Delaware Physical Exercise and Activity for Knee Osteoarthritis

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Behavioral: Brief Intervention
Behavioral: Expanded Intervention

Registration Number: NCT04980300

Lead Sponsor: University of Delaware

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

Inclusion Criteria

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;
have a history of knee pain for at least 12 weeks;
are interested in becoming more physically active;
have either a cell phone or laptop/desktop computer with broadband internet connection and working email address; and
are able to commit to the study for 12 weeks and willing to wear physical activity monitors
live in the contiguous United States
comfortable participating in a program delivered in English
is able to safely participate in a moderate-intensity exercise as determined by a pre-exercise screen questionnaire.

Exclusion Criteria

regularly exercise more than 60 minutes/week; or
has a scheduled knee or hip joint replacement; or
has had physical therapy for knee OA in the past 6 months; or
participated in a strength training program for the lower extremities in the past 6 months.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in Moderate-to-vigorous Intensity Physical Activity	Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome	Actigraph GT3X monitor to be worn over the right hip during waking hours. Participants will be instructed to wear the monitor for 7 consecutive days, and then return the monitor via mail in a pre-addressed, pre-stamped envelope that is provided. Units are in minutes/day of Moderate to vigorous intensity physical activity (MVPA), min 0, max 1440, with higher scores representing more time in MVPA

Secondary Outcome Measures

Name	Time	Method
Change in Treatment Beliefs of Physical Therapy: Positive	Baseline, 12 weeks, and 24 weeks	Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Change in Treatment Beliefs of Physical Exercise: Positive	Baseline, 12 weeks, and 24 weeks	Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Positive are on a scale of 7 to 28 with higher scores mean better outcome, i.e., more positive treatment beliefs
Change in Light Intensity Physical Activity (LPA)	Baseline, 12 weeks, and 24 weeks	Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in minutes/week of LPA between baseline and both follow-up timepoints. Minutes/day of LPA can range from 0 minutes/day to 1,440 minutes/day (24 hours x 60 minutes).
Change in Steps/Day	Baseline, 12 weeks, and 24 weeks	Data collected using the ActiGraph GT3x activity monitor will also be used to assess change in average steps/day between baseline and both follow-up timepoints. Steps/day can be any value greater than or equal to 0. Valid data includes those who wore the ActiGraph for \> 4 days.
Change in Treatment Beliefs of Physical Therapy: Negative	Baseline, 12 weeks, and 24 weeks	Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Therapy measure, which is a 9-item questionnaire that assesses health beliefs (positive and negative) related to physical therapy. Scores of the TOA PT Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs
Change in Treatment Beliefs of Physical Exercise: Negative	Baseline, 12 weeks, and 24 weeks	Participants will be asked to complete the treatment Beliefs of OA (TOA) Physical Exercise measure, which is a 13-item questionnaire that assesses health beliefs (positive and negative) related to physical activity. Scores of the TOA PE Negative are on a scale of 4 to 16 with higher scores mean worse outcome, i.e., more negative treatment beliefs