Metabolic Syndrome XBELLUGATNCT02832453
Metabolic Risk Management, Physical Exercise and Lifestyle Counselling in Low-active Adults; Controlled Randomized Trial
A study testing Lifestyle, Aerobic interval training and Traditional continous training in people with Metabolic Syndrome X and Lifestyle-related Condition, run by INEFC-Lleida at 1 site in Spain.
Trial summary
The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors. Read more about this study
- Who is it for?
- Ages 30 to 52 years
- Conditions the study is for
- Metabolic Syndrome X, Lifestyle-related Condition, Lifestyle Risk Reduction
- What is being tested?
- Lifestyle, Aerobic interval training and Traditional continous training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2016to 31 Dec 2017
- Phase
- Interventional
- 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 30 to 52 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Low active (achieving less than 150 minutes/week of moderate-to-vigorous physical activity or have not participated in any supervised exercise programs for at least the last 6 months).
- Having one or more risk factors for metabolic syndrome (Marcuello et al., 2013) (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; high density lipoprotein cholesterol in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
- Accept and sign the written informed consent.
- Accept the randomized group assignment.
Who cannot join
- Couples or individuals living in the same house
- Morbid obesity (BMI ≥ 40).
- A past/current history and/or physical examination or laboratory findings of significant diseases of cardiovascular, respiratory, neuromuscular, psychiatric diseases/disorders.
- Diseases/disorders that may contraindicate performing physical exercise or a stress test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supervised Physical Exercise and Lifestyle Counselling in the Management of Metabolic Risk in Low-active Adults; a Controlled Randomized Trial. Belluga't de CAP a Peus
The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and sedentary habits, and the cost-effectiveness of the intervention with regard to health related quality of life.
Read more
The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk, physical condition, physical activity/sedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration.
Read the detailed description
The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and sedentary habits, and the cost-effectiveness of the intervention with regard to health related quality of life.
The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk, physical condition, physical activity/sedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration.
Adults aged 30 to 52 years with metabolic risk factors will be randomized in three intervention groups that will be given one of the following: assessment on healthy lifestyle plus high intensity physical exercise supervision (3 individual and 6 group sessions + 16 supervised training lessons); assessment plus low-to-moderate intensity physical exercise supervision (3 individual and 6 group sessions + 16 supervised training lessons) or assessment-based programme without physical exercise supervision (3 individual and 6 group sessions).
The main output variables evaluated will be: a) risk factors for the metabolic syndrome (waist circumference, blood pressure, and plasma triglycerides, high density lipoproteins and glucose), systemic inflammation and adipose tissue functionality, physical activity habits and sedentary conducts, dietary habits, quality of life related to health, self-efficacy and empowerment. The economic cost will also be analysed to determine the cost-effectiveness of the program. These variables will be assessed 3 times alongside the study: at baseline, at the end of the 4 months intervention, and at 6 months follow-up. It has been estimated to recruit 33 participants per group, which are 100 participants.
- Conditions
- Metabolic Syndrome X, Lifestyle-related Condition, Lifestyle Risk Reduction, Cardiovascular Risk Factor
- Being tested
- Lifestyle, Aerobic interval training, Traditional continous training
- Keywords
- High intensity physical exercise, Primary health care, Behaviour change interventions
- Medical subject headings
- Metabolic Syndrome, Mental Disorders, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifestyleBehavioural
The counselling program consists of 6 group meetings of 1 hour and 3 individual consultations of at least 15 minutes each. Sessions will be set up with the aim to enhance knowledge and empowerment related to physical activity, sedentary conducts, dietary habits, as well as strategies for behaviour change will be given. Individual consultations will focus on establishing realistic objectives and to involve the participants in taking decisions.
Aerobic interval trainingBehavioural
The supervised aerobic interval training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of 4 series of 4 minutes of cycling at a heart rate of 80% of the VO2peak interspersed with active pauses of 2 minutes at 60% of the VO2peak .
Traditional continous trainingBehavioural
The supervised traditional continous training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of activities such as walking, cycling, or tonification exercises always at an intensity of 60% of the VO2peak.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Other | This group will receive lifestyle counselling but not supervised exercise training sessions Receives: Behavioral: Lifestyle |
| Aerobic interval training | Experimental | This group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions Receives: Behavioral: Lifestyle; Behavioral: Aerobic interval training |
| Traditional continous training | Active comparator | This group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions Receives: Behavioral: Lifestyle; Behavioral: Traditional continous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in metabolic risc score
A continuous metabolic syndrome risk score (cMSSy) will be calculated as described by Wijndaele (Wijndaele et al., 2006). The score contains the five risk factors considered in the definition of the metabolic syndrome (Expert panel on detection, 2001; Marcuello et al., 2013), that is waist circumference, triglycerides, high density lipoproteins cholesterol, systolic blood pressure and plasma glucose.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Secondary outcomes (11)
Change from baseline in cardiorespiratory fitness
Improvement of peak oxygen uptake (VO2peak). Cardiorespiratory fitness will be assessed by means of voluntary maximal graded exercise on a cycle ergometer while measuring oxygen consumption (VO2).
