intervention: activity of daily living rating
Time Frame: 6 months
|
Change in score of KOOS ADL subscale score for positive improvement: 6-month follow-up KOOS versus baseline KOOS scores (more positive scores equals better function in activities of daily living)
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6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in peak isometric muscle torque: hip abductors, hip extensors, hip external rotators, and knee extensors
Time Frame: 6 weeks
|
6 weeks
|
|
Change in hip and knee joint biomechanics during step-down and sit-to-stand tasks
Time Frame: 6 weeks
|
6 weeks
|
|
Change in KOOS symptoms subscale
Time Frame: 6 weeks
|
6 weeks
|
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Change in KOOS sport/recreation subscale
Time Frame: 6 weeks
|
6 weeks
|
|
Change in KOOS quality of life subscale
Time Frame: 6 weeks
|
6 weeks
|
|
Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of lower extremity biomechanics (joint angles)
Time Frame: 6 weeks
|
Lower extremity peak joint angles will be measured with a motion capture system during functional activities.
|
6 weeks
|
Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of lower extremity muscle torque
Time Frame: 6 weeks
|
Lower extremity peak isometric torque will be measured with a dynamometer (force gauge).
|
6 weeks
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Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of physical performance on the Timed-Up-and Go test
Time Frame: 6 weeks
|
Time to perform the Timed-Up-and-Go test of walking ability will be measured with a stop watch.
|
6 weeks
|
Examine differences between patellofemoral osteoarthritis group and painfree control group in terms of symptoms on the Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time Frame: 6 weeks
|
Responses to the KOOS questionnaire will be gathered and the score calculated.
|
6 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa T Hoglund, PhD, PT, Thomas Jefferson University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 297090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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