The Energize! Study for Adults With Knee Replacement

March 6, 2026 updated by: Christine A Pellegrini, PhD, University of South Carolina

Energize! Internet-Delivered Physical Activity Program for Adults With Knee Replacement

The purpose is to examine the effects of an online physical activity program on moderate to vigorous intensity physical activity, pain, and physical function in adults with knee replacement at 3 months (post-intervention) and 6 months (maintenance).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants with knee replacement will be randomized to start the online physical activity program (Energize!) either immediately or after 3 months. The online program consists of weekly physical activity goals, video lessons, action planning, and homework to help increase physical activity to 200 min/week. Assessments will be completed at baseline, 3 months, and 6 months.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Columbia, South Carolina, United States, 29208
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Have had a partial or total knee replacement ≥12 months ago
  • Have regular access to the internet
  • Willing to wear activity monitor for 7 days at baseline, 3 & 6 months
  • Engage in less than 60 minutes of self-reported moderate intensity exercise

Exclusion Criteria:

  • Have a mobility limiting comorbidity
  • Non-English speaking
  • Have a scheduled surgery within the next 6 months that would limit activity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Energize!
Participants randomized to Energize! will start the program immediately after baseline.
Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
Other: Delayed Energize!
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes of Moderate to Vigorous Intensity Physical Activity
Time Frame: baseline to 3 months
Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers
baseline to 3 months
Pain Intensity
Time Frame: baseline to 3 months
Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
baseline to 3 months
Self-reported Physical Function
Time Frame: baseline to 3 months
Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10.
baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minutes/Week of Moderate to Vigorous Intensity Physical Activity
Time Frame: 3 months to 6 months
Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days
3 months to 6 months
Pain Intensity
Time Frame: 3 months to 6 months
Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
3 months to 6 months
Self-reported Physical Function
Time Frame: 3 months to 6 months
Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10.
3 months to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Energize Program - Video Lessons Viewed
Time Frame: 3 months
Number of video lessons viewed
3 months
Adherence to Energize Program - Planning or Reporting Exercise Minutes
Time Frame: 3 months
Number of weeks exercise minutes were planned or reported
3 months
Adherence to Energize Program - Homework Assignments
Time Frame: 3 months
Number of homework assignments completed
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Actual)

September 10, 2024

Study Completion (Actual)

September 10, 2024

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 17, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00130186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

As this is a pilot study, we do not have a plan to share IPD.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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