The Energize! Study for Adults With Knee Replacement

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06096727
• Other study ID #: Pro00130186
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: September 2024

Study information

• Verified date: March 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to Energize program - video lessons viewed	Number of video lessons viewed	3 months
Other	Adherence to Energize program - planning or reporting exercise minutes	Number of weeks exercise minutes were planned or reported	3 months
Other	Adherence to Energize program - homework assignments	Number of homework assignments completed	3 months
Primary	Minutes of moderate to vigorous intensity physical activity	activity assessed by Actigraph accelerometers	baseline to 3 months
Primary	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
Primary	Self-reported physical function	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.	baseline to 3 months
Secondary	Minutes of moderate to vigorous intensity physical activity	activity assessed by Actigraph accelerometers	3 months to 6 months
Secondary	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	3 months to 6 months
Secondary	Self-reported physical function	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.	3 months to 6 months