Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period

Clinical Efficacy of A Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period

The purpose of this study is to determine if a 10 week exercise rehabilitation program decreases anterior knee oain (PFPS) and improves function in patients with patellofemoral pain syndrome (PFPS). Individuals (age 18-50) with PFPS will be recruited to participate in this study to see if a 10 week exercise program focusing in core and hip strengthening, lower extremity strengthening foot intrinsic strengthening can decrease pain and increase function.

Study Overview

• Status: Completed
• Conditions: Patellar Femoral Syndrome
• Intervention / Treatment: Behavioral: 10 Week Exercise Program; Behavioral: DVD Program After 10 Weeks

Detailed Description

Patellofemoral pain syndrome (PFPS) is a very prevalent condition that presents in great number to patients in physician's offices and has a high recurrence rate. Physical therapy and exercise therapy to strengthen the quadriceps is often prescribed, however recurrence is common. It is hypothesized that PFPS patients have core weakness, hip strength abnormalities and neuromuscular control deficits.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals wishing to participate in study voluntarily
• Subjects diagnosed with patella-femoral syndrome. We will ascertain this by asking a few questions, which will not be recorded as they have not been enrolled in the study yet.
• Capable of following and completing a 10 week home exercise program

Exclusion Criteria:

• Individuals with prior knee surgery, tibial plateau fractures, known diagnosis of knee injuries such as meniscus or ligaments tears.
• Individuals unable to participate, i.e. cognitive deficits, weakness or functional deficits to upper extremities.
• Individuals unable to tolerate exercise program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home Exercises; Patients will be given a set of home exercises to perform as part of their rehabilitation home exercise program. They will be initially trained by a research team member and will be given a DVD home exercise video with instructions on how to perform the exercises.	Behavioral: 10 Week Exercise Program; Subjects will complete a 10 week exercise program using DVD with instructions provided. Participants will have to do one session of exercise on 5 different days each week for a total of 5 sessions per week, for 10 weeks.
Active Comparator: DVD Program; Weeks 1-10, subjects will not be prescribed exercise at home. If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants	Behavioral: DVD Program After 10 Weeks; If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kujala Scale for Anterior Knee Pain	13 item knee specific self report questionnaire that documents response to six activities thought to be associated specifically with anterior knee pain syndrome (walking, running, jumping, climbing stairs, squatting and sitting for prolonged periods with knees bent, as well as symptoms such as limp, inability to weight bear through affected the affected limb, swelling, abnormal patellar movement, muscle atrophy and limitation of knee flexion. The maximum score is 100 and lower scores indicate greater pain/disability.	10 Weeks

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Wayne Stokes, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2016
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 27, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 16, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: 12-00210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No