The Energize! Study for Adults With Knee Replacement

Sponsor
University of South Carolina (Other)
Overall Status
Recruiting
CT.gov ID
NCT06096727
Collaborator
(none)
50
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Energize!
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Energize! Internet-Delivered Physical Activity Program for Adults With Knee Replacement
Actual Study Start Date :
Oct 24, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Energize!

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

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

Other: Delayed Energize!

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

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

Outcome Measures

Primary Outcome Measures

  1. Minutes of moderate to vigorous intensity physical activity [baseline to 3 months]

    activity assessed by Actigraph accelerometers

  2. 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

  3. 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.

Secondary Outcome Measures

  1. Minutes of moderate to vigorous intensity physical activity [3 months to 6 months]

    activity assessed by Actigraph accelerometers

  2. 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

  3. 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.

Other Outcome Measures

  1. Adherence to Energize program - video lessons viewed [3 months]

    Number of video lessons viewed

  2. Adherence to Energize program - planning or reporting exercise minutes [3 months]

    Number of weeks exercise minutes were planned or reported

  3. Adherence to Energize program - homework assignments [3 months]

    Number of homework assignments completed

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Carolina Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christine A Pellegrini, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT06096727
Other Study ID Numbers:
  • Pro00130186
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 27, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christine A Pellegrini, PhD, Assistant Professor, University of South Carolina

Study Results

No Results Posted as of Oct 27, 2023