Delaware Physical Exercise and Activity for Knee Osteoarthritis

NCT ID: NCT04980300

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2023-06-01

Brief Summary

The objective of this project is to examine the efficacy of an innovative Telehealth Physical Therapy (PT) program for adults with knee osteoarthritis (OA) to increase physical activity over 12 weeks in adults with knee OA compared to a control group receiving web-based resources about knee OA. One hundred individuals with knee osteoarthritis (OA), who are over the age of 45, and are also looking to move more, will be randomized into a brief or expanded intervention group. The control includes an online, guided video orientation from a physical therapist to web resources for strengthening exercises, physical activity, and pain management strategies for knee OA. The intervention includes up to 5 online consultations with a physical therapist over a 12-week period who will prescribe strengthening exercises, physical activity goals, and pain management strategies for knee OA.

Detailed Description

Delaware PEAK (Physical therapy Exercise and Activity for Knee osteoarthritis) is a delivered remotely by a physical therapist over 5 one-on-one video conference (Zoom Platform) consultations lasting 45 to 60 minutes each over 12 weeks. Each consultation focuses on strengthening exercises, physical activity goals, and education to debunk common OA-related myths and misconceptions. Delaware PEAK utilizes a well-established behavioral counseling method, Motivational Interviewing, to increase self-efficacy (confidence) related to exercise, while delivering all aspects of the intervention.

The objective of this project is to examine the efficacy of Delaware PEAK to increase physical activity in adults with knee OA compared to a control group receiving web-based resources about knee OA and exercise. The rationale for our study is that there is a need to examine whether PEAK can directly target the mismatch between OA recommendations and practice patterns. Our central hypothesis is that Delaware PEAK will increase physical activity and will increase the belief that exercise is helpful and not harmful, compared with a control group receiving web-based OA treatment resources. Successful completion of this proposal will provide the evidence necessary to scale up this low-cost intervention, with the goal of increasing the number of adults who use exercise to manage their knee OA and thus reducing the burden of disease.

The primary endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase MVPA over 12 weeks compared to a control group receiving web-based resources about knee OA and exercise.

The secondary analyses endpoint of our study is to examine the efficacy of a physical therapist-delivered exercise intervention (Delaware PEAK) to increase health beliefs in Physical Exercise and Physical Therapy, light physical activity (LPA), and steps per day, over 24 weeks compared to a control group receiving web-based resources about knee OA and exercise. We also will assess change in MVPA over 24 weeks.

Our exploratory endpoints include change in pain, symptoms, function in activities of daily living, function in sport and recreation, and quality of life over 12 weeks and 24 weeks. We will also examine change in treatment expectations before and after randomization. Lastly, we will examine change in treatment adherence from 12 to 24 weeks among those in the expanded intervention group.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Virtual consultation sessions with a physical therapist, focusing on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis.

Group Type: EXPERIMENTAL

Intervention

Intervention Type: BEHAVIORAL

Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.

Control

Web-based resources on knee osteoarthritis, including an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.

Interventions

Intervention

Participants in the Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.

Intervention Type: BEHAVIORAL

Control

Participants in the Control arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:

1. being at least 45 years of age;

2. having activity-related joint pain;

3. having morning stiffness ≤ 30 minutes;

2. have a history of knee pain for at least 12 weeks;

3. are interested in becoming more physically active;

4. have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and

5. are able to commit to the study for 12 weeks and willing to wear physical activity monitors

6. live in the contiguous United States

7. comfortable participating in a program delivered in English

8. is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire.

Exclusion Criteria

1. regularly exercise more than 60 minutes/week; or

2. has a scheduled knee or hip joint replacement; or

3. has had physical therapy for knee OA in the past 6 months; or

4. participated in a strength training program for the lower extremities in the past 6 months.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

References

Aily JB, Copson J, Voinier D, Jakiela J, Hinman R, Grosch M, Noonan C, Armellini M, Schmitt L, White M, White D. Understanding Recruitment Yield From Social Media Advertisements and Associated Costs of a Telehealth Randomized Controlled Trial: Descriptive Study. J Med Internet Res. 2023 May 18;25:e41358. doi: 10.2196/41358.

Reference Type: DERIVED

PMID: 37200067 (View on PubMed)

Jakiela JT, Voinier D, Hinman RS, Copson J, Schmitt LA, Leonard TR, Aily JB, Bodt BA, White DK. Comparing an Expanded Versus Brief Telehealth Physical Therapist Intervention for Knee Osteoarthritis: Study Protocol for the Delaware PEAK Randomized Controlled Trial. Phys Ther. 2023 Feb 1;103(2):pzac139. doi: 10.1093/ptj/pzac139.

Reference Type: DERIVED

PMID: 36200390 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1730922

Identifier Type: -

Identifier Source: org_study_id