Cardiorespiratory Fitness, Exercise Therapy, Metabolic Syndrome X
Conditions
Brief summary
To analyze the effects of different exercise training modalities (continuous, intervallic, and resistance training) on cardiorespiratory and metabolic fitness of metabolic syndrome patients when this training interacts with their habitual medication.
Detailed description
Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of different modalities of exercise training on cardiorespiratory and metabolic fitness. The main objective is to weight the effects of exercise training separately and in conjunction with the subject's habitual pharmacological treatment to identify the best combination of drug and exercise. Methods and design: Randomized, pretest-posttest control group experimental design. Project developed in a single center with the collaboration of the regional public health system. Subjects: Will be referred by their primary care physicians to our study unit. Up to 40 subjects all of them with metabolic syndrome will be recruited (at least 20% women). Measurements: 1. Specifically, the investigators, will study cardiovascular adaptations that increase, i) maximal aerobic capacity measured by VO2max, ii) anaerobic and respiratory compensation point ventilatory thresholds, iii) arterial stiffness, measured by pulse wave velocity (SphygmoCor System), v) central and peripheral blood pressure, and iv) biological markers of endothelial dysfunction using reactive hyperemia with a laser Doppler fluxmeter in central and peripheral blood vessels. 2. The metabolic adaptations under study will include, i) insulin sensitivity by HOMA-IR, ii) fat oxidation by indirect calorimetry
Interventions
DRUGMEDICATION AND EXERCISE TRAINING
PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD. THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE).
Sponsors
Ministerio de Economía y Competitividad, Spain
University of Castilla-La Mancha
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Metabolic syndrome patients diagnosed according to the International diabetes federation consensus of 2009 (Alberti, et al., Circulation). * 18-65 years old
Exclusion criteria
Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise. * Respiratory failure * Patient ends * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 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. |
| Diastolic Blood Pressure | 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. |
| Mean Arterial Pressure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Oxygen Consumption Rate During Exercise (VO2max). | 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. |
| Maximal Rate of Fat Oxidation. | 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. |
| Body Weight | 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. |
Countries
Spain
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PRE-POST TRAINING 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | PRE-POST TRAINING |
|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment Spain | 40 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Diastolic Blood Pressure
Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Diastolic Blood Pressure | BEFORE TRAINING | 75 mmHg | Standard Deviation 8 |
| MEDICATED | Diastolic Blood Pressure | AFTER TRAINING | 72 mmHg | Standard Deviation 7 |
| PLACEBO | Diastolic Blood Pressure | BEFORE TRAINING | 79 mmHg | Standard Deviation 8 |
| PLACEBO | Diastolic Blood Pressure | AFTER TRAINING | 77 mmHg | Standard Deviation 7 |
p-value: 0.054ANOVA
Primary
Mean Arterial Pressure
Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Mean Arterial Pressure | BEFORE TRAINING | 92 mmHg | Standard Deviation 9 |
| MEDICATED | Mean Arterial Pressure | AFTER TRAINING | 89 mmHg | Standard Deviation 8 |
| PLACEBO | Mean Arterial Pressure | BEFORE TRAINING | 97 mmHg | Standard Deviation 8 |
| PLACEBO | Mean Arterial Pressure | AFTER TRAINING | 96 mmHg | Standard Deviation 8 |
p-value: 0.04ANOVA
Primary
Systolic Blood Pressure
Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Systolic Blood Pressure | BEFORE TRAINING | 126 mmHg | Standard Deviation 13 |
| MEDICATED | Systolic Blood Pressure | AFTER TRAINING | 124 mmHg | Standard Deviation 13 |
| PLACEBO | Systolic Blood Pressure | BEFORE TRAINING | 134 mmHg | Standard Deviation 11 |
| PLACEBO | Systolic Blood Pressure | AFTER TRAINING | 133 mmHg | Standard Deviation 12 |
p-value: 0.04ANOVA
Secondary
Body Weight
Nude body weight. Value is the difference between the placebo and antihypertensive medication.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Body Weight | BEFORE TRAINING | 92.1 kg | Standard Deviation 13.6 |
| MEDICATED | Body Weight | AFTER TRAINING | 90.0 kg | Standard Deviation 13.2 |
| PLACEBO | Body Weight | BEFORE TRAINING | 92.5 kg | Standard Deviation 13.6 |
| PLACEBO | Body Weight | AFTER TRAINING | 90.8 kg | Standard Deviation 13.4 |
p-value: 0.021ANOVA
Secondary
Maximal Oxygen Consumption Rate During Exercise (VO2max).
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Maximal Oxygen Consumption Rate During Exercise (VO2max). | BEFORE TRAINING | 2.26 Liters of O2/kg weight/min | Standard Deviation 0.58 |
| MEDICATED | Maximal Oxygen Consumption Rate During Exercise (VO2max). | AFTER TRAINING | 2.49 Liters of O2/kg weight/min | Standard Deviation 0.55 |
| PLACEBO | Maximal Oxygen Consumption Rate During Exercise (VO2max). | BEFORE TRAINING | 2.26 Liters of O2/kg weight/min | Standard Deviation 0.58 |
| PLACEBO | Maximal Oxygen Consumption Rate During Exercise (VO2max). | AFTER TRAINING | 2.49 Liters of O2/kg weight/min | Standard Deviation 0.55 |
p-value: 0.321ANOVA
Secondary
Maximal Rate of Fat Oxidation.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MEDICATED | Maximal Rate of Fat Oxidation. | BEFORE TRAINING | 0.24 grams/min | Standard Deviation 0.1 |
| MEDICATED | Maximal Rate of Fat Oxidation. | AFTER TRAINING | 0.28 grams/min | Standard Deviation 0.15 |
| PLACEBO | Maximal Rate of Fat Oxidation. | BEFORE TRAINING | 0.24 grams/min | Standard Deviation 0.1 |
| PLACEBO | Maximal Rate of Fat Oxidation. | AFTER TRAINING | 0.28 grams/min | Standard Deviation 0.15 |
p-value: 0.401ANOVA