Optimizing a Remote-based Physical Activity Intervention for Adults With Total Knee Replacement
MOST Energized
2 other identifiers
interventional
336
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedStudy Start
First participant enrolled
January 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
May 5, 2026
April 1, 2026
3.9 years
January 6, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Pain intensity
Baseline to 6 months
Physical Function
Baseline to 6 months
Pain intensity
Baseline to 12 months
Physical Function
Baseline to 12 months
Study Arms (16)
Experimental condition 1
EXPERIMENTALEnergize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback
Experimental condition 2
EXPERIMENTALEnergize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos
Experimental condition 3
EXPERIMENTALEnergize Online Program plus phone coaching, progress reports to physicians, and individualized feedback
Experimental condition 4
EXPERIMENTALEnergize Online Program plus phone coaching and progress reports to physicians
Experimental condition 5
EXPERIMENTALEnergize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback
Experimental condition 6
EXPERIMENTALEnergize Online Program plus phone coaching and 'Hear From Others' videos
Experimental condition 7
EXPERIMENTALEnergize Online Program plus phone coaching and individualized feedback
Experimental condition 8
EXPERIMENTALEnergize Online Program plus phone coaching
Experimental condition 9
EXPERIMENTALEnergize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback
Experimental condition 10
EXPERIMENTALEnergize Online Program plus progress reports to physicians and 'Hear From Others' videos
Experimental condition 11
EXPERIMENTALEnergize Online Program plus progress reports to physicians and individualized feedback
Experimental condition 12
EXPERIMENTALEnergize Online Program plus progress reports to physicians
Experimental condition 13
EXPERIMENTALEnergize Online Program plus 'Hear From Others' videos and individualized feedback
Experimental condition 14
EXPERIMENTALEnergize Online Program plus 'Hear From Others' videos
Experimental condition 15
EXPERIMENTALEnergize Online Program plus individualized feedback
Experimental condition 16
EXPERIMENTALEnergize Online Program
Interventions
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 on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Carolinalead
- National Institute on Aging (NIA)collaborator
Study Sites (1)
University of South Carolina
Columbia, South Carolina, 29208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christine Pellegrini, PhD
University of South Carolina
- PRINCIPAL INVESTIGATOR
Jessica Unick, PhD
The Miriam Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 6, 2025
First Posted
January 10, 2025
Study Start
January 21, 2025
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
July 31, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
All data will be deposited into Zenodo at either the time of associated publication or the end of the performance period