Trial Outcomes & Findings for The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise (NCT NCT05561582)
NCT ID: NCT05561582
Last Updated: 2024-12-09
Results Overview
A digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
1 day
Results posted on
2024-12-09
Participant Flow
Participant milestones
| Measure |
High Intensity Exercise
Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Low Intensity Exercise
Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Quiet Rest
Participants will sit quietly for two minutes, three times.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Intensity on Exercise-Induced Hypoalgesia During a Knee Extension Exercise
Baseline characteristics by cohort
| Measure |
High Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Low Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Quiet Rest
n=20 Participants
Participants will sit quietly for two minutes, three times.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
20.89 years
STANDARD_DEVIATION 1.74 • n=5 Participants
|
21.50 years
STANDARD_DEVIATION 2.19 • n=7 Participants
|
21.60 years
STANDARD_DEVIATION 2.76 • n=5 Participants
|
21.36 years
STANDARD_DEVIATION 2.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Pressure Pain Threshold Quadriceps
|
496.16 kilopascals
STANDARD_DEVIATION 175.19 • n=5 Participants
|
499.83 kilopascals
STANDARD_DEVIATION 183.34 • n=7 Participants
|
459.58 kilopascals
STANDARD_DEVIATION 141.85 • n=5 Participants
|
485.19 kilopascals
STANDARD_DEVIATION 169.92 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayA digital pressure algometer will be applied to the quadriceps and upper trapezius for two trials each. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold). Participants will rate the pain experienced during the threshold testing using a 101-point numeric pain rate scale (NPRS) anchored with 0= no pain to 100= the most intense pain sensation imaginable immediately following each testing time.
Outcome measures
| Measure |
High Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Low Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Quiet Rest
n=20 Participants
Participants will sit quietly for two minutes, three times.
|
|---|---|---|---|
|
Pressure Pain Threshold
|
19.11 kilopascals
Standard Deviation 77.56
|
48.22 kilopascals
Standard Deviation 183.06
|
-4.14 kilopascals
Standard Deviation 88.66
|
SECONDARY outcome
Timeframe: 1 dayPressure pain threshold after an cold water immersion task will be measured.
Outcome measures
| Measure |
High Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 75% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Low Intensity Exercise
n=20 Participants
Participants will complete a knee extension exercise with weight equivalent to 30% of their 1-repetition maximum for 3 sets of 10 repetitions.
Seated knee extension exercise: Participants will be seated in a resistance exercise machine. Weight corresponding to the assigned group will be added to the machine. Participants will extend the dominant knee for 3 sets of 10 repetitions.
|
Quiet Rest
n=20 Participants
Participants will sit quietly for two minutes, three times.
|
|---|---|---|---|
|
Conditioned Pain Modulation
|
-34.44 kilopascals
Standard Deviation 98.43
|
-21.41 kilopascals
Standard Deviation 61.93
|
-54.03 kilopascals
Standard Deviation 79.56
|
Adverse Events
High Intensity Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low Intensity Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Quiet Rest
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place