Strength Training in Female Runners With Patellofemoral Pain

NCT04480528 | Completed

• 1 other identifier: 54348
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patellofemoral pain (PFP) is a common running-related injury that is often referred to as runner's knee. The condition typically presents with pain in the front of the knee that is located around or behind the knee cap. This injury occurs twice as frequently in females and is often associated with weakness of the muscles of the thigh and hip, as well as altered running form. Heavy-weight strength training is needed in order to improve muscle weakness; however, this puts a significant amount of load on the knee joint and it is difficult for individuals with PFP to train at this level without experiencing increased pain and joint discomfort. Blood flow restriction training (BFRT) is a promising alternative method to safely improve muscle weakness while reducing knee joint loading. With BFRT, a pressurized band is applied to the thigh in order to partially restrict blood flow as a patient exercises in order to decrease the amount of oxygen delivered to the muscle. Lack of oxygen to the muscle combined with strength training creates an environment within the muscle that results in the ability of low-weight strength training to provide the same results as heavy-weight strength training. This study will evaluate how low-weight strength training with and without BFRT affects thigh and hip strength, and consequently pain, function, running ability, and running form in female runners with PFP. The hypothesis is that 10 weeks of low-weight strength training with BFRT will lead to greater thigh and hip strength, reduced pain, improved knee function, improved running ability, and improved running form compared to low-weight strength training without BFRT. The expected results will have a significant impact within the running community by providing a safe and effective treatment that increases strength and improves running form while reducing pain and joint loading. This will also have an impact on the larger field of sports medicine by providing an alternative method to improve strength, as well as improve function when heavy-weight strength training is not well tolerated or unsafe due to injury.

Conditions

Patellofemoral Syndrome

Keywords

Blood Flow Restriction; Running; Patellofemoral Pain

Outcome Measures

Primary Outcomes (5)

• Change in Isometric Quadriceps Strength

  The subject will be seated in a Biodex 4 dynamometer with their knee locked at 90 degrees of flexion. The subject will be asked to kick into the dynamometer pad as hard as they can and the peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.

  10 weeks

• Change in Isokinetic Quadriceps Strength

  The subject will be seated in a Biodex 4 dynamometer and be asked to kick back-and-forth into the dynamometer pad as hard and as fast as they can. The peak force will be measured and normalized to body weight. Increased force indicates greater quadriceps strength.

  10 weeks

• Change in Isometric Hip Abduction Strength

  The subject will be lying in the side-lying position with a stabilizing strap placed around the thigh. The subject will be asked to press out as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip abduction strength.

  10 weeks

• Change in Isometric Hip Extension Strength

  The subject will be lying on their stomach with their knee flexed to 90 degrees and a stabilizing strap placed around the thigh. The subject will be asked to press up as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip extension strength.

  10 weeks

• Change in Isometric Hip External Rotation Strength

  The subject will be seated with their knee flexed to 90 degrees and a stabilizing strap placed around the lower leg. The subject will be asked to press inward as hard as they can against a handheld dynamometer which records the force applied against it. The peak force will be measured and normalized to body weight. Increased force indicates greater hip external rotation strength.

  10 weeks

Secondary Outcomes (7)

• Change in Hip Adduction Angle

  10 weeks

• Change in Hip Internal Rotation Angle

  10 weeks

• Change in Peak Knee Extensor Moment

  10 weeks

• Change in Pain: Brief Pain Inventory (BPI)

  10 weeks

• Change in Patellofemoral Pain: Knee Injury and Osteoarthritis Outcome Score

  10 weeks

Study Arms (2)

BFRT Group

EXPERIMENTAL

This group will receive physical therapy plus active BFRT.

Other: Blood Flow Restriction Training (BFRT)

Standard of Care Group

SHAM COMPARATOR

This group will receive physical therapy plus sham BFRT.

Other: Sham Blood Flow Restriction Training (Sham BFRT)

Interventions

Blood Flow Restriction Training (BFRT) OTHER

A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.

BFRT Group

Sham Blood Flow Restriction Training (Sham BFRT) OTHER

A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.

Standard of Care Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pain around (peripatellar) or behind (retropatellar) the patella, which is aggravated by running and at least one other activity that loads the patellofemoral joint during weight bearing on a flexed knee such as kneeling, squatting, stair ambulation, and jumping/hopping
• Insidious onset of symptoms unrelated to trauma
• Pain present for at least 2 months
• Pain rating of at least 3/10 on the visual analog scale during running
• Report running at least 10 miles per week currently or just prior to onset of injury
• Score a maximum of 85% on either the Knee Outcome Survey Activities of Daily Living Scale or Sports Activity Scale (KOS-ADL or KOS-SAS)

You may not qualify if:

• Knee pain resulting from acute trauma
• Concurrent ligamentous instability, meniscus pathology, patellar or iliotibial band tendinopathy
• History of patellar dislocations or instability, or previous reconstructive surgery to the knee
• Other lower extremity or lower back injury within the past 6 months

Sponsors & Collaborators

• Lauren Erickson: lead
• American College of Sports Medicine: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Lauren Erickson, DPT

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: June 8, 2020
• Primary Completion: November 13, 2021
• Study Completion: November 13, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)