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in active lifestyle
Daily time spent at moderate-to-vigorous physical activity. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for moderate-to-vigorous physical activity will be set above 2020 counts per minute.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in sedentary time
Reduction of the daily time devoted to sedentary conducts. Participants will wear Actigraph accelerometers (GT3X+ models) during all day for seven consecutive days. Cut points for sedentary conducts will be set under 100 counts per minute.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in dietary habits
Improvement of healthy eating index
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in physical activity self-efficacy questionnaire
Spanish version of the physical activity scale (Fernández-Cabrera, Medina, Rueda, Ordoñez, \& León, 2012)
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in empowerment
Health Empowerment Scale (HES) (Serrani, 2014)
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life at the end of the intervention
Quality of life questionaire (EQ-5D)
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life
Quality of life questionaire (EQ-5D)
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in interleucin-6
Fasting blood samples will be drawn to determine interleukin by cytometry.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in adiponectin
Fasting blood samples will be drawn to determine adiponectin by cytometry.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in plasma metabolome
Fasting blood samples will be drawn to determine plasma metabolome.
Measured: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- INEFC-Lleida
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, Universitat de Lleida, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Responsible party
- Principal investigator, Assumpta Ensenyat, INEFC-Lleida
- Investigators
- Assumpta Ensenyat, MD, PhD, Principal investigator, INEFC-Lleida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832453
- Sponsor's protocol ID
- 2014-PINEFC00003
- Acronym
- BELLUGAT
- Status last verified
- Aug 2019
- First submitted
- 6 Jul 2016
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: At present we have not planned to share data. Probably at the end of the trail we will put them on the repository of the University of Lleida.
Publications
Ensenyat A, Espigares-Tribo G, Machado-Da-Silva L, Sinfreu-Bergues X, Blanco A. Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT). J Phys Act Health. 2020 Jun 12;17(7):744-755. doi: 10.1123/jpah.2019-0409.
PubMed 32531762Ensenyat A, Espigares-Tribo G, Machado L, Verdejo FJ, Rodriguez-Arregui R, Serrano J, Miret M, Galindo G, Blanco A, Marsal JR, Sarriegui S, Sinfreu-Bergues X, Serra-Paya N. Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT). BMC Public Health. 2017 Mar 14;17(1):257. doi: 10.1186/s12889-017-4144-8.
PubMed 28292282
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supervised Physical Exercise and Lifestyle Counselling in the Management of Metabolic Risk in Low-active Adults; a Controlled Randomized Trial. Belluga't de CAP a Peus
- ClinicalTrials.gov ID
- NCT02832453
- Acronym / sponsor ID
- BELLUGAT / 2014-PINEFC00003
- Conditions
- Metabolic Syndrome X, Lifestyle-related Condition, Lifestyle Risk Reduction, Cardiovascular Risk Factor
- Keywords
- High intensity physical exercise, Primary health care, Behaviour change interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- INEFC-LleidaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, Universitat de Lleida, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Study start
- Feb 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Jul 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.
The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and sedentary habits, and the cost-effectiveness of the intervention with regard to health related quality of life.
The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk, physical condition, physical activity/sedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration.
Detailed description
The purpose of this study is evaluate the effectiveness of different doses of supervised exercise training intensity -concomitant to lifestyle counselling- as a Primary Health Care intervention tool for the management of the metabolic syndrome in low active adults with one or more metabolic risk factors.
Secondary aims of the study are to investigate the effects of these interventions on systemic inflammation and adipose tissue function, cardiorespiratory fitness, physical activity and sedentary habits, and the cost-effectiveness of the intervention with regard to health related quality of life.
The general hypothesis is that adults with risk factors for metabolic syndrome participating in interventions for the promotion of a healthy lifestyle that together with counselling strategies will include supervised physical exercise of vigorous intensity will present greater improvements in terms of metabolic risk, physical condition, physical activity/sedentary behaviours and psychological parameters at the end of the intervention and at 6-months follow-up than participants in interventions for the promotion of a healthy lifestyle that will include counselling plus physical exercise of low-to-moderate intensity or interventions based exclusively on counselling.
It is a three arms controlled randomized clinical trial implemented in the Primary Health Care setting and of 10 months duration.
Adults aged 30 to 52 years with metabolic risk factors will be randomized in three intervention groups that will be given one of the following: assessment on healthy lifestyle plus high intensity physical exercise supervision (3 individual and 6 group sessions + 16 supervised training lessons); assessment plus low-to-moderate intensity physical exercise supervision (3 individual and 6 group sessions + 16 supervised training lessons) or assessment-based programme without physical exercise supervision (3 individual and 6 group sessions).
