Outcomes of Low-Impact Exercise Program for People With Ankle, Knee, and/or Hip Pain

Outcomes of Low-Impact Group Exercise Program for People With Ankle, Knee, and/or Hip Pain

The primary objective of this study is to study how low-impact group exercise classes affect pain scores in patients with knee, hip, and ankle pain when paired with concurrent standard of care dietitian and behavioral health consults.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Osteoarthritis Ankle
• Intervention / Treatment: Other: Group Physical Therapy Classes

Detailed Description

Osteoarthritis is estimated to affect at least 10% of men and 13% of women over 60 years old in the United States. It's estimated roughly 1 million total joint replacements are being performed each year. Studies have suggested that for patients with knee pain that have high BMIs, low strength, and/or have not participated in conservative measures, a low-impact exercise plan when paired with diet counseling and behavioral health classes can improve patient reported outcomes scores in both pain and function. This study seeks to build upon this research and will provide low-impact exercise plans that will be paired with standard of care dietician and behavioral health interventions in order to offer patients a full-scope approach to battling osteoarthritis pain, especially for those with high BMIs, low strength, and/or for patients that have not attempted conservative therapy in the past. We will include patients with knee, hip, and ankle pain.

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kylee Rucinski; Phone Number: 573-884-6216; Email: rucinskik@health.missouri.edu
• Study Contact Backup: Name: Vicki Jones; Phone Number: 573-882-7583; Email: jonesvicki@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65202
      • Recruiting
      • Missouri Orthopaedic Institute
      • Contact: Kylee Rucinski; Phone Number: 573-884-6216; Email: rucinskik@health.missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 and over
• Ability to attend classes 3x weekly for 6 months with at least a 66% attendance rate
• Ability to concurrently attend standard of care dietitian and behavioral health classes for 6 months
• Joint pain (knee, ankle, hip)

Exclusion Criteria:

• Pregnant
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Physical Therapy Class; Group Physical Therapy Classes. Three times weekly, these subjects will have one hour group physical therapy sessions with either a physical therapist, physical therapy assistant, or personal trainer. These sessions will be aimed to improve strength and function in a low-impact setting designed specifically for those with joint pain.	Other: Group Physical Therapy Classes; Three times weekly, these subjects will have one hour group physical therapy sessions with either a physical therapist, physical therapy assistant, or personal trainer. These sessions will be aimed to improve strength and function in a low-impact setting designed specifically for those with joint pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Pain scores	Subjects will receive VAS pain surveys each group therapy class. These VAS pain scores (visual analog survey) are taken rated between 0, which is no pain, and 10, which is the most pain.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Subjects will have routine weight measurements and BMI will be calculated	6 Months

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: October 16, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: osteoarthritis; joint pain; knee pain; hip pain; ankle pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: 2012532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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