Optimizing a Remote-based Physical Activity Intervention for Adults with Total Knee Replacement
NCT ID: NCT06768762
Last Updated: 2025-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
336 participants
INTERVENTIONAL
2025-01-21
2029-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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Experimental condition 1
Energize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback
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.
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
'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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 2
Energize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos
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.
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
'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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 3
Energize Online Program plus phone coaching, progress reports to physicians, and individualized feedback
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.
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 4
Energize Online Program plus phone coaching and progress reports to physicians
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.
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 5
Energize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback
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.
'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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 6
Energize Online Program plus phone coaching and 'Hear From Others' videos
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.
'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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 7
Energize Online Program plus phone coaching and individualized feedback
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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 8
Energize Online Program plus phone coaching
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 9
Energize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
'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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 10
Energize Online Program plus progress reports to physicians and 'Hear From Others' videos
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
'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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 11
Energize Online Program plus progress reports to physicians and individualized feedback
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 12
Energize Online Program plus progress reports to physicians
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 13
Energize Online Program plus 'Hear From Others' videos and individualized feedback
'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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 14
Energize Online Program plus 'Hear From Others' videos
'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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 15
Energize Online Program plus individualized feedback
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.
Online exercise program
MOST Energized! Online Exercise Program
Experimental condition 16
Energize Online Program
Online exercise program
MOST Energized! Online Exercise Program
Interventions
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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.
Progress reports to providers
Progress reports on physical activity and program adherence will be sent to participants providers at 3 and 6 months.
'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.
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.
Online exercise program
MOST Energized! Online Exercise Program
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
University of South Carolina
OTHER
Responsible Party
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Christine A Pellegrini, PhD
Associate Professor
Principal Investigators
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Christine Pellegrini, PhD
Role: PRINCIPAL_INVESTIGATOR
University of South Carolina
Jessica Unick, PhD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Locations
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University of South Carolina
Columbia, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00136251
Identifier Type: -
Identifier Source: org_study_id
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