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| Name | Class |
|---|---|
| Ministerio de Economía y Competitividad, Spain | OTHER_GOV |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLACEBO FIRST THEN MEDICATED | Experimental | Subjects first receive the PLACEBO tablet during 72 hours (full withdrawal). After a week of taking again their medication (MEDICATION TRIAL), they will be tested again. This procedure will be repeated before and after 4 months of aerobic training. |
|
| MEDICATED FIRST THEN PLACEBO | Experimental | Subjects first receive their antihypertensive MEDICATION tablet (habitual dose prescribed by their primary care doctors). After a week they will take a PLACEBO tablet for 72 hours and will be tested again. This procedure will be repeated before and after 4 months of aerobic training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDICATION AND EXERCISE TRAINING | Drug | PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.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). |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | 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. |
| Diastolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | 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. |
| Mean Arterial Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Mora-Rodriguez, PhD | University of Castilla-La Mancha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Castilla-La Mancha (Exercise Physiology Lab) | Toledo | 45071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27787335 | Background | Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Pallares JG, Mora-Rodriguez R. Cardiovascular Drift during Training for Fitness in Patients with Metabolic Syndrome. Med Sci Sports Exerc. 2017 Mar;49(3):518-526. doi: 10.1249/MSS.0000000000001139. | |
| 27356240 | Background | Ortega JF, Morales-Palomo F, Fernandez-Elias V, Hamouti N, Bernardo FJ, Martin-Doimeadios RC, Nelson RK, Horowitz JF, Mora-Rodriguez R. Dietary supplementation with omega-3 fatty acids and oleate enhances exercise training effects in patients with metabolic syndrome. Obesity (Silver Spring). 2016 Aug;24(8):1704-11. doi: 10.1002/oby.21552. Epub 2016 Jun 29. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Drug Tests |
| |||||||||||||
| Second Intervention Training (4 Months) |
| |||||||||||||
| Third Intervention Drug Test |
|
The baseline trial is the non-medicated, no-exercise
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
a) Trained, no medicated. b) Trained, medicated. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years old rounding up without desmo points BASED ON DATE OF BIRTH |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | All participants underwent four trials in a full cross-over randomized fashion | Posted | Mean | Standard Deviation | mmHg | 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. |
|
4 months of the intervention
No adverse events were recorded
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MEDICATED vs NO MEDICATED BEFORE TRAINING | Subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h.
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Proffessor | University of Castilla-La Mancha | 925268800 | ricardo.mora@uclm.es |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2017 | Nov 8, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2017 | Nov 8, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2017 | Nov 8, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
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|
| 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. | 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. |
| Body Weight | Nude body weight. Value is the difference between the placebo and antihypertensive medication. | 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. |
| 26667921 | Background | Mora-Rodriguez R, Ortega JF, Guio de Prada V, Fernandez-Elias VE, Hamouti N, Morales-Palomo F, Martinez-Vizcaino V, Nelson RK. Effects of Simultaneous or Sequential Weight Loss Diet and Aerobic Interval Training on Metabolic Syndrome. Int J Sports Med. 2016 Apr;37(4):274-81. doi: 10.1055/s-0035-1564259. Epub 2015 Dec 14. |
| 25811624 | Background | Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher Insulin-sensitizing Response after Sprint Interval Compared to Continuous Exercise. Int J Sports Med. 2015 Mar;36(3):e4. doi: 10.1055/s-0035-1548800. Epub 2015 Mar 26. No abstract available. |
| 25491026 | Background | Martinez-Vizcaino V, Sanchez-Lopez M, Notario-Pacheco B, Salcedo-Aguilar F, Solera-Martinez M, Franquelo-Morales P, Lopez-Martinez S, Garcia-Prieto JC, Arias-Palencia N, Torrijos-Nino C, Mora-Rodriguez R, Rodriguez-Artalejo F. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial. Int J Behav Nutr Phys Act. 2014 Dec 10;11:154. doi: 10.1186/s12966-014-0154-4. |
