Trial Outcomes & Findings for Exercise Training Effects on Metabolic Syndrome: Interactions With Medication (NCT NCT03019796)
NCT ID: NCT03019796
Last Updated: 2021-06-14
Results Overview
Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
COMPLETED
EARLY_PHASE1
40 participants
Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.
2021-06-14
Participant Flow
All participants underwent four trials in a full cross-over randomized fashion. Subject tested before and after 4 months of training. At baseline subjects were tested on two occasions, one with and one without medication separated 72 hours. Post-training testing was similarly conducted with and without medication separated 72 hours.
Participant milestones
| Measure |
MEDICATED FIRST THEN PLACEBO
Subjects will remain taking their habitual antihypertensive medication during this time. After this first test, they will receive placebo during 72 h and will be tested again.
|
PLACEBO FIRST THEN MEDICATED
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo. Then their habitual medication will be restated and they will be tested again.
|
|---|---|---|
|
First Intervention Drug Tests
STARTED
|
20
|
20
|
|
First Intervention Drug Tests
COMPLETED
|
20
|
20
|
|
First Intervention Drug Tests
NOT COMPLETED
|
0
|
0
|
|
Second Intervention Training (4 Months)
STARTED
|
20
|
20
|
|
Second Intervention Training (4 Months)
COMPLETED
|
19
|
19
|
|
Second Intervention Training (4 Months)
NOT COMPLETED
|
1
|
1
|
|
Third Intervention Drug Test
STARTED
|
19
|
19
|
|
Third Intervention Drug Test
COMPLETED
|
19
|
19
|
|
Third Intervention Drug Test
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exercise Training Effects on Metabolic Syndrome: Interactions With Medication
Baseline characteristics by cohort
| Measure |
PRE-POST TRAINING
n=40 Participants
In this cross over design, participants will be tested PRE and POST 4 months of endurance training.
They will be tested while taking their habitual medication on one occasion and in the other, the investigators will withhold their medication during 72 h to achieve 4 conditions:
1. Untrained, no medicated.
2. Untrained, medicated.
a) Trained, no medicated. b) Trained, medicated.
|
|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 5.5 • n=93 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
40 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Population: All participants underwent four trials in a full cross-over randomized fashion
Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Systolic Blood Pressure
BEFORE TRAINING
|
126 mmHg
Standard Deviation 13
|
134 mmHg
Standard Deviation 11
|
|
Systolic Blood Pressure
AFTER TRAINING
|
124 mmHg
Standard Deviation 13
|
133 mmHg
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Diastolic Blood Pressure
BEFORE TRAINING
|
75 mmHg
Standard Deviation 8
|
79 mmHg
Standard Deviation 8
|
|
Diastolic Blood Pressure
AFTER TRAINING
|
72 mmHg
Standard Deviation 7
|
77 mmHg
Standard Deviation 7
|
PRIMARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Mean Arterial Pressure
BEFORE TRAINING
|
92 mmHg
Standard Deviation 9
|
97 mmHg
Standard Deviation 8
|
|
Mean Arterial Pressure
AFTER TRAINING
|
89 mmHg
Standard Deviation 8
|
96 mmHg
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Index of cardiorespiratory fitness assessed during an incremental cycle-ergometer test using an indirect calorimetry system. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Maximal Oxygen Consumption Rate During Exercise (VO2max).
BEFORE TRAINING
|
2.26 Liters of O2/kg weight/min
Standard Deviation 0.58
|
2.26 Liters of O2/kg weight/min
Standard Deviation 0.58
|
|
Maximal Oxygen Consumption Rate During Exercise (VO2max).
AFTER TRAINING
|
2.49 Liters of O2/kg weight/min
Standard Deviation 0.55
|
2.49 Liters of O2/kg weight/min
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Calculated in grams per min during the incremental cycloergometer test wih the use of indirect calorimetry system. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Maximal Rate of Fat Oxidation.
BEFORE TRAINING
|
0.24 grams/min
Standard Deviation 0.10
|
0.24 grams/min
Standard Deviation 0.10
|
|
Maximal Rate of Fat Oxidation.
AFTER TRAINING
|
0.28 grams/min
Standard Deviation 0.15
|
0.28 grams/min
Standard Deviation 0.15
|
SECONDARY outcome
Timeframe: Subject tested before and after 4 months of training. At baseline tested with and without medication separated 72 hours. Post training tested with and without medication separated 72 hours.Nude body weight. Value is the difference between the placebo and antihypertensive medication.
Outcome measures
| Measure |
MEDICATED
n=38 Participants
Subjects will take their habitual dose of antihypertensive medication.
|
PLACEBO
n=38 Participants
Subjects will be withdrawn from their habitual antihypertensive medication during 72 hours, which will be substituted by a placebo.
|
|---|---|---|
|
Body Weight
BEFORE TRAINING
|
92.1 kg
Standard Deviation 13.6
|
92.5 kg
Standard Deviation 13.6
|
|
Body Weight
AFTER TRAINING
|
90.0 kg
Standard Deviation 13.2
|
90.8 kg
Standard Deviation 13.4
|
Adverse Events
MEDICATED vs NO MEDICATED BEFORE TRAINING
MEDICATED vs NO MEDICATED AFTER EXERCISE TRAINING
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