Delaware Physical Exercise and Activity for Knee Osteoarthritis

Browse trials for

• Osteoarthritis 4,398
• Osteoarthritis, Knee 3,302

Keywords

• Physical Activity
• Physical Therapy
• Telehealth
• Strengthening Exercise

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 103 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Lead sponsor

University of Delaware is the lead sponsor of 125 studies on the registry; 23 are open to participants now.

Study arms

• Experimental
  Intervention

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

  Behavioral: Intervention

• Active comparator
  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.

  Behavioral: Control

Interventions

• BehavioralIntervention

  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.

• BehavioralControl

  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

   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

   Time frame: Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome

Secondary outcomes

1. Change in Treatment Beliefs of Physical Therapy: Positive

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

2. Change in Treatment Beliefs of Physical Exercise: Positive

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

3. Change in Light Intensity Physical Activity (LPA)

   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).

   Time frame: Baseline, 12 weeks, and 24 weeks

4. Change in Steps/Day

   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.

   Time frame: Baseline, 12 weeks, and 24 weeks

5. Change in Treatment Beliefs of Physical Therapy: Negative

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

6. Change in Treatment Beliefs of Physical Exercise: Negative

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

Other outcomes

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

3. Exploratory Outcome: Change in Treatment Expectations

   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.

   Time frame: Baseline and after randomization

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

   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.

   Time frame: 12 weeks and 24 weeks

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

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

   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

   Time frame: Baseline, 12 weeks, and 24 weeks

Baseline characteristics

Study documents

• Protocol and informed consent form · Jul 14, 2023
• Statistical analysis plan · Jul 2, 2024

Documents are hosted by the registry — open the source record to download them.