The main output variables evaluated will be: a) risk factors for the metabolic syndrome (waist circumference, blood pressure, and plasma triglycerides, high density lipoproteins and glucose), systemic inflammation and adipose tissue functionality, physical activity habits and sedentary conducts, dietary habits, quality of life related to health, self-efficacy and empowerment. The economic cost will also be analysed to determine the cost-effectiveness of the program. These variables will be assessed 3 times alongside the study: at baseline, at the end of the 4 months intervention, and at 6 months follow-up. It has been estimated to recruit 33 participants per group, which are 100 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Other | Behavioral: LifestyleThis group will receive lifestyle counselling but not supervised exercise training sessions |
| Aerobic interval training | Experimental | Behavioral: Lifestyle, Behavioral: Aerobic interval trainingThis group will receive lifestyle counselling plus supervised high intensity (80%VO2max) interval exercise training sessions |
| Traditional continous training | Active comparator | Behavioral: Lifestyle, Behavioral: Traditional continous trainingThis group will receive lifestyle counselling plus supervised moderate intensity (60%VO2max) continous exercise training sessions |
Who may qualify
- Ages
- 30 to 52 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Low active (achieving less than 150 minutes/week of moderate-to-vigorous physical activity or have not participated in any supervised exercise programs for at least the last 6 months).
- Having one or more risk factors for metabolic syndrome (Marcuello et al., 2013) (waist circumference >94.5 cm for men and >89.5 cm for women; blood pressure ≥130/85 mmHg; triglycerides in plasma ≥150 mg/dL; high density lipoprotein cholesterol in plasma <40 mg/dL for men and <50 mg/dL for women; fasting glycaemia ≥100 mg/dL).
- Accept and sign the written informed consent.
- Accept the randomized group assignment.
Key exclusion criteria (4 listed)
- Couples or individuals living in the same house
- Morbid obesity (BMI ≥ 40).
- A past/current history and/or physical examination or laboratory findings of significant diseases of cardiovascular, respiratory, neuromuscular, psychiatric diseases/disorders.
- Diseases/disorders that may contraindicate performing physical exercise or a stress test.
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 |
|---|---|---|
| LifestyleThe counselling program consists of 6 group meetings of 1 hour and 3 individual consultations of at least 15 minutes each. Sessions will be set up with the aim to enhance knowledge and empowerment related to physical activity, sedentary conducts, dietary habits, as well as strategies for behaviour change will be given. Individual consultations will focus on establishing realistic objectives and to involve the participants in taking decisions. | Behavioural | Aerobic interval training, Lifestyle counseling, Traditional continous training |
| Aerobic interval trainingThe supervised aerobic interval training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of 4 series of 4 minutes of cycling at a heart rate of 80% of the VO2peak interspersed with active pauses of 2 minutes at 60% of the VO2peak . | Behavioural | Aerobic interval training |
| Traditional continous trainingThe supervised traditional continous training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of activities such as walking, cycling, or tonification exercises always at an intensity of 60% of the VO2peak. | Behavioural | Traditional continous training |
Primary outcome
Change from baseline in metabolic risc score
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
A continuous metabolic syndrome risk score (cMSSy) will be calculated as described by Wijndaele (Wijndaele et al., 2006). The score contains the five risk factors considered in the definition of the metabolic syndrome (Expert panel on detection, 2001; Marcuello et al., 2013), that is waist circumference, triglycerides, high density lipoproteins cholesterol, systolic blood pressure and plasma glucose.
11 secondary outcomes
Change from baseline in cardiorespiratory fitness
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in active lifestyle
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in sedentary time
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in dietary habits
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in physical activity self-efficacy questionnaire
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in empowerment
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life at the end of the intervention
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in health related quality of life
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in interleucin-6
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in adiponectin
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
Change from baseline in plasma metabolome
Time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.
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 21 Aug 2019.
- Derived from this study: PubMed 32531762Ensenyat A, Espigares-Tribo G, Machado-Da-Silva L, Sinfreu-Bergues X, Blanco A. Semisupervised Physical Exercise and Lifestyle Counseling in Cardiometabolic Risk Management in Sedentary Adults: Controlled Randomized Trial (BELLUGAT). J Phys Act Health. 2020 Jun 12;17(7):744-755. doi: 10.1123/jpah.2019-0409.
- Derived from this study: PubMed 28292282Ensenyat A, Espigares-Tribo G, Machado L, Verdejo FJ, Rodriguez-Arregui R, Serrano J, Miret M, Galindo G, Blanco A, Marsal JR, Sarriegui S, Sinfreu-Bergues X, Serra-Paya N. Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT). BMC Public Health. 2017 Mar 14;17(1):257. doi: 10.1186/s12889-017-4144-8.
- Individual participant dataSharing planned: Undecided. At present we have not planned to share data. Probably at the end of the trail we will put them on the repository of the University of Lleida.
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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.
Assumpta Ensenyat, MD, PhD principal investigator
INEFC-Lleida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle, Aerobic interval training and Traditional continous training in people with Metabolic Syndrome X and Lifestyle-related Condition, run by INEFC-Lleida at 1 site in Spain.
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 4 inclusion and 4 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 from baseline in metabolic risc score (time frame: 3 time points: at baseline, 4 months (end of the intervention) and at 6 months after the end of the intervention.). 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 NCT02832453, which also lists 2 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 21 Aug 2019.