| 25376729 | Background | Ortega JF, Fernandez-Elias VE, Hamouti N, Pallares JG, Mora-Rodriguez R. Higher insulin-sensitizing response after sprint interval compared to continuous exercise. Int J Sports Med. 2015 Mar;36(3):209-14. doi: 10.1055/s-0034-1389942. Epub 2014 Nov 6. |
| 24971679 | Background | Ortega JF, Hamouti N, Fernandez-Elias VE, Mora-Rodriguez R. Comparison of glucose tolerance tests to detect the insulin sensitizing effects of a bout of continuous exercise. Appl Physiol Nutr Metab. 2014 Jul;39(7):787-92. doi: 10.1139/apnm-2013-0507. Epub 2014 Apr 11. |
| 24682492 | Background | Ortega JF, Hamouti N, Fernandez-Elias VE, de Prada MV, Martinez-Vizcaino V, Mora-Rodriguez R. Metformin does not attenuate the acute insulin-sensitizing effect of a single bout of exercise in individuals with insulin resistance. Acta Diabetol. 2014 Oct;51(5):749-55. doi: 10.1007/s00592-014-0580-4. Epub 2014 Mar 29. |
| 24656853 | Background | Mora-Rodriguez R, Ortega JF, Hamouti N, Fernandez-Elias VE, Canete Garcia-Prieto J, Guadalupe-Grau A, Saborido A, Martin-Garcia M, Guio de Prada V, Ara I, Martinez-Vizcaino V. Time-course effects of aerobic interval training and detraining in patients with metabolic syndrome. Nutr Metab Cardiovasc Dis. 2014 Jul;24(7):792-8. doi: 10.1016/j.numecd.2014.01.011. Epub 2014 Jan 29. |
| 24198304 | Background | Diez-Fernandez A, Sanchez-Lopez M, Mora-Rodriguez R, Notario-Pacheco B, Torrijos-Nino C, Martinez-Vizcaino V. Obesity as a mediator of the influence of cardiorespiratory fitness on cardiometabolic risk: a mediation analysis. Diabetes Care. 2014;37(3):855-62. doi: 10.2337/dc13-0416. Epub 2013 Nov 6. |
| 37565392 | Derived | Alvarez-Jimenez L, Morales-Palomo F, Moreno-Cabanas A, Ortega JF, Mora-Gonzalez D, Mora-Rodriguez R. Acute Statin Withdrawal Does not Interfere With the Improvements of a Session of Exercise in Postprandial Metabolism. J Clin Endocrinol Metab. 2023 Dec 21;109(1):80-91. doi: 10.1210/clinem/dgad477. |
| 36171184 | Derived | Morales-Palomo F, Moreno-Cabanas A, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Effect of Yearly Exercise on Medication Expense and Benefit-Cost Ratio in Individuals with Metabolic Syndrome: A Randomized Clinical Trial. Med Sci Sports Exerc. 2023 Feb 1;55(2):158-166. doi: 10.1249/MSS.0000000000003053. Epub 2022 Sep 29. |
| 35578807 | Derived | Moreno-Cabanas A, Morales-Palomo F, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Effects of chronic metformin treatment on training adaptations in men and women with hyperglycemia: A prospective study. Obesity (Silver Spring). 2022 Jun;30(6):1219-1230. doi: 10.1002/oby.23410. Epub 2022 May 17. |
| 35438082 | Derived | Ramirez-Jimenez M, Morales-Palomo F, Moreno-Cabanas A, Alvarez-Jimenez L, Ortega JF, Mora-Rodriguez R. Aerobic exercise training improves nocturnal blood pressure dipping in medicated hypertensive individuals. Blood Press Monit. 2022 Aug 1;27(4):272-275. doi: 10.1097/MBP.0000000000000598. Epub 2022 Apr 18. |
| 35142713 | Derived | Moreno-Cabanas A, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Alvarez-Jimenez L, Mora-Rodriguez R. One Bout of Resistance Training Does Not Enhance Metformin Actions in Prediabetic and Diabetic Individuals. Med Sci Sports Exerc. 2022 Jul 1;54(7):1043-1050. doi: 10.1249/MSS.0000000000002889. Epub 2022 Feb 10. |
| 34560789 | Derived | Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A, Alvarez-Jimenez L. Endurance Exercise Training reduces Blood Pressure according to the Wilder's Principle. Int J Sports Med. 2022 Apr;43(4):336-343. doi: 10.1055/a-1548-6985. Epub 2021 Sep 24. |
| 33433153 | Derived | Morales-Palomo F, Moreno-Cabanas A, Ramirez-Jimenez M, Alvarez-Jimenez L, Valenzuela PL, Lucia A, Ortega JF, Mora-Rodriguez R. Exercise Reduces Medication for Metabolic Syndrome Management: A 5-Year Follow-up Study. Med Sci Sports Exerc. 2021 Jul 1;53(7):1319-1325. doi: 10.1249/MSS.0000000000002591. |
| 32598033 | Derived | Alvarez-Jimenez L, Moreno-Cabanas A, Ramirez-Jimenez M, Morales-Palomo F, Ortega JF, Mora-Rodriguez R. Effects of statins and exercise on postprandial lipoproteins in metabolic syndrome vs metabolically healthy individuals. Br J Clin Pharmacol. 2021 Mar;87(3):955-964. doi: 10.1111/bcp.14447. Epub 2020 Jul 12. |
| 31875915 | Derived | Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Moreno-Cabanas A, Mora-Rodriguez R. Exercise Training Adaptations in Metabolic Syndrome Individuals on Chronic Statin Treatment. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz304. doi: 10.1210/clinem/dgz304. |
| 31821339 | Derived | Guio de Prada V, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M, Moreno-Cabanas A, Mora-Rodriguez R. Women with metabolic syndrome show similar health benefits from high-intensity interval training than men. PLoS One. 2019 Dec 10;14(12):e0225893. doi: 10.1371/journal.pone.0225893. eCollection 2019. |
| 31415443 | Derived | Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Mora-Rodriguez R. Effectiveness of Aerobic Exercise Programs for Health Promotion in Metabolic Syndrome. Med Sci Sports Exerc. 2019 Sep;51(9):1876-1883. doi: 10.1249/MSS.0000000000001983. |
| 31158474 | Derived | Mora-Rodriguez R, Ortega JF, Ramirez-Jimenez M, Moreno-Cabanas A, Morales-Palomo F. Insulin sensitivity improvement with exercise training is mediated by body weight loss in subjects with metabolic syndrome. Diabetes Metab. 2020 Jun;46(3):210-218. doi: 10.1016/j.diabet.2019.05.004. Epub 2019 May 31. |
| 30459053 | Derived | Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M. Weight loss but not gains in cardiorespiratory fitness after exercise-training predicts improved health risk factors in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1267-1274. doi: 10.1016/j.numecd.2018.08.004. Epub 2018 Aug 23. |
| 29781921 | Derived | Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Mora-Rodriguez R. Exercise Periodization over the Year Improves Metabolic Syndrome and Medication Use. Med Sci Sports Exerc. 2018 Oct;50(10):1983-1991. doi: 10.1249/MSS.0000000000001659. |
| 29106772 | Derived | Mora-Rodriguez R, Ramirez-Jimenez M, Fernandez-Elias VE, Guio de Prada MV, Morales-Palomo F, Pallares JG, Nelson RK, Ortega JF. Effects of aerobic interval training on arterial stiffness and microvascular function in patients with metabolic syndrome. J Clin Hypertens (Greenwich). 2018 Jan;20(1):11-18. doi: 10.1111/jch.13130. Epub 2017 Nov 6. |
| 28803380 | Derived | Mora-Rodriguez R, Fernandez-Elias VE, Morales-Palomo F, Pallares JG, Ramirez-Jimenez M, Ortega JF. Aerobic interval training reduces vascular resistances during submaximal exercise in obese metabolic syndrome individuals. Eur J Appl Physiol. 2017 Oct;117(10):2065-2073. doi: 10.1007/s00421-017-3697-7. Epub 2017 Aug 12. |
| 28594711 | Derived | Morales-Palomo F, Ramirez-Jimenez M, Ortega JF, Lopez-Galindo PL, Fernandez-Martin J, Mora-Rodriguez R. Effects of repeated yearly exposure to exercise-training on blood pressure and metabolic syndrome evolution. J Hypertens. 2017 Oct;35(10):1992-1999. doi: 10.1097/HJH.0000000000001430. |
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| NOT COMPLETED |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Dichotomic male or female as declared by the own subject | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | No classification by ethnicity was attempted. In Spain there are more than 25 recognized ethnicities. The program lists Latino or Hispanic as the only choice. However, our subjects do not fit into that category. There are not the product of the mix of races since the discovery and colonization of America starting in 1492 by Spaniards, Portugueses, and Italians. On the contrary, they are the ones that stayed in Europe. The simile will be to stablish that people in US should be named Anglosaxonis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | In south Europe we have caucasians, asians, blacks, and gypsies as main races. Again, the program does not allow these choices. | Count of Participants | Participants |
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| Region of Enrollment | The basic region were we are recruiting subjects is south Europe (Spain). | Number | participants |
|
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| Primary | Diastolic Blood Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | Posted | Mean | Standard Deviation | mmHg | 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. |
|
|
|
|
| Primary | Mean Arterial Pressure | Determined using a ECG-gated automated sphygmomanometer. Value is the difference between the placebo and antihypertensive medication. | Posted | Mean | Standard Deviation | mmHg | 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. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | Liters of O2/kg weight/min | 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. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | grams/min | 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. |
|
|
|
|
| Secondary | Body Weight | Nude body weight. Value is the difference between the placebo and antihypertensive medication. | Posted | Mean | Standard Deviation | kg | 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. |
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|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | MEDICATED vs NO MEDICATED AFTER EXERCISE TRAINING | After 4 months of endurance training subjects will be tested twice one taking their habitual dose of medication, and in the other, the investigators will withhold their medication during 72 h. c) Trained, no medicated. d) Trained, medicated. | 0 | 40 | 0 | 40 | 0 | 40 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |