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The Energize! Study for Adults With Knee Replacement

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06096727
Enrollment
50
Registered
2023-10-24
Start date
2023-10-24
Completion date
2024-09-10
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Arthroplasty

Keywords

physical activity

Brief 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).

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.

Interventions

BEHAVIORALEnergize!

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

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Minutes of Moderate to Vigorous Intensity Physical Activitybaseline to 3 monthsMinutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers
Pain Intensitybaseline to 3 monthsPain 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 Functionbaseline to 3 monthsPhysical 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.

Secondary

MeasureTime frameDescription
Minutes/Week of Moderate to Vigorous Intensity Physical Activity3 months to 6 monthsMinutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days
Pain Intensity3 months to 6 monthsPain 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 Function3 months to 6 monthsPhysical 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.

Countries

United States

Baseline characteristics

Characteristic
Actigraph assessed moderate-vigorous intensity physical activity54.0 minutes/week
STANDARD_DEVIATION 61.3
Age, Continuous68.0 years
STANDARD_DEVIATION 6.8
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
46 Participants
Sex: Female, Male
Female
40 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 23
other
Total, other adverse events
8 / 276 / 23
serious
Total, serious adverse events
2 / 270 / 23

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026