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

NCT02825238 | Completed

• 1 other identifier: 297090
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Patellofemoral Osteoarthritis

Keywords

exercise; osteoarthritis; knee; patellofemoral pain

Outcome Measures

Primary Outcomes (8)

• Feasibility (adherence)

  Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.

  6 weeks

• Feasibility (retention rates)

  Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.

  6 weeks

• Feasibility (follow-up response): questionnaire

  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)

  Total number enrolled and total number screened out.

  4 years

• Feasibility (establish viability of underlying treatment model): global rating of change

  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

  Response to 6-month follow-up - return exercise diary (≥ 80% complete and return exercise diary): Percentage completion and return for diary.

  6 months

• Feasibility (establish viability of underlying treatment model): pain rating

  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).

  6 weeks

• Feasibility (establish viability of underlying treatment model): activity of daily living rating

  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 Outcomes (3)

• Establish impact of intervention on physical performance

  6 weeks

• Determine long-term benefits of intervention: pain rating

  6 months

• Determine long-term benefits of intervention: activity of daily living rating

  6 months

Other Outcomes (9)

• Change in peak isometric muscle torque: hip abductors, hip extensors, hip external rotators, and knee extensors

  6 weeks

• Change in hip and knee joint biomechanics during step-down and sit-to-stand tasks

  6 weeks

• Change in KOOS symptoms subscale

  6 weeks

Study Arms (2)

Control

NO INTERVENTION

Control group, did not undergo intervention.

Exercise group

EXPERIMENTAL

Experimental, exercise group, underwent intervention

Other: Supervised exercise program

Interventions

Supervised exercise program OTHER

Exercise group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Sciences in Philadelphia: lead
• University of Pennsylvania: collaborator
• Thomas Jefferson University: collaborator

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of the Sciences

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Hoglund LT, Pontiggia L, Kelly JD 4th. A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study. Pilot Feasibility Stud. 2018 Apr 6;4:70. doi: 10.1186/s40814-018-0262-z. eCollection 2018.

  PMID: 29636983 RESULT

Related Links

• A 6-week hip muscle strengthening and lumbopelvic-hip core stabilization program to improve pain, function, and quality of life in persons with patellofemoral osteoarthritis: a feasibility pilot study.

MeSH Terms

Conditions

Motor Activity; Osteoarthritis; Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Lisa T Hoglund, PhD, PT

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 7, 2016
• Study Start: October 23, 2012
• Primary Completion: December 11, 2015
• Study Completion: December 11, 2015
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)