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Resistance Training in Patients With Morbid Obesity (ExinMO)

16 april 2019 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Active comparator
Control group with obesity under Resistant Training
Övrig: 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.
Andra namn:
  • Resistant training intervention
Experimentell: Experimental group with morbid obesity
Experimental group with morbid obesity under Resistant Training
Övrig: 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.
Andra namn:
  • Resistant training intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Fasting glucose
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Body mass index
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidad de Los Lagos

Samarbetspartners

Universidad de La Frontera

Utredare

  • Studierektor: Cristian ALvarez, PhD, Universidad de Los Lagos

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 januari 2018

Primärt slutförande (Faktisk)

4 april 2018

Avslutad studie (Faktisk)

30 april 2018

Studieregistreringsdatum

Först inskickad

8 april 2019

Först inskickad som uppfyllde QC-kriterierna

16 april 2019

Första postat (Faktisk)

19 april 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 april 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 april 2019

Senast verifierad

1 april 2019

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • RP08042019

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

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Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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