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Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study

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ClinicalTrials.gov Identifier: NCT02825238
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
University of Pennsylvania
Thomas Jefferson University
Information provided by (Responsible Party):
Lisa Hoglund, University of the Sciences in Philadelphia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Patellofemoral Osteoarthritis Other: Supervised exercise program Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 23, 2012
Actual Primary Completion Date : December 11, 2015
Actual Study Completion Date : December 11, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Control group, did not undergo intervention.
Experimental: Exercise group
Experimental, exercise group, underwent intervention
Other: Supervised exercise program



Primary Outcome Measures :
  1. Feasibility (adherence) [ Time Frame: 6 weeks ]
    Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.

  2. Feasibility (retention rates) [ Time Frame: 6 weeks ]
    Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.

  3. 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.

  4. Feasibility (recruitment rates) [ Time Frame: 4 years ]
    Total number enrolled and total number screened out.

  5. 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. 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.

  7. 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).

  8. 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 Outcome Measures :
  1. Establish impact of intervention on physical performance [ Time Frame: 6 weeks ]
    Change in score on Timed-Up-and-Go test.

  2. 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)

  3. 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 Outcome Measures:
  1. Change in peak isometric muscle torque: hip abductors, hip extensors, hip external rotators, and knee extensors [ Time Frame: 6 weeks ]
  2. Change in hip and knee joint biomechanics during step-down and sit-to-stand tasks [ Time Frame: 6 weeks ]
  3. Change in KOOS symptoms subscale [ Time Frame: 6 weeks ]
  4. Change in KOOS sport/recreation subscale [ Time Frame: 6 weeks ]
  5. Change in KOOS quality of life subscale [ Time Frame: 6 weeks ]
  6. 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.

  7. 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).

  8. 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.

  9. 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.



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825238


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of the Sciences
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of the Sciences in Philadelphia
University of Pennsylvania
Thomas Jefferson University
Investigators
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Principal Investigator: Lisa T Hoglund, PhD, PT Thomas Jefferson University
Additional Information:
Publications of Results:
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Responsible Party: Lisa Hoglund, Associate Professor, University of the Sciences in Philadelphia
ClinicalTrials.gov Identifier: NCT02825238    
Other Study ID Numbers: 297090
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lisa Hoglund, University of the Sciences in Philadelphia:
exercise
osteoarthritis
knee
patellofemoral pain
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases