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NCT Number: NCT06768762

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

Location status: Recruiting

Location contact

Christine Pellegrini

CONTACT

[email protected]

803-777-0911

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Phone Coaching

Behavioral

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.

Progress reports to providers

Behavioral

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

'Hear from Others' Videos

Behavioral

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.

Individualized Feedback

Behavioral

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.

Online exercise program

Behavioral

MOST Energized! Online Exercise Program

Primary outcomes

  1. Physical activity (min/week)

    Time frame: Baseline to 6 months

    Change in Actigraph-assessed moderate-to-vigorous intensity physical activity

  2. Percentage meeting physical activity guidelines

    Time frame: 6 months

    Percentage of participants meeting physical activity guidelines (150 minutes/week)

  3. Physical activity (min/week)

    Time frame: Baseline to 12 months

    Change in Actigraph-assessed moderate-to-vigorous intensity physical activity

  4. Percentage meeting physical activity guidelines

    Time frame: 12 months

    Percentage of participants meeting physical activity guidelines (150 minutes/week)

Secondary outcomes

  1. Pain intensity

    Time frame: Baseline to 6 months

    Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS)

  2. Physical Function

    Time frame: Baseline to 6 months

    Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS)

  3. Pain intensity

    Time frame: Baseline to 12 months

    Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS)

  4. Physical Function

    Time frame: Baseline to 12 months

    Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS)

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Pellegrini, PhD

CONTACT

[email protected]

803-777-0911

Jakob Nelson, MS

CONTACT

[email protected]

803-766-6960

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: MOST Energized

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 10, 2025
Registry last updated
May 5, 2026

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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