The Energize! Study for Adults With Knee Replacement

NCT06096727 | Completed Results

• 1 other identifier: Pro00130186
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Arthroplasty

Keywords

physical activity

Outcome Measures

Primary Outcomes (3)

• Minutes of Moderate to Vigorous Intensity Physical Activity

  Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers

  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

  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.

  baseline to 3 months

Secondary Outcomes (3)

• Minutes/Week of Moderate to Vigorous Intensity Physical Activity

  3 months to 6 months

• Pain Intensity

  3 months to 6 months

• Self-reported Physical Function

  3 months to 6 months

Other Outcomes (3)

• Adherence to Energize Program - Video Lessons Viewed

  3 months

• Adherence to Energize Program - Planning or Reporting Exercise Minutes

  3 months

• Adherence to Energize Program - Homework Assignments

  3 months

Study Arms (2)

Energize!

EXPERIMENTAL

Participants randomized to Energize! will start the program immediately after baseline.

Behavioral: Energize!

Delayed Energize!

OTHER

Participants randomized to Delayed Energize! will start the program after the 3 month assessment.

Behavioral: Energize!

Interventions

Energize! BEHAVIORAL

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

Delayed Energize!; Energize!

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christine Pellegrini
• Organization: University of South Carolina

pellegca@mailbox.sc.edu

803-777-0911

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 24, 2023
• Study Start: October 24, 2023
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)