Delaware Physical Exercise and Activity for Knee Osteoarthritis

NCT04980300 | Completed Results DMC

• 1 other identifier: 1730922
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Physical Activity; Physical Therapy; Telehealth; Strengthening Exercise

Outcome Measures

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

  Baseline to 12 weeks as primary outcome Baseline to 24 weeks as secondary outcome

Secondary Outcomes (6)

• Change in Treatment Beliefs of Physical Therapy: Positive

  Baseline, 12 weeks, and 24 weeks

• Change in Treatment Beliefs of Physical Exercise: Positive

  Baseline, 12 weeks, and 24 weeks

• Change in Light Intensity Physical Activity (LPA)

  Baseline, 12 weeks, and 24 weeks

• Change in Steps/Day

  Baseline, 12 weeks, and 24 weeks

• Change in Treatment Beliefs of Physical Therapy: Negative

  Baseline, 12 weeks, and 24 weeks

Other Outcomes (8)

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

  Baseline, 12 weeks, and 24 weeks

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

  Baseline, 12 weeks, and 24 weeks

• Exploratory Outcome: Change in Treatment Expectations

  Baseline and after randomization

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

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.

Intervention

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.

Control

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (2)

• 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.

  PMID: 37200067 DERIVED

• 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.

  PMID: 36200390 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Motor Activity

Interventions

Methods

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Daniel White
• Organization: University of Delaware

dkw@udel.edu

302-831-7607

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2021
• First Posted: July 28, 2021
• Study Start: July 3, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: January 1, 2025
• Results First Posted: January 1, 2025

Record last verified: 2024-04

Locations

US (1)