NCT Number: NCT02825238
Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study
The purpose of this research is to develop and test the feasibility of an exercise intervention for persons with painful knee osteoarthritis involving the patella (kneecap). Participants in the patellofemoral osteoarthritis (PFOA) group will be treated with a 6-week supervised exercise program that targets strengthening the hip and trunk core muscles. Painfree control participants will attend one session to gather biomechanical, strength, and function data for use in comparison to the patellofemoral osteoarthritis group. Feasibility outcomes include adherence to the treatment program, recruitment, and retention. It is hypothesized that PFOA group participants will change score on a knee pain and function questionnaire by the minimum clinically important difference score for positive improvement at the end of the 6-week intervention program.
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Notify MeKey information
Conditions
Age range
35 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
University of Pennsylvania, Philadelphia, Pennsylvania, United States
About this study
The investigators propose to develop and test the feasibility of a 6-week supervised hip and core muscle exercise intervention for persons with painful patellofemoral osteoarthritis (PFOA), a common condition for middle-aged and older adults. Currently there is limited evidence regarding effective conservative interventions for PFOA, a chronic condition that is painful and limits function and quality of life. Exercise is recommended as a first-line treatment for knee osteoarthritis, but the optimal type of exercise for PFOA is unknown. This intervention is based upon similar programs shown to improve pain and function in younger persons with patellofemoral pain, a condition that may lead to PFOA. Feasibility outcomes include adherence to the treatment program, recruitment, retention, and the impact of the intervention on participants' pain and function at 6-weeks and 6 months after finishing the program. The investigators will also compare PFOA participants to a matched pain-free volunteer control group to explore the differences in their biomechanics, muscle strength, pain report, and function at baseline. Data from this feasibility study will be used to design a future randomized controlled trial investigating the efficacy of conservative exercise interventions for PFOA. The investigators' overarching goal is to develop a conservative exercise intervention that improves the symptoms, function, and quality of life of persons with PFOA.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Feasibility (adherence)
Time frame: 6 weeks
Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.
-
Feasibility (retention rates)
Time frame: 6 weeks
Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.
-
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.
-
Feasibility (recruitment rates)
Time frame: 4 years
Total number enrolled and total number screened out.
-
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).
-
Feasibility (follow-up response): exercise diary
Time frame: 6 months
Response to 6-month follow-up - return exercise diary (≥ 80% complete and return exercise diary): Percentage completion and return for diary.
-
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).
-
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).
Secondary outcomes
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Establish impact of intervention on physical performance
Time frame: 6 weeks
Change in score on Timed-Up-and-Go test.
-
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)
-
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)
Other outcomes
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Change in peak isometric muscle torque: hip abductors, hip extensors, hip external rotators, and knee extensors
Time frame: 6 weeks
-
Change in hip and knee joint biomechanics during step-down and sit-to-stand tasks
Time frame: 6 weeks
-
Change in KOOS symptoms subscale
Time frame: 6 weeks
-
Change in KOOS sport/recreation subscale
Time frame: 6 weeks
-
Change in KOOS quality of life subscale
Time frame: 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.
-
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).
-
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.
-
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.
Sponsors and collaborators
Lead sponsor
University of the Sciences in Philadelphia
Other
Collaborators
- Thomas Jefferson University
- University of Pennsylvania
Registry information
Official study title
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
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jul 7, 2016
- Registry last updated
- May 8, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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