Patellofemoral OsteoarthritisNCT02825238
Effect of Hip and Core Muscle Strengthening for Patellofemoral Osteoarthritis: A Feasibility Study
A study testing Supervised exercise program in people with Patellofemoral Osteoarthritis, run by University of the Sciences in Philadelphia at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- Supervised exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Oct 2012to 11 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of the Sciences
Philadelphia, Pennsylvania, 19104
About this study
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
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.
Read the 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.
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- Supervised exercise program
- Keywords
- exercise, osteoarthritis, knee, patellofemoral pain
- Medical subject headings
- Motor Activity, Osteoarthritis, Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group, did not undergo intervention. |
| Exercise group | Experimental | Experimental, exercise group, underwent intervention Receives: Other: Supervised exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (adherence)
Adherence to supervised program (≥ 80% complete 10 supervised exercise sessions and 2 data collection sessions): Percentage adherence.
Measured: 6 weeks
Feasibility (retention rates)
Completion of baseline and 6-week evaluation sessions. Percentage completion for both data collection sessions.
Measured: 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.
Measured: 6 months
Feasibility (recruitment rates)
Total number enrolled and total number screened out.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 6 weeks
Secondary outcomes (3)
Establish impact of intervention on physical performance
Change in score on Timed-Up-and-Go test.
Measured: 6 weeks
Determine long-term benefits of intervention: pain rating
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)
Measured: 6 months
Determine long-term benefits of intervention: activity of daily living rating
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start23 Oct 2012
- Primary completion11 Dec 2015
- Study completion11 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Thomas Jefferson University
- Responsible party
- Principal investigator, Lisa Hoglund, University of the Sciences in Philadelphia
- Investigators
- Lisa T Hoglund, PhD, PT, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825238
- Sponsor's protocol ID
- 297090
- Status last verified
- May 2018
- First submitted
- 29 Jun 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 29636983
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02825238
- Acronym / sponsor ID
- 297090
- Conditions
- Patellofemoral Osteoarthritis
- Keywords
- exercise, osteoarthritis, knee, patellofemoral pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Thomas Jefferson University
- Study start
- 23 Oct 2012 (actual)
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 11 Dec 2015 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group, did not undergo intervention. |
| Exercise group | Experimental | Other: Supervised exercise programExperimental, exercise group, underwent intervention |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise program | Other | Exercise group |
Primary outcome
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).
3 secondary outcomes
Establish impact of intervention on physical performance
Time frame: 6 weeks
Determine long-term benefits of intervention: pain rating
Time frame: 6 months
Determine long-term benefits of intervention: activity of daily living rating
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Results publication: PubMed 29636983Hoglund 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa T Hoglund, PhD, PT principal investigator
Thomas Jefferson University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise program in people with Patellofemoral Osteoarthritis, run by University of the Sciences in Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (adherence) (time frame: 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825238, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.