Strength or Power Training for Patellofemoral Pain

NCT ID: NCT05403944

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-13
• Study Completion Date: 2027-09-30

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.

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.

Conditions

Patellofemoral Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard of Care (SOC)

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care Rehabilitation (SOC)

Intervention Type: BEHAVIORAL

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)

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.

Group Type: EXPERIMENTAL

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

Intervention Type: BEHAVIORAL

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.

Interventions

Standard of Care Rehabilitation (SOC)

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.

Intervention Type: BEHAVIORAL

Strength Training Rehabilitation Incorporating Power Exercises (STRIPE)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Central Florida

OTHER

Sponsor Role: collaborator

University of Toledo

OTHER

Sponsor Role: collaborator

University of Connecticut

OTHER

Sponsor Role: lead

Responsible Party

Neal Glaviano

Responsible Party

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neal Glaviano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

University of Connecticut

Storrs, Connecticut, United States

University of Central Florida

Orlando, Florida, United States

University of Toledo

Toledo, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36684710 (View on PubMed)

Other Identifiers

OR210126

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HR22-0038

Identifier Type: -

Identifier Source: org_study_id