Trial Outcomes & Findings for The Energize! Study for Adults With Knee Replacement (NCT NCT06096727)
NCT ID: NCT06096727
Last Updated: 2026-03-27
Results Overview
Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
baseline to 3 months
Results posted on
2026-03-27
Participant Flow
Participant milestones
| Measure |
Energize!
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
23
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Energize! Study for Adults With Knee Replacement
Baseline characteristics by cohort
| Measure |
Energize!
n=27 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.0 years
STANDARD_DEVIATION 7.0 • n=56 Participants
|
66.8 years
STANDARD_DEVIATION 6.7 • n=62 Participants
|
68.0 years
STANDARD_DEVIATION 6.8 • n=123 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=56 Participants
|
19 Participants
n=62 Participants
|
40 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
10 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=56 Participants
|
23 Participants
n=62 Participants
|
50 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=56 Participants
|
23 Participants
n=62 Participants
|
46 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Actigraph assessed moderate-vigorous intensity physical activity
|
58.9 minutes/week
STANDARD_DEVIATION 53.1 • n=56 Participants
|
52.9 minutes/week
STANDARD_DEVIATION 73.9 • n=62 Participants
|
54.0 minutes/week
STANDARD_DEVIATION 61.3 • n=123 Participants
|
PRIMARY outcome
Timeframe: baseline to 3 monthsMinutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Minutes of Moderate to Vigorous Intensity Physical Activity
|
70.89 minutes/week
Standard Deviation 73.66
|
-7.71 minutes/week
Standard Deviation 25.77
|
PRIMARY outcome
Timeframe: baseline to 3 monthsPain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Pain Intensity
|
3.10 score on a scale
Standard Error 7
|
.22 score on a scale
Standard Error 4.81
|
PRIMARY outcome
Timeframe: baseline to 3 monthsPhysical 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.
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Self-reported Physical Function
|
45 t score
Standard Deviation 6.6
|
40.3 t score
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 3 months to 6 monthsMinutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Minutes/Week of Moderate to Vigorous Intensity Physical Activity
|
129.3 minutes/week
Standard Deviation 113.4
|
45.2 minutes/week
Standard Deviation 60.9
|
SECONDARY outcome
Timeframe: 3 months to 6 monthsPain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Pain Intensity
|
0.02 score on a scale
Standard Deviation 6.0
|
2.15 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 3 months to 6 monthsPhysical 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.
Outcome measures
| Measure |
Energize!
n=19 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=22 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Self-reported Physical Function
|
45.2 T score
Standard Deviation 6.8
|
40.1 T score
Standard Deviation 7.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNumber of video lessons viewed
Outcome measures
| Measure |
Energize!
n=27 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Adherence to Energize Program - Video Lessons Viewed
|
8.8 Videos watched
Standard Deviation 4.1
|
0 Videos watched
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNumber of weeks exercise minutes were planned or reported
Outcome measures
| Measure |
Energize!
n=27 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Adherence to Energize Program - Planning or Reporting Exercise Minutes
|
8.0 Number of weeks planned
Standard Deviation 4.5
|
0 Number of weeks planned
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsNumber of homework assignments completed
Outcome measures
| Measure |
Energize!
n=27 Participants
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 Participants
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Adherence to Energize Program - Homework Assignments
|
6.9 Number of homework assignments done
Standard Deviation 4.3
|
0 Number of homework assignments done
Standard Deviation 0
|
Adverse Events
Energize!
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Delayed Energize!
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Energize!
n=27 participants at risk
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 participants at risk
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hospitalization due to Hypokalemia
|
3.7%
1/27 • Number of events 1 • 6 months
adverse events
|
0.00%
0/23 • 6 months
adverse events
|
|
Musculoskeletal and connective tissue disorders
Septic arthritis
|
3.7%
1/27 • Number of events 1 • 6 months
adverse events
|
0.00%
0/23 • 6 months
adverse events
|
Other adverse events
| Measure |
Energize!
n=27 participants at risk
Participants randomized to Energize! will start the program immediately after baseline.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
Delayed Energize!
n=23 participants at risk
Participants randomized to Delayed Energize! will start the program after the 3 month assessment.
Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
fall
|
14.8%
4/27 • Number of events 4 • 6 months
adverse events
|
13.0%
3/23 • Number of events 3 • 6 months
adverse events
|
|
Gastrointestinal disorders
Hiatal hernia
|
3.7%
1/27 • Number of events 2 • 6 months
adverse events
|
4.3%
1/23 • Number of events 1 • 6 months
adverse events
|
|
Musculoskeletal and connective tissue disorders
Neck injury or strain
|
0.00%
0/27 • 6 months
adverse events
|
8.7%
2/23 • Number of events 2 • 6 months
adverse events
|
|
Musculoskeletal and connective tissue disorders
Shoulder injury/pain/surgery
|
11.1%
3/27 • Number of events 3 • 6 months
adverse events
|
4.3%
1/23 • Number of events 1 • 6 months
adverse events
|
|
Nervous system disorders
Cervical spinal fusion
|
0.00%
0/27 • 6 months
adverse events
|
4.3%
1/23 • Number of events 1 • 6 months
adverse events
|
|
Musculoskeletal and connective tissue disorders
Hip injury/surgery
|
3.7%
1/27 • Number of events 1 • 6 months
adverse events
|
4.3%
1/23 • Number of events 1 • 6 months
adverse events
|
|
Cardiac disorders
Atrial fibrilation
|
3.7%
1/27 • Number of events 1 • 6 months
adverse events
|
0.00%
0/23 • 6 months
adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Low oxygen levels
|
3.7%
1/27 • Number of events 1 • 6 months
adverse events
|
0.00%
0/23 • 6 months
adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place