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Completed

NCT Number: NCT06096727

The Energize! Study 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).

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Key information

Conditions

Knee Arthroplasty Behavior Motor Activity

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energize!

Behavioral

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

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. 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. 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.

Other outcomes

  1. Adherence to Energize Program - Video Lessons Viewed

    Time frame: 3 months

    Number of video lessons viewed

  2. Adherence to Energize Program - Planning or Reporting Exercise Minutes

    Time frame: 3 months

    Number of weeks exercise minutes were planned or reported

  3. Adherence to Energize Program - Homework Assignments

    Time frame: 3 months

    Number of homework assignments completed

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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