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

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University of South Carolina

Status

Enrolling

Conditions

Knee Replacement

Treatments

Behavioral: Individualized Feedback
Behavioral: Progress reports to providers
Behavioral: Phone Coaching
Behavioral: 'Hear from Others' Videos
Behavioral: Online exercise program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06768762
Pro00136251
R01AG088083 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

336 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

336 participants in 16 patient groups

Experimental condition 1
Experimental group
Description:
Energize Online Program plus phone coaching, progress reports to physicians, 'Hear From Others' videos, and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Phone Coaching
Behavioral: Progress reports to providers
Behavioral: Individualized Feedback
Experimental condition 2
Experimental group
Description:
Energize Online Program plus phone coaching, progress reports to physicians, and 'Hear From Others' videos
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Phone Coaching
Behavioral: Progress reports to providers
Experimental condition 3
Experimental group
Description:
Energize Online Program plus phone coaching, progress reports to physicians, and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: Phone Coaching
Behavioral: Progress reports to providers
Behavioral: Individualized Feedback
Experimental condition 4
Experimental group
Description:
Energize Online Program plus phone coaching and progress reports to physicians
Treatment:
Behavioral: Online exercise program
Behavioral: Phone Coaching
Behavioral: Progress reports to providers
Experimental condition 5
Experimental group
Description:
Energize Online Program plus phone coaching, 'Hear From Others' videos, and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Phone Coaching
Behavioral: Individualized Feedback
Experimental condition 6
Experimental group
Description:
Energize Online Program plus phone coaching and 'Hear From Others' videos
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Phone Coaching
Experimental condition 7
Experimental group
Description:
Energize Online Program plus phone coaching and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: Phone Coaching
Behavioral: Individualized Feedback
Experimental condition 8
Experimental group
Description:
Energize Online Program plus phone coaching
Treatment:
Behavioral: Online exercise program
Behavioral: Phone Coaching
Experimental condition 9
Experimental group
Description:
Energize Online Program plus progress reports to physicians, 'Hear From Others' videos, and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Progress reports to providers
Behavioral: Individualized Feedback
Experimental condition 10
Experimental group
Description:
Energize Online Program plus progress reports to physicians and 'Hear From Others' videos
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Progress reports to providers
Experimental condition 11
Experimental group
Description:
Energize Online Program plus progress reports to physicians and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: Progress reports to providers
Behavioral: Individualized Feedback
Experimental condition 12
Experimental group
Description:
Energize Online Program plus progress reports to physicians
Treatment:
Behavioral: Online exercise program
Behavioral: Progress reports to providers
Experimental condition 13
Experimental group
Description:
Energize Online Program plus 'Hear From Others' videos and individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Behavioral: Individualized Feedback
Experimental condition 14
Experimental group
Description:
Energize Online Program plus 'Hear From Others' videos
Treatment:
Behavioral: Online exercise program
Behavioral: 'Hear from Others' Videos
Experimental condition 15
Experimental group
Description:
Energize Online Program plus individualized feedback
Treatment:
Behavioral: Online exercise program
Behavioral: Individualized Feedback
Experimental condition 16
Experimental group
Description:
Energize Online Program
Treatment:
Behavioral: Online exercise program

Trial contacts and locations

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Central trial contact

Christine Pellegrini, PhD; Jakob Nelson, MS

Data sourced from clinicaltrials.gov

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