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Optimizing a Remote-based Physical Activity Intervention for Adults With Total Knee Replacement

Optimizing a Remote-based Physical Activity Intervention for Adults With Total Knee Replacement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06768762
Acronym
MOST Energized
Enrollment
336
Registered
2025-01-10
Start date
2025-01-21
Completion date
2029-07-31
Last updated
2026-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Replacement

Keywords

knee replacement, exercise, online

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.

Interventions

BEHAVIORALPhone Coaching

Participants will receive 11 coaching calls with a health coach. Calls will occur weekly during the first month, twice/month during months 2-3, and once/month during months 4-6. Each call is expected to last 10-15 minutes.

BEHAVIORALProgress reports to providers

Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.

BEHAVIORAL'Hear from Others' Videos

Participants will receive monthly 'Hear From Others' videos. The videos will include other adults with knee replacement discussing the challenges they have faced and strategies to overcome barriers to activity.

Participants will receive individualized feedback from a coach via email. The feedback will specifically focus on participant responses to the 'Apply Your Knowledge' activities and will correspond with the video lessons. Feedback will be weekly during months 1-3 and monthly during months 4-6.

MOST Energized! Online Exercise Program

Sponsors

University of South Carolina
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physical activity (min/week)Baseline to 6 monthsChange in Actigraph-assessed moderate-to-vigorous intensity physical activity
Percentage meeting physical activity guidelines6 monthsPercentage of participants meeting physical activity guidelines (150 minutes/week)

Secondary

MeasureTime frameDescription
Pain intensityBaseline to 6 monthsChange in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS)
Physical FunctionBaseline to 6 monthsChange in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS)

Countries

United States

Contacts

CONTACTJakob Nelson, MS
JAKOBRN@email.sc.edu803-766-6960
CONTACTChristine Pellegrini, PhD
pellegca@mailbox.sc.edu803-777-0911
PRINCIPAL_INVESTIGATORChristine Pellegrini, PhD

University of South Carolina

PRINCIPAL_INVESTIGATORJessica Unick, PhD

The Miriam Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 6, 2026