Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Resistance Training in Patients With Morbid Obesity (ExinMO)

16 aprile 2019 aggiornato da: Universidad de Los Lagos

Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence

The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.

Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

39

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Chile
    • Llanquihue
      • Osorno, Llanquihue, Chile, 5290000
        • Cristian ALvarez

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

Inclusion Criteria:

  • Older than 18 and younger and ≤65 years of age.
  • With risk factors to Metabolic syndrome
  • With obesity and morbid obesity condition
  • Medical authorization by a physician.

Exclusion Criteria:

  • Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
  • Exercise-related dyspnoea or respiratory alterations.
  • Chronic heart disease with any worsening in the last month.
  • Adherence rate of less than 80% of the total interventions.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Active comparator
Control group with obesity under Resistant Training
Altro: Behavioral
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Altri nomi:
  • Resistant training intervention
Sperimentale: Experimental group with morbid obesity
Experimental group with morbid obesity under Resistant Training
Altro: Behavioral
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Altri nomi:
  • Resistant training intervention

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fasting glucose
Lasso di tempo: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Change from Baseline Fasting glucose at 20-weeks of Resistant Training
High density lipoprotein
Lasso di tempo: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Systolic blood pressure and diastolic blood pressure
Lasso di tempo: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Component of the Metabolic Syndrome
from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Waist circumference
Lasso di tempo: Change from Baseline Waist circumference at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Change from Baseline Waist circumference at 20-weeks of Resistant Training
Triglycerides
Lasso di tempo: Change from Baseline Triglycerides at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Change from Baseline Triglycerides at 20-weeks of Resistant Training

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Body mass index
Lasso di tempo: Change from Baseline Body mass index at 20-weeks of Resistant Training
Anthropometric
Change from Baseline Body mass index at 20-weeks of Resistant Training
Body mass
Lasso di tempo: Change from Baseline Body mass at 20-weeks of Resistant Training
Anthropometric
Change from Baseline Body mass at 20-weeks of Resistant Training
Total cholesterol
Lasso di tempo: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Measured by plasma sample
Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Low density lipoprotein
Lasso di tempo: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Measured by plasma sample
Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Six minutes walking test
Lasso di tempo: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
Endurance performance
Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
One maximum repetition of biceps curl
Lasso di tempo: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Strength Performance
Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Handgrip muscle strength
Lasso di tempo: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
Muscle strength
Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universidad de Los Lagos

Collaboratori

Universidad de La Frontera

Investigatori

  • Direttore dello studio: Cristian ALvarez, PhD, Universidad de Los Lagos

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2018

Completamento primario (Effettivo)

4 aprile 2018

Completamento dello studio (Effettivo)

30 aprile 2018

Date di iscrizione allo studio

Primo inviato

8 aprile 2019

Primo inviato che soddisfa i criteri di controllo qualità

16 aprile 2019

Primo Inserito (Effettivo)

19 aprile 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 aprile 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 aprile 2019

Ultimo verificato

1 aprile 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • RP08042019

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The participants information will be available by e-mail according with researchers requirements.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Behavioral

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Germany

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi