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

Primary Purpose

Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Group Physical Therapy Classes

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring joint pain, osteoarthritis, hip pain, knee pain, ankle pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Missouri Orthopaedic InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Group Physical Therapy Class

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BMI

Subjects will have routine weight measurements and BMI will be calculated

Full Information

NCT ID

NCT03711773

First Posted

October 16, 2018

Last Updated

November 16, 2022

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03711773

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2018 (Actual)

Primary Completion Date

January 1, 2030 (Anticipated)

Study Completion Date

January 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

joint pain, osteoarthritis, hip pain, knee pain, ankle pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group Physical Therapy Class

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Group Physical Therapy Classes

Intervention Description

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.

Primary Outcome Measure Information:

Title

VAS Pain scores

Description

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.

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

BMI

Description

Subjects will have routine weight measurements and BMI will be calculated

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kylee Rucinski

Phone

573-884-6216

rucinskik@health.missouri.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Stacee Clawson

Phone

573-884-3077

clawsons@health.missouri.edu

Facility Information:

Facility Name

Missouri Orthopaedic Institute

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kylee Rucinski

Phone

573-884-6216

rucinskik@health.missouri.edu

12. IPD Sharing Statement

Plan to Share IPD

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

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