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Patellofemoral PainSTRIPENCT05403944

Strength or Power Training for Patellofemoral Pain

A study testing Strength Training Rehabilitation Incorporating Power Exercises (STRIPE) in people with Patellofemoral Pain, run by University of Connecticut at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Patellofemoral Pain
What is being tested?
Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
3 sitesUnited States
Study dates
13 Oct 2022to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants to be between the ages of 18-40 years old.
  • Insidious onset of symptoms greater than 3 months.
  • Worst pain in the previous month of 3/10 with two of the following tasks: prolonged sitting, jumping, squatting, kneeling, running, and stair ambulation.

Who cannot join

  • Other forms of anterior knee pain (Osgood-Schlatter, tendon pain, bursitis, etc.).
  • History of lower extremity surgery.
  • History of patella subluxation, meniscal injury or ligamentous instability.
  • History of referred pain from the lumbar spine.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • University of Central Florida

    Orlando, Florida, 32816

  • University of Connecticut

    Storrs, Connecticut, 06269

  • University of Toledo

    Toledo, Ohio, 43606

Other trials in United States

About this study

Official title: Optimizing Clinical Outcomes for Patients With Patellofemoral Pain Using Strength Training Rehabilitation Incorporating Power Exercises

The objective of this study is to compare a novel 6-week strength training rehabilitation incorporating power exercises (STRIPE) program to a standard of care (SOC) program on short-term and long-term pain, subjective function, patellofemoral pain recurrence rates, and secondary outcomes (hip abduction and extension rate of torque development and single-leg squat kinematics). We hypothesize that participants with patellofemoral pain who complete the STRIPE program will have 1) decreased pain, 2) improved subjective function, 3) reduced patellofemoral pain recurrence rates, 4a) improved hip abduction/extension rate of torque development, and 4b) decreased hip adduction and pelvic drop during a single leg squat compared to participants who complete a SOC rehabilitation program.

Read the detailed description

The proposed study will compare strength-based exercises, which is the standard of care (SOC), that target the hip abductors, hip extensors, lumbo-pelvic, and quadriceps muscles, to a strength training program that utilized power-based exercises (Strength Training Rehabilitation Incorporating Power Exercises [STRIPE]). Individuals with patellofemoral pain, both within the military and general population, present with long-term pain, decreased subjective function, and high recurrence rates. Our primary outcomes are to determine intervention success with self-reported knee pain, measured by the visual analog scale, subjective function, measured by the anterior knee pain scale, and recurrence rates. Recent evidence suggests that two in every three individuals with patellofemoral pain report symptoms up to two years after seeking care, therefore we will assess patellofemoral pain recurrence rates for two years. Additionally, the proposed interventions target gluteal muscle function, supporting our selection of secondary outcome variables. We will assess rate of torque development, as power-based exercises are recommended to improve muscle capacity, of both the targeted gluteus medius and gluteus maximus. We will also assess frontal plane kinematics, as the gluteal muscles are responsible for controlling pelvic and hip motion during functional tasks.

Being tested
Standard of Care Rehabilitation (SOC), Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care Rehabilitation (SOC)Behavioural

    6 weeks of standard of care rehabilitation will be given designed to target the core, hip, and quadriceps muscles. Each participant will be expected to complete 3 supervised telehealth sessions per week.

  • Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)Behavioural

    6 weeks of STRIPE rehabilitation will be given designed to target the core, hip, and quadriceps muscles. Each participant will be expected to complete 3 supervised telehealth sessions per week.

Study groups in NCT05403944
Study groupRoleWhat they receive
Standard of Care (SOC)Active comparatorThe SOC rehabilitation group will complete three strength sessions a week. All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles. The load magnitude for exercises will be between 60-70% of their 1 repetition max (1RM), with 3 sets of 12 repetitions and a 2-3-minute rest between sets. Time under tension will be prescribed as slow to moderate, with a 2-second concentric phase and 2-second eccentric phase for each exercise. Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.
Receives: Behavioral: Standard of Care Rehabilitation (SOC)
Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)ExperimentalThose in the STRIPE group will complete two power and one strength training sessions a week. All participants will be provided an educational pamphlet and exercises will be divided into four components - hip abductors, hip extensors, core, and quadriceps muscles. The load magnitude will be greater than 60% of the 1RM, with the goal of continually loading against heavy resistance. Participants will complete 4 sets of 6 repetitions, with 3-5 minutes of rest between sets. Time under tension will be prescribed as <1 second for the concentric phase and 1 second for the eccentric phase of the exercise. The strength training sessions will adhere to same parameters as the SOC. Hip abductor, hip extensor, and core exercises will be initiated during week 1 and continued for the 6-week intervention, while quadriceps focused exercises will be introduced in weeks 3-6.
Receives: Behavioral: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in knee pain.

