Clinical trial NCT06768762: Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement
Official title: Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Replacement
Keywords: knee replacement
exercise
online
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-10
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

Detailed description: All participants will receive a 6-month, fully automated online behavioral exercise program (Energize! Exercise Program). This program is designed to increase moderate-intensity physical activity among individuals who engage in little to no physical activity at baseline. Over the course of the program, participants are given a physical activity goal which starts at 75 minutes per week and gradually progresses to 200 minutes per week. Participants are instructed to view a 10-15-minute video lesson weekly, during months 1-3, and monthly during months 4-6. These lessons teach behavioral principles for increasing exercise and maintaining physical activity long-term. Participants are also asked to complete an 'Apply Your Knowledge' activity after watching each video lesson. These activities are designed to help the participant engage more with the lesson content, with a particular emphasis on applying the content to their lives. Within this program, participants are also asked to plan and report their exercise each week, and automated feedback is provided based upon their weekly physical activity reports.

In addition to receiving the Energize! Exercise Program, participants will be randomly assigned to receive 0-4 supplemental intervention components (phone coaching, progress reports to providers, 'Hear From Others' videos, and individualized feedback) which are each described in more detail below.

Eligibility criteria: Inclusion Criteria:

* had a knee replacement (including primary, staged or independent bilateral, or revision) at least 12 months ago
* have a computer, tablet, or smartphone with active internet access
* self-report engaging in less than 60 minutes/week of moderate-intensity physical activity
* be English-speaking and able to read consent and study materials written in English
* be willing to complete the 4 remote assessments, including physical activity monitoring
* be willing to be randomized to receive 0-4 supplemental intervention components.

Exclusion Criteria:

* any contraindications to physical activity (e.g., chest pain)
* have a scheduled surgery within the next 12 months (e.g., hip or knee replacement)
* have a mobility limiting comorbidity unrelated to knee replacement
* live outside of the continental U.S
* do not currently have a physician or orthopedic surgeon whom they see regularly
* are currently participating in physical therapy (for knee)
* are participating in a structured weight loss or physical activity program
* unable to provide proof of knee replacement surgery
* have a BMI \>40kg/m2
* score \>30 on PROMIS cognitive function

Primary outcomes:
measure: Physical activity (min/week)
timeFrame: Baseline to 6 months
measure: Percentage meeting physical activity guidelines
timeFrame: 6 months
measure: Physical activity (min/week)
timeFrame: Baseline to 12 months
measure: Percentage meeting physical activity guidelines
timeFrame: 12 months
Secondary outcomes:
measure: Pain intensity
timeFrame: Baseline to 6 months
measure: Physical Function
timeFrame: Baseline to 6 months
measure: Pain intensity
timeFrame: Baseline to 12 months
measure: Physical Function
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Christine Pellegrini, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Jessica Unick, PhD
role: PRINCIPAL_INVESTIGATOR
References: