The Energize! Study for Adults with Knee Replacement

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Behavioral: Energize!

• Registration Number: NCT06096727
• Lead Sponsor: University of South Carolina

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.

Study Timeline

• Study First Submitted: 2023-10-17
• Study First Submitted QC: 2023-10-17
• Study Start: 2023-10-24
• Study First Posted: 2023-10-24
• Primary Completion: 2024-09-10
• Study Completion: 2024-09-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Energize!	Energize!	Participants randomized to Energize! will start the program immediately after baseline.
Delayed Energize!	Energize!	Participants randomized to Delayed Energize! will start the program after the 3 month assessment.

Primary Outcome Measures

Name	Time	Method
Self-reported physical function	baseline to 3 months	Physical function assessed by Patient-Reported Outcomes Measurement Information System physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function.
Minutes of moderate to vigorous intensity physical activity	baseline to 3 months	activity assessed by Actigraph accelerometers
Pain intensity	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

Secondary Outcome Measures

Name	Time	Method
Minutes of moderate to vigorous intensity physical activity	3 months to 6 months	activity assessed by Actigraph accelerometers
Self-reported physical function	3 months to 6 months	Physical function assessed by Patient-Reported Outcomes Measurement Information System physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function.
Pain intensity	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

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States