    Data are presented as knee pain, assessed on the visual analog scale in centimeters, resulting in a score of 0-10, with 0 representing no pain and 10 being worst pain imaginable. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  2. Change in self-reported knee function.

    Data are presented as self-reported knee function, assessed by the anterior knee pain scale.

    The scale ranged between 0-100, with 0 indicating complete disability and 100 indicating no disability. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  3. Patellofemoral pain recurrence

    The number of patients who report symptoms of patellofemoral pain

    Measured: 6 months post intervention, 12-months post intervention, 18-months post intervention, and 24-months post intervention

  4. Change in hip rate of torque development

    Hip abduction and extension rate of torque development will be assessed with a handheld dynamometer. Data are reported as linear, with higher scores representing a faster ability to develop hip muscle force. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention.

  5. Change in hip adduction during a single leg squat

    Data are presented as a degree, with a higher number representing a higher amount of hip adduction. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  6. Change in pelvic drop during a single leg squat

    Data are presented as a degree, with a higher number representing a higher amount of pelvic drop. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

Secondary outcomes (5)
  1. Change in psychological factors

    Psychological factors will be measures with the PROMIS-10, a 10-item general self-reported questionnaire that assess general domains related to physical, mental, and social health, in addition to perceived quality of life. PROMIS-10 scores are standardized to the general population using a "T-Score", which is a score of 50 points and a standard deviation of 10-points. Higher scores on the PROMIS-10 indicate a healthier patient. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  2. Change in cognitive factors

    Cognitive factors will be assessed with the Fear-Avoidance Belief Questionnaire (FABQ), a dimension specific questionnaire. The FABQ contains two subscales - physical activity section that includes six-items, while the work section includes ten-items. The physical activity subscale score range between 0-24 and the work subscale is scored between 0-42. Higher scores identifying greater fear avoidance beliefs for both physical activity and work subscales. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  3. Change in coping strategy

    Coping strategies will be assessed with the Pain Self-Efficacy Questionnaire (PSEQ), a dimension specific questionnaire. The PSEQ is a ten-item, dimension specific questionnaire that assesses how confident participants are with performing activities while experiencing pain. Each item is rated on a scale ranging from 0 ("not at all confident") to 6 ("completely confident"). The PSEQ score ranges between 0-60, with a higher score representing higher confidence to function with pain. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  4. Change in physical activity

    Physical activity will be quantified with the International Physical Activity Questionnaire - Short Form (IPAQ-SF), a dimension specific questionnaire. The IPAQ-SF is a 4-item short form that measures physical activity from the previous 7-days. Questions include the number of days per week the participant engaged in vigorous activities, moderate activities, walking, and sitting, with a follow-up question for each asking for duration of time for each task. Group means and standard deviations will be reported.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

  5. Change in self-reported knee function

    The Knee Injury and Osteoarthritis Outcome Scale (KOOS) and the PFP subscale (KOOS-PF) will provide region and disease specific data throughout the study. The KOOS measures five separate dimensions; pain, symptoms, activities of daily living function, sports and recreational function, and quality of life. Each of the five domains are scored on a scale between 0-100, with lower scores representing greater impairments in self-reported function. The KOOS-PF subscale is an 11-item region specific questionnaire, ranging from 0-100, with greater scores also reflecting greater function.

    Measured: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start13 Oct 2022
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403944
Sponsor's protocol ID
HR22-0038
Other IDs
OR210126
Acronym
STRIPE
Status last verified
Apr 2026
First submitted
31 May 2022
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD data will be available on request after manuscript has been published.

Publications

  • Glaviano NR, Mangum LC, Bazett-Jones DM, DiStefano LJ, Toland MD, Boling M. Strength Training Rehabilitation Incorporating Power Exercises (STRIPE) for individuals with patellofemoral pain: a randomised controlled trial protocol. BMJ Open Sport Exerc Med. 2023 Jan 17;9(1):e001482. doi: 10.1136/bmjsem-2022-001482. eCollection 2023.

    PubMed 36684710

Questions about this trial

What is this clinical trial studying?

A study testing Strength Training Rehabilitation Incorporating Power Exercises (STRIPE) in people with Patellofemoral Pain, run by University of Connecticut at 3 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

This study is still under way. Results are not available in the source record yet.

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?

Change in knee pain. (time frame: Immediately after the intervention and then 6, 12, 18, and 24 months post-intervention.). The study lists 6 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 NCT05403944, 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 17 Apr 2026.

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