- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06096727
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
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.
Sponsor
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
Keywords
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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