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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03711773
• Other study ID #: 2012532
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 1, 2030

Study information

• Verified date: November 2023
• Source: University of Missouri-Columbia
• Contact: Kylee Rucinski
• Phone: 573-884-6216
• Email: rucinskik[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Ankle
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BMI	Subjects will have routine weight measurements and BMI will be calculated	6 Months