Optimizing a Remote-based Physical Activity Intervention for Adults With Total Knee Replacement (MOST Energized)

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Replacement
• Intervention / Treatment: Behavioral: Phone Coaching; Behavioral: Progress reports to providers; Behavioral: 'Hear from Others' Videos; Behavioral: Individualized Feedback; Behavioral: Online exercise program

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.

• Study Type: Interventional
• Enrollment (Estimated): 336
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jakob Nelson, MS; Phone Number: 803-766-6960; Email: JAKOBRN@email.sc.edu
• Study Contact Backup: Name: Christine Pellegrini, PhD; Phone Number: 803-777-0911; Email: pellegca@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • University of South Carolina
      • Contact: Christine Pellegrini; Phone Number: 803-777-0911; Email: pellegca@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental condition 1; Energize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback	Behavioral: Phone 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.; Behavioral: Progress 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.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 2; Energize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos	Behavioral: Phone 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.; Behavioral: Progress 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 3; Energize Online Program plus phone coaching, progress reports to physicians, and individualized feedback	Behavioral: Phone 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.; Behavioral: Progress reports to providers; Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 4; Energize Online Program plus phone coaching and progress reports to physicians	Behavioral: Phone 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.; Behavioral: Progress reports to providers; Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 5; Energize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback	Behavioral: Phone 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.; 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.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 6; Energize Online Program plus phone coaching and 'Hear From Others' videos	Behavioral: Phone 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.; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 7; Energize Online Program plus phone coaching and individualized feedback	Behavioral: Phone 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.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 8; Energize Online Program plus phone coaching	Behavioral: Phone 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 9; Energize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback	Behavioral: Progress 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.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 10; Energize Online Program plus progress reports to physicians and 'Hear From Others' videos	Behavioral: Progress 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 11; Energize Online Program plus progress reports to physicians and individualized feedback	Behavioral: Progress reports to providers; Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 12; Energize Online Program plus progress reports to physicians	Behavioral: Progress reports to providers; Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 13; Energize Online Program plus 'Hear From Others' videos and individualized feedback	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.; Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 14; Energize Online Program plus 'Hear From Others' videos	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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 15; Energize Online Program plus individualized feedback	Behavioral: Individualized Feedback; 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.; Behavioral: Online exercise program; MOST Energized! Online Exercise Program
Experimental: Experimental condition 16; Energize Online Program	Behavioral: Online exercise program; MOST Energized! Online Exercise Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity (min/week)	Change in Actigraph-assessed moderate-to-vigorous intensity physical activity	Baseline to 6 months
Percentage meeting physical activity guidelines	Percentage of participants meeting physical activity guidelines (150 minutes/week)	6 months
Physical activity (min/week)	Change in Actigraph-assessed moderate-to-vigorous intensity physical activity	Baseline to 12 months
Percentage meeting physical activity guidelines	Percentage of participants meeting physical activity guidelines (150 minutes/week)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline to 6 months
Physical Function	Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline to 6 months
Pain intensity	Change in pain intensity using Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline to 12 months
Physical Function	Change in physical function using the physical function/mobility Patient-Reported Outcomes Measurement Information System (PROMIS)	Baseline to 12 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Jessica Unick, PhD, The Miriam Hospital; Principal Investigator: Christine Pellegrini, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2025
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): July 31, 2029

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; knee replacement; online
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: Pro00136251; R01AG088083 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be deposited into Zenodo at either the time of associated publication or the end of the performance period
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No