Trial Outcomes & Findings for Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises (NCT NCT01576159)
NCT ID: NCT01576159
Last Updated: 2015-06-10
Results Overview
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Baseline and 12 weeks
Results posted on
2015-06-10
Participant Flow
Participant milestones
| Measure |
High-Impact Loading
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
Performed low-impact swimming exercise during intervention period.
|
Control Group
Didn't participate any organized physical exercises
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
High-Impact Loading
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
Performed low-impact swimming exercise during intervention period.
|
Control Group
Didn't participate any organized physical exercises
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises
Baseline characteristics by cohort
| Measure |
High-Impact Loading
n=11 Participants
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
n=11 Participants
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
n=11 Participants
Performed low-impact swimming exercise during intervention period.
|
Control Group
n=11 Participants
Didn't participate any organized physical exercises
|
Total
n=44 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
20.7 years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
21.1 years
STANDARD_DEVIATION 1.5 • n=7 Participants
|
22.8 years
STANDARD_DEVIATION 1.9 • n=5 Participants
|
22.6 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
21.8 years
STANDARD_DEVIATION 1.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Region of Enrollment
Turkey
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
11 participants
n=4 Participants
|
44 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
High-Impact Loading
n=11 Participants
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
n=11 Participants
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
n=11 Participants
Performed low-impact swimming exercise during intervention period.
|
Control Group
n=11 Participants
Didn't participate any organized physical exercises
|
|---|---|---|---|---|
|
Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises
|
-1.60 U/l
Standard Deviation 0.95
|
-0.53 U/l
Standard Deviation 0.44
|
-0.19 U/l
Standard Deviation 1.70
|
-0.12 U/l
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
High-Impact Loading
n=11 Participants
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
n=11 Participants
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
n=11 Participants
Performed low-impact swimming exercise during intervention period.
|
Control Group
n=11 Participants
Didn't participate any organized physical exercises
|
|---|---|---|---|---|
|
Physical (Body Mass Index) Changes of Participants
|
-0.73 kg/m^2
Standard Deviation 0.67
|
-0.49 kg/m^2
Standard Deviation 0.54
|
-0.72 kg/m^2
Standard Deviation 1.09
|
-0.07 kg/m^2
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksOutcome measures
| Measure |
High-Impact Loading
n=11 Participants
Performed high-impact running exercise during intervention period.
|
Moderate-Impact Loading
n=11 Participants
Performed moderate-impact cycling exercise during intervention period.
|
Non-Impact Loading
n=11 Participants
Performed low-impact swimming exercise during intervention period.
|
Control Group
n=11 Participants
Didn't participate any organized physical exercises
|
|---|---|---|---|---|
|
Physiological (Maximum Oxygen Consumption) Changes of Participants
|
4.91 ml/kg/min
Standard Deviation 3.48
|
2.93 ml/kg/min
Standard Deviation 2.20
|
5.46 ml/kg/min
Standard Deviation 2.51
|
1.11 ml/kg/min
Standard Deviation 3.32
|
Adverse Events
High-Impact Loading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate-Impact Loading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Impact Loading
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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