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Resistance Training in Patients With Morbid Obesity (ExinMO)

16. April 2019 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

39

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Active comparator
Control group with obesity under Resistant Training
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.
Andere Namen:
  • Resistant training intervention
Experimental: Experimental group with morbid obesity
Experimental group with morbid obesity under Resistant Training
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.
Andere Namen:
  • Resistant training intervention

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fasting glucose
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Body mass index
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Januar 2018

Primärer Abschluss (Tatsächlich)

4. April 2018

Studienabschluss (Tatsächlich)

30. April 2018

Studienanmeldedaten

Zuerst eingereicht

8. April 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

16. April 2019

Zuerst gepostet (Tatsächlich)

19. April 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

16. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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