NCT05403944

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Oct 2022Sep 2027

First Submitted

Initial submission to the registry

May 31, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

May 31, 2022

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

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

  • 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.

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

  • Patellofemoral pain recurrence

    The number of patients who report symptoms of patellofemoral pain

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

  • 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.

    Immediately after the intervention.

  • 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.

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

  • 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.

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

Secondary Outcomes (5)

  • Change in psychological factors

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

  • Change in cognitive factors

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

  • Change in coping strategy

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

  • Change in physical activity

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

  • Change in self-reported knee function

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

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

The 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.

Behavioral: Standard of Care Rehabilitation (SOC)

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

EXPERIMENTAL

Those 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.

Behavioral: Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Interventions

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.

Standard of Care (SOC)

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.

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Central Florida

Orlando, Florida, 32816, United States

Location

University of Toledo

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Neal Glaviano, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Responsible Party

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 3, 2022

Study Start

October 13, 2022

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

IPD data will be available on request after manuscript has been published.

Locations