Trial Outcomes & Findings for Impact of Statin Therapy on Adaptations to Aerobic Exercise (NCT NCT03360916)
NCT ID: NCT03360916
Last Updated: 2025-04-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
Value at 3 months minus value at baseline
Results posted on
2025-04-15
Participant Flow
All 52 participants that were officially enrolled were randomized
Participant milestones
| Measure |
Placebo
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
Participants will receive Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
Participants will receive Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
17
|
19
|
|
Overall Study
COMPLETED
|
14
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Statin Therapy on Adaptations to Aerobic Exercise
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=17 Participants
Participants receiving Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=19 Participants
Participants receiving Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.13 years
STANDARD_DEVIATION 8.29 • n=99 Participants
|
51.28 years
STANDARD_DEVIATION 9.04 • n=107 Participants
|
50.85 years
STANDARD_DEVIATION 7.96 • n=206 Participants
|
50.78 years
STANDARD_DEVIATION 8.28 • n=157 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
40 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
37 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=99 Participants
|
17 participants
n=107 Participants
|
19 participants
n=206 Participants
|
52 participants
n=157 Participants
|
|
Total Cholesterol
|
200.19 mg/dL
STANDARD_DEVIATION 31.63 • n=99 Participants
|
220.33 mg/dL
STANDARD_DEVIATION 38.54 • n=107 Participants
|
204.90 mg/dL
STANDARD_DEVIATION 32.24 • n=206 Participants
|
208.65 mg/dL
STANDARD_DEVIATION 34.72 • n=157 Participants
|
|
Weight
|
94.74 kg
STANDARD_DEVIATION 16.15 • n=99 Participants
|
103.42 kg
STANDARD_DEVIATION 20.06 • n=107 Participants
|
95.83 kg
STANDARD_DEVIATION 14.33 • n=206 Participants
|
98.10 kg
STANDARD_DEVIATION 17.08 • n=157 Participants
|
|
BMI
|
34.68 kg/m^2
STANDARD_DEVIATION 4.58 • n=99 Participants
|
35.43 kg/m^2
STANDARD_DEVIATION 5.14 • n=107 Participants
|
34.55 kg/m^2
STANDARD_DEVIATION 4.84 • n=206 Participants
|
34.88 kg/m^2
STANDARD_DEVIATION 4.79 • n=157 Participants
|
|
Relative Peak VO2 Max
|
25.29 mL/kg/min
STANDARD_DEVIATION 6.21 • n=99 Participants
|
21.30 mL/kg/min
STANDARD_DEVIATION 6.27 • n=107 Participants
|
22.74 mL/kg/min
STANDARD_DEVIATION 5.74 • n=206 Participants
|
22.97 mL/kg/min
STANDARD_DEVIATION 6.15 • n=157 Participants
|
PRIMARY outcome
Timeframe: Value at 3 months minus value at baselineOutcome measures
| Measure |
Placebo
n=11 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=10 Participants
Participants receiving Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=14 Participants
Participants receiving Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Difference in Mitochondrial Respiratory Function
|
2.29 pmols/s/mg
Standard Deviation 125.59
|
-11.24 pmols/s/mg
Standard Deviation 130.12
|
44.88 pmols/s/mg
Standard Deviation 105.19
|
SECONDARY outcome
Timeframe: Value at 12 months minus value at baselineOutcome measures
| Measure |
Placebo
n=14 Participants
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=13 Participants
Participants receiving Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=16 Participants
Participants receiving Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Change in VO2 Max
|
0.22 L/min
Standard Deviation 0.18
|
0.23 L/min
Standard Deviation 0.21
|
0.21 L/min
Standard Deviation 0.23
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Low Dose Statin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
High Dose Statin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
Participants receiving matching placebo oral tablet.
Placebo Oral Tablet: Matching placebo pill.
|
Low Dose Statin
n=17 participants at risk
Participants receiving Lipitor 20Mg Tablet to take daily.
Lipitor 20Mg Tablet: 20 mg/day pills.
|
High Dose Statin
n=19 participants at risk
Participants receiving Lipitor 80Mg Tablet to take daily.
Lipitor 80Mg Tablet: 80 mg/day pills.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle or Joint Pain
|
12.5%
2/16 • Number of events 2 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
23.5%
4/17 • Number of events 4 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
36.8%
7/19 • Number of events 7 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
|
Musculoskeletal and connective tissue disorders
Restless Legs
|
6.2%
1/16 • Number of events 1 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
5.9%
1/17 • Number of events 1 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
0.00%
0/19 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Illness
|
0.00%
0/16 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
0.00%
0/17 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
10.5%
2/19 • Number of events 2 • Participants were contacted weekly by phone or email and prompted to disclose any adverse events. Additional adverse events could be reported if participant contacted study team outside of the usual weekly check in. Adverse events were monitored until symptoms subsided or adverse event ended or until the end of the 12 month intervention period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place