Knee ArthroplastyNCT06096727

The Energize! Study for Adults With Knee Replacement

A study testing Energize! in people with Knee Arthroplasty, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Knee Arthroplasty
What is being tested?: Energize!
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2023to 10 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of South Carolina
Columbia, South Carolina, 29208

Other trials in United States

About this study

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

Read the 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.

Conditions: Knee Arthroplasty
Being tested: Energize!
Keywords: physical activity
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Energize!Behavioural
Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.

Study groups in NCT06096727
Study group	Role	What they receive
Energize!	Experimental	Participants randomized to Energize! will start the program immediately after baseline. Receives: Behavioral: Energize!
Delayed Energize!	Other	Participants randomized to Delayed Energize! will start the program after the 3 month assessment. Receives: Behavioral: Energize!

What is being measured

The primary outcome is the main question the study is designed to answer.

Minutes of Moderate to Vigorous Intensity Physical Activity
Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers
Measured: baseline to 3 months
Pain Intensity
Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
Measured: baseline to 3 months
Self-reported Physical Function
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.
Measured: baseline to 3 months

Secondary outcomes (3)

Minutes/Week of Moderate to Vigorous Intensity Physical Activity
Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days
Measured: 3 months to 6 months
Pain Intensity
Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
Measured: 3 months to 6 months
Self-reported Physical Function
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.
Measured: 3 months to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 202310 Sep 2024

First posted24 Oct 2023
Study start24 Oct 2023
Primary completion10 Sep 2024
Study completion10 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06096727
Sponsor's protocol ID: Pro00130186
Status last verified: Mar 2026
First submitted: 17 Oct 2023
Last updated: 27 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: As this is a pilot study, we do not have a plan to share IPD.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
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All Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Energize! Internet-Delivered Physical Activity Program for Adults With Knee Replacement
ClinicalTrials.gov ID: NCT06096727
Acronym / sponsor ID: Pro00130186
Conditions: Knee Arthroplasty
Keywords: physical activity
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of South CarolinaUniversity, hospital or other
Study start: 24 Oct 2023 (actual)
Primary completion: 10 Sep 2024 (actual)
Study completion: 10 Sep 2024 (actual)
First posted: 24 Oct 2023 (actual)
Results: Posted 27 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Energize!	Experimental	Behavioral: Energize!Participants randomized to Energize! will start the program immediately after baseline.
Delayed Energize!	Other	Behavioral: Energize!Participants randomized to Delayed Energize! will start the program after the 3 month assessment.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Energize!Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.	Behavioural	Delayed Energize!, Energize!

Primary outcome

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
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
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.

3 secondary outcomes

Minutes/Week of Moderate to Vigorous Intensity Physical Activity
Time frame: 3 months to 6 months
Pain Intensity
Time frame: 3 months to 6 months
Self-reported Physical Function
Time frame: 3 months to 6 months

Results and safety

Results posted to the registry on 27 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Energize!	27	19
Delayed Energize!	23	22

Primary outcome: Minutes of Moderate to Vigorous Intensity Physical Activity

Time frame: baseline to 3 months. Mean (Standard Deviation). Unit: minutes/week

Measure	Energize! n = 19	Delayed Energize! n = 22
Value	70.89 (73.66)	-7.71 (25.77)

Primary outcome: Pain Intensity

Time frame: baseline to 3 months. Mean (Standard Error). Unit: score on a scale

Measure	Energize! n = 19	Delayed Energize! n = 22
Value	3.10 (7)	.22 (4.81)

Primary outcome: Self-reported Physical Function

Time frame: baseline to 3 months. Mean (Standard Deviation). Unit: t score

Measure	Energize! n = 19	Delayed Energize! n = 22
Value	45 (6.6)	40.3 (7.5)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Energize!	2 of 27 (7.4%)	8 of 27 (29.6%)	0 of 27
Delayed Energize!	0 of 23 (0%)	6 of 23 (26.1%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. As this is a pilot study, we do not have a plan to share IPD.

Related trials for Knee Arthroplasty

Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
RecruitingPhase 2
A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation
Osteoarthritis, Knee
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Energize! in people with Knee Arthroplasty, run by University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Minutes of Moderate to Vigorous Intensity Physical Activity (time frame: baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06096727.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.