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Completed

NCT Number: NCT04980300

Delaware Physical Exercise and Activity for Knee Osteoarthritis

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meet the National Institute for Health and Care Excellence Osteoarthritis (NICE) clinical criteria:
  • being at least 45 years of age;
  • having activity-related joint pain;
  • 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.

Treatment and study plan

Intervention

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

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.

Primary outcomes

  1. Change in Moderate-to-vigorous Intensity Physical Activity

    Time frame: 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 outcomes

  1. Change in Treatment Beliefs of Physical Therapy: Positive

    Time frame: 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

  2. Change in Treatment Beliefs of Physical Exercise: Positive

    Time frame: 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

  3. Change in Light Intensity Physical Activity (LPA)

    Time frame: 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).

  4. Change in Steps/Day

    Time frame: 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.

  5. Change in Treatment Beliefs of Physical Therapy: Negative

    Time frame: 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

  6. Change in Treatment Beliefs of Physical Exercise: Negative

    Time frame: 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

Other outcomes

  1. Exploratory Outcome: Change in Knee Pain (Visual Analogue Scale)

    Time frame: Baseline, 12 weeks, and 24 weeks

    Change in knee pain will be measured using a single-item Visual Analog Scale (VAS) question in which the participant will indicate their pain in each knee. Scores range from 0-100 where 0 is no pain and 100 is the worst pain imaginable. An index knee to be used for analysis is defined as the knee with worse pain at baseline.

    Scores of the Knee pain Visual Analogue Scale are on a scale of 0 to 100 with higher scores mean worse outcome, i.e., more pain

  2. Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Pain Subscale

    Time frame: Baseline, 12 weeks, and 24 weeks

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.

    KOOS Pain, min 0, max 100, with higher scores representing a better outcome

  3. Exploratory Outcome: Change in Treatment Expectations

    Time frame: Baseline and after randomization

    The participant will complete a Treatment Expectations Question, which asks the participant how effective they expect the intervention to be for their knee. This question will be collected at the baseline timepoint: right before and right after randomization. Answers will be expressed as frequencies and percentages for each of the following categories: No effect at all, Minimal improvement, Moderate improvement, Large improvement, and Complete recovery, as well as reported as an increase, decrease, or no change in treatment expectations.

    Score ranges from 1 to 5 with higher scores representing higher expectations of improvement following treatment.

  4. Exploratory Outcome: Change in Exercise Adherence Rating Scale (EARS)

    Time frame: 12 weeks and 24 weeks

    For the Expanded Intervention, adherence to strengthening exercises and physical activity will be measured using the Exercise Adherence Rating Scale (EARS). The EARS includes 6 items whose total score ranges from 0 to 24, where a higher score indicates greater adherence.

  5. Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Symptoms Subscale

    Time frame: Baseline, 12 weeks, and 24 weeks

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.

    KOOS Symptoms, min 0, max 100, with higher scores representing a better outcome

  6. Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) ADL Subscale

    Time frame: Baseline, 12 weeks, and 24 weeks

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.

    KOOS ADL, min 0, max 100, with higher scores representing a better outcome

  7. Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Sports and Recreation Subscale

    Time frame: Baseline, 12 weeks, and 24 weeks

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.

    KOOS Sports and Recreation, min 0, max 100, with higher scores representing a better outcome

  8. Exploratory Outcome: Change in Knee Injury and OA Outcome Score (KOOS) Quality of Life Subscale

    Time frame: Baseline, 12 weeks, and 24 weeks

    The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a 42-item questionnaire that assesses five domains, including pain, symptoms (other than pain), function in activities of daily living, function in sport and recreation, and quality of life. The KOOS has subscale scores for Pain, Symptoms, ADL Function, Sport & Recreation Function, and Quality of Life. Scores are transformed to a 0-100 scale with 0 indicating extreme knee problems and 100 indicating no knee problems.

    KOOS Quality of Life, min 0, max 100, with higher scores representing a better outcome

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Registry information

Official study title

Delaware Physical Exercise and Activity for Knee Osteoarthritis (PEAK)

Acronym: PEAK

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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