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

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ClinicalTrials.gov Identifier: NCT03711773
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
James Cook, University of Missouri-Columbia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Osteoarthritis, Knee Osteoarthritis, Hip Osteoarthritis Ankle Other: Group Physical Therapy Classes Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcomes of Low-Impact Group Exercise Program for People With Ankle, Knee, and/or Hip Pain
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 1, 2030
Estimated Study Completion Date : January 1, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. VAS Pain scores [ Time Frame: 6 Months ]
    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.


Secondary Outcome Measures :
  1. BMI [ Time Frame: 6 Months ]
    Subjects will have routine weight measurements and BMI will be calculated


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711773


Contacts
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Contact: Kylee Rucinski 573-884-6216 rucinskik@health.missouri.edu
Contact: Stacee Clawson 573-884-3077 clawsons@health.missouri.edu

Locations
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United States, Missouri
Missouri Orthopaedic Institute Recruiting
Columbia, Missouri, United States, 65202
Contact: Kylee Rucinski    573-884-6216    rucinskik@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
More Information
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Responsible Party: James Cook, Professor, Orthopedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03711773    
Other Study ID Numbers: 2012532
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Cook, University of Missouri-Columbia:
joint pain
osteoarthritis
hip pain
knee pain
ankle pain
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases