Metabolic SyndromePhase 2NCT02918448
Resistance Training and Metabolic Syndrome
A Phase 2 study testing Training group in people with Metabolic Syndrome, run by Universidade Estadual de Londrina.
Trial summary
Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory… Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation.
- Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation.
Who cannot join
- All subjects not participating in 85% of the total sessions of training or withdrawl
About this study
Official title: A Resistance Training Program Decreases the Risk of Metabolic Syndrome and Inflammatory Biomarkers in Older Adult Women: A Randomized Controlled Trial
Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory biomarkers in older adult women
Read the detailed description
The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory biomarkers in older adult women. For the selection of the sample all participants completed a health history and we adopted the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation. Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation. Written informed consent was obtained from all participants after being provided with a detailed description of investigation procedures. This investigation was conducted according to the Declaration of Helsinki and approved by the local University Ethics Committee. The investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. It was also evaluated the Z-score risk for metabolic syndrome, which was based on the risk factors for metabolic syndrome. A supervised progressive RT program was performed between weeks 4-15 by the training group. The CG did not perform any type of physical exercise during this period. The RT training program was based on recommendations for RT in an older population. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. Participants of the TG performed 3 sets of 10-15 repetition maximums. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise. Instructors adjusted the loads of each exercise according to the subject's ability and improvements in exercise capacity throughout the investigation in order to ensure that the subjects were exercising with as much resistance as possible while maintaining proper exercise technique.
- Conditions
- Metabolic Syndrome
- Being tested
- Training group
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training groupOther
The investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. A supervised progressive RT program was performed between weeks 4-15 by the training group.
| Study group | Role | What they receive |
|---|---|---|
| Taining group | Experimental | training group that performed the resistance program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. Participants of the TG performed 3 sets of 10-15 repetition maximums. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise Receives: Other: Training group |
| control group | No intervention | control group that did not perform any type of physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Biomarkes
Measurements of TNF-α, and IL-6, were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R\&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). The results are presented in picograms per milliliter (pg/ml). All samples were determined in duplicate to guarantee the precision of the results.
Measured: Baseline and 12 weeks
Change in Lipid and Glycemic Profiles
Venous blood samples were collected after a 12 h fast and a minimum of 72 h after the final physical exercise session. Five milliliters were withdrawn from a prominent superficial vein in the antecubital space using a clean venous puncture with minimal stasis and placed in a tube containing ethylenediaminetetraacetic acid (EDTA) as an anticoagulant and conservant and a tube without coagulant. All samples were centrifuged for 15 min, and plasma or serum aliquots were stored at -80ºC until assayed. Measurements of glucose, high-density lipoprotein (HDL-C), and triglycerides (TG), were immediately determined in a specialized laboratory at University Hospital. The analyses were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature, consistent with the manufacturer's recommendations. The results are presented in milligrams per deciliter (mg/dL)
Measured: Baseline and 12 weeks
Change in Homeostasis Model Assessment (HOMA-IR)
Insulin was measured by chemiluminescence using a Liaison XL analyzer (DiaSorin S.p.A., Saluggia, Italy). The homeostasis model assessment (HOMA-IR) was calculated by the formula: fasting insulin (μUI/ml) x fasting glucose (mmol/L)/22.5. Inter- and intra-assay coefficients of variation were <10% as determined in human plasma.
Measured: Baseline and 12 weeks
Change in Blood Pressure
Resting BP assessment was performed using automatic oscillometric equipment (Omron HEM-742INT model, Omron Corporation, Kyoto, Kansai, Japan). Participants attended the laboratory on three different days and, during each visit, remained seated at rest for five minutes with the cuff of the equipment in place on the right arm. Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in Systolic BP (SBP) and Diastolic BP (DBP) readings differed by no more than 4 mmHg. The median of the three measurements for each day was averaged across the three visits. Mean arterial pressure (MAP) was calculated using the formula MAP= DBP + 1/3 (SBP-DBP). The results are presented in (mmHg)
Measured: Baseline and 12 weeks
Change in Metabolic Syndrome Z score
The metabolic syndrome Z score was also used in the present investigation as a continuous score of the five metabolic syndrome variables in agreement with the Adult Treatment Panel III criteria. A Z score was calculated for each variable using individual data, and standard deviations of data for the entire group at baseline (n = 53) and post intervention (n =47). The equation used to calculate the metabolic syndrome Z-score was Z score pre intervention = [(50 - HDL)/11.1 (11.9m2) + (TG - 150)/36.8 (42.1)] + [(fasting blood glucose - 100)/14.8 (13.7 m2)] + [(waist circumference - 88)/9.4 (9.9 m2)] + [(mean arterial pressure - 100)/6.4 (7.7) m2], and Z score post intervention= [(50 - HDL)/11.9 + (TG - 150)/42.1)] + [(fasting blood glucose - 100)/13.7)] + [(waist circumference - 88)/9.9] + [(mean arterial pressure - 100)/7.7)].
Measured: Baseline and 12 weeks
Change in C-reative Protein
Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligram/liter (mg/L)
Measured: Baseline and 12 weeks
Change in Body Composition
Whole-body dual-energy X-ray absorptiometry (DXA) scans (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) were used to assess body fat, trunk fat and appendicular lean soft tissue. The total skeletal muscle mass was estimated by the predictive equation proposed by Kim et al.. Prior to scanning, participants were instructed to remove all objects containing metal. Scans were performed with the subjects lying in the supine position along the table's longitudinal centerline axis. Feet were taped together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. Both calibration and analysis were carried out by a skilled laboratory technician. Equipment calibration followed the manufacturer's recommendations. The software generated standard lines that set apart the limbs from the trunk and head. These lines were adjusted by the same technician using specific anatomical points determined by the manufacturer.
Measured: Baseline and 12 weeks
Change in Waist Circumference
Measures of waist circumference (WC) were obtained according to procedures established in the literature. The results are presented in centimeters (cm).
Measured: Baseline and 12 weeks
Secondary outcomes (3)
Changes in Anthropometry Parameters
Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale (Balmak, Laboratory Equipment Labstore, Curitiba, Paraná, Brazil), with the participants wearing light workout clothing and no shoes. Height was measured with a stadiometer attached to the scale to the nearest 0.1 cm, with subjects standing without shoes. Body mass index was calculated as body mass in kilograms divided by the square of height in meters.
Measured: Baseline and 12 weeks
Changes in Total Strength
Maximal dynamic strength was evaluated using the 1RM test assessed in the chest press (CP), knee extension (KE), and preacher curl (PC) exercises, performed in this exact order. Testing for each exercise was preceded by a warm-up set (6-10 repetitions), with approximately 50% of the estimated load used in the first attempt of the 1RM. This warm-up was also used to familiarize the subjects with the testing equipment and lifting technique. The testing procedure was initiated 2 minutes after the warm-up. The subjects were instructed to try to accomplish two repetitions with the imposed load and were given three attempts in both exercises. The rest period was 3 to 5 min between each attempt, and 5 min between exercises. The 1RM was recorded as the final load lifted in which the subject was able to complete only one single maximal execution. Total strength was determined by the sum of the 3 exercises.
Measured: Baseline and 12 weeks
Changes in Dietary intake
Participants were instructed by a dietitian to complete a food record on three nonconsecutive days (two week days and one weekend day) pre- and post-intervention. Participants were given specific instructions regarding the recording of portion sizes and quantities to identify all food and fluid intake, in addition to viewing food models in order to enhance precision. Total energy intake, protein, carbohydrate, and lipid content were calculated using nutrition analysis software (Avanutri Processor Nutrition Software, Rio de Janeiro, Brazil; Version 3.1.4).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crisieli Maria Tomeleri, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918448
- Sponsor's protocol ID
- UEL10656/2012
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
PubMed 21694556Conceicao MS, Bonganha V, Vechin FC, Berton RP, Lixandrao ME, Nogueira FR, de Souza GV, Chacon-Mikahil MP, Libardi CA. Sixteen weeks of resistance training can decrease the risk of metabolic syndrome in healthy postmenopausal women. Clin Interv Aging. 2013;8:1221-8. doi: 10.2147/CIA.S44245. Epub 2013 Sep 16.
PubMed 24072967Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
PubMed 16157765Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D. Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr. 2002 Aug;76(2):378-83. doi: 10.1093/ajcn/76.2.378.
PubMed 12145010
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Resistance Training Program Decreases the Risk of Metabolic Syndrome and Inflammatory Biomarkers in Older Adult Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02918448
- Acronym / sponsor ID
- UEL10656/2012
- Conditions
- Metabolic Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic syndrome (MetS) is a multicomponent disorder closely linked to low grade inflammation, and cardiovascular disease (CVD). The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory biomarkers in older adult women
Detailed description
The aim of this study was to investigate the effects of a 12-week resistance training (RT) program on body composition, risk factors for metabolic syndrome (MetS), and inflammatory biomarkers in older adult women. For the selection of the sample all participants completed a health history and we adopted the following inclusion criteria: 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation. Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation. Written informed consent was obtained from all participants after being provided with a detailed description of investigation procedures. This investigation was conducted according to the Declaration of Helsinki and approved by the local University Ethics Committee. The investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. It was also evaluated the Z-score risk for metabolic syndrome, which was based on the risk factors for metabolic syndrome. A supervised progressive RT program was performed between weeks 4-15 by the training group. The CG did not perform any type of physical exercise during this period. The RT training program was based on recommendations for RT in an older population. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. Participants of the TG performed 3 sets of 10-15 repetition maximums. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise. Instructors adjusted the loads of each exercise according to the subject's ability and improvements in exercise capacity throughout the investigation in order to ensure that the subjects were exercising with as much resistance as possible while maintaining proper exercise technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taining group | Experimental | Other: Training grouptraining group that performed the resistance program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. Participants of the TG performed 3 sets of 10-15 repetition maximums. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise |
| control group | No intervention | –control group that did not perform any type of physical exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 60 years old or more, physically independent, free from cardiac or orthopedic dysfunction, not receiving hormonal replacement therapy, and not performing any regular physical exercise more than once a week in the six months preceding the beginning of the investigation.
- Participants passed a diagnostic graded exercise stress test with a 12-lead electrocardiogram, reviewed by a cardiologist, and were released with no restrictions for participation in this investigation.
Key exclusion criteria (1 listed)
- All subjects not participating in 85% of the total sessions of training or withdrawl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training groupThe investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. A supervised progressive RT program was performed between weeks 4-15 by the training group. | Other | Taining group |
Primary outcome
Change in Inflammatory Biomarkes
Time frame: Baseline and 12 weeks
Measurements of TNF-α, and IL-6, were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R\&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). The results are presented in picograms per milliliter (pg/ml). All samples were determined in duplicate to guarantee the precision of the results.
Change in Lipid and Glycemic Profiles
Time frame: Baseline and 12 weeks
Venous blood samples were collected after a 12 h fast and a minimum of 72 h after the final physical exercise session. Five milliliters were withdrawn from a prominent superficial vein in the antecubital space using a clean venous puncture with minimal stasis and placed in a tube containing ethylenediaminetetraacetic acid (EDTA) as an anticoagulant and conservant and a tube without coagulant. All samples were centrifuged for 15 min, and plasma or serum aliquots were stored at -80ºC until assayed. Measurements of glucose, high-density lipoprotein (HDL-C), and triglycerides (TG), were immediately determined in a specialized laboratory at University Hospital. The analyses were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature, consistent with the manufacturer's recommendations. The results are presented in milligrams per deciliter (mg/dL)
Change in Homeostasis Model Assessment (HOMA-IR)
Time frame: Baseline and 12 weeks
Insulin was measured by chemiluminescence using a Liaison XL analyzer (DiaSorin S.p.A., Saluggia, Italy). The homeostasis model assessment (HOMA-IR) was calculated by the formula: fasting insulin (μUI/ml) x fasting glucose (mmol/L)/22.5. Inter- and intra-assay coefficients of variation were <10% as determined in human plasma.
Change in Blood Pressure
Time frame: Baseline and 12 weeks
Resting BP assessment was performed using automatic oscillometric equipment (Omron HEM-742INT model, Omron Corporation, Kyoto, Kansai, Japan). Participants attended the laboratory on three different days and, during each visit, remained seated at rest for five minutes with the cuff of the equipment in place on the right arm. Subsequently, several BP measurements were performed at one-minute intervals in order to obtain three consecutive measurements where the difference in Systolic BP (SBP) and Diastolic BP (DBP) readings differed by no more than 4 mmHg. The median of the three measurements for each day was averaged across the three visits. Mean arterial pressure (MAP) was calculated using the formula MAP= DBP + 1/3 (SBP-DBP). The results are presented in (mmHg)
Change in Metabolic Syndrome Z score
Time frame: Baseline and 12 weeks
The metabolic syndrome Z score was also used in the present investigation as a continuous score of the five metabolic syndrome variables in agreement with the Adult Treatment Panel III criteria. A Z score was calculated for each variable using individual data, and standard deviations of data for the entire group at baseline (n = 53) and post intervention (n =47). The equation used to calculate the metabolic syndrome Z-score was Z score pre intervention = [(50 - HDL)/11.1 (11.9m2) + (TG - 150)/36.8 (42.1)] + [(fasting blood glucose - 100)/14.8 (13.7 m2)] + [(waist circumference - 88)/9.4 (9.9 m2)] + [(mean arterial pressure - 100)/6.4 (7.7) m2], and Z score post intervention= [(50 - HDL)/11.9 + (TG - 150)/42.1)] + [(fasting blood glucose - 100)/13.7)] + [(waist circumference - 88)/9.9] + [(mean arterial pressure - 100)/7.7)].
Change in C-reative Protein
Time frame: Baseline and 12 weeks
Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligram/liter (mg/L)
Change in Body Composition
Time frame: Baseline and 12 weeks
Whole-body dual-energy X-ray absorptiometry (DXA) scans (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) were used to assess body fat, trunk fat and appendicular lean soft tissue. The total skeletal muscle mass was estimated by the predictive equation proposed by Kim et al.. Prior to scanning, participants were instructed to remove all objects containing metal. Scans were performed with the subjects lying in the supine position along the table's longitudinal centerline axis. Feet were taped together at the toes to immobilize the legs while the hands were maintained in a pronated position within the scanning region. Both calibration and analysis were carried out by a skilled laboratory technician. Equipment calibration followed the manufacturer's recommendations. The software generated standard lines that set apart the limbs from the trunk and head. These lines were adjusted by the same technician using specific anatomical points determined by the manufacturer.
Change in Waist Circumference
Time frame: Baseline and 12 weeks
Measures of waist circumference (WC) were obtained according to procedures established in the literature. The results are presented in centimeters (cm).
3 secondary outcomes
Changes in Anthropometry Parameters
Time frame: Baseline and 12 weeks
Changes in Total Strength
Time frame: Baseline and 12 weeks
Changes in Dietary intake
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
- Results publication: PubMed 21694556Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb.
- Results publication: PubMed 24072967Conceicao MS, Bonganha V, Vechin FC, Berton RP, Lixandrao ME, Nogueira FR, de Souza GV, Chacon-Mikahil MP, Libardi CA. Sixteen weeks of resistance training can decrease the risk of metabolic syndrome in healthy postmenopausal women. Clin Interv Aging. 2013;8:1221-8. doi: 10.2147/CIA.S44245. Epub 2013 Sep 16.
- Results publication: PubMed 16157765Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Costa F; American Heart Association; National Heart, Lung, and Blood Institute. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute Scientific Statement. Circulation. 2005 Oct 25;112(17):2735-52. doi: 10.1161/CIRCULATIONAHA.105.169404. Epub 2005 Sep 12. No abstract available.
- Results publication: PubMed 12145010Kim J, Wang Z, Heymsfield SB, Baumgartner RN, Gallagher D. Total-body skeletal muscle mass: estimation by a new dual-energy X-ray absorptiometry method. Am J Clin Nutr. 2002 Aug;76(2):378-83. doi: 10.1093/ajcn/76.2.378.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Training group in people with Metabolic Syndrome, run by Universidade Estadual de Londrina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Biomarkes (time frame: Baseline and 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02918448, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2016.