Clinical trial NCT04980300: Delaware Physical Exercise and Activity for Knee Osteoarthritis
Official title: Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Physical Activity
Physical Therapy
Telehealth
Strengthening Exercise
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 103
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Moderate-to-vigorous Intensity Physical Activity
timeFrame: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome
Secondary outcomes:
measure: Change in Treatment Beliefs of Physical Therapy: Positive
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Treatment Beliefs of Physical Exercise: Positive
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Light Intensity Physical Activity (LPA)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Steps/Day
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Treatment Beliefs of Physical Therapy: Negative
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Change in Treatment Beliefs of Physical Exercise: Negative
timeFrame: Baseline, 12 weeks, and 24 weeks
Other outcomes:
measure: Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Exploratory Outcome: Change in Treatment Expectations
timeFrame: Baseline and after randomization
measure: Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)
timeFrame: 12 weeks and 24 weeks
measure: Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale
timeFrame: Baseline, 12 weeks, and 24 weeks
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
Study officials:
References: