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Exercise Program in Women With Metabolic Syndrome

2 november 2017 bijgewerkt door: Vera Novak, Beth Israel Deaconess Medical Center

The Effect of Mixed Aerobic and Strength Training Program on Physical Fitness and Cerebrovascular Function in Older Women With Metabolic Syndrome: A Pilot Study With Randomized Control Trial (RCT) Design

The purpose of this study is to test whether a supervised mixed aerobic and strength training (MAST) program is effective in improving overall physical fitness and blood flow in the brain and lowering risk factors of coronary artery disease (CAD) in women with metabolic syndrome.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Metabolic syndrome is a cluster of conditions and disorders that increase the risk for coronary artery disease (CAD) and strokes. Sedentary lifestyle is one of the risk factors, which decrease overall physical fitness and together with aging may lead to decrease in physical functioning in everyday life as well as changes in blood flow in the brain and cognitive functions. Regular physical activity is associated with a reduced risk of cardiovascular disease. It may also improve blood flow velocity and cognitive functions. Physical activity should be as effective as possible, but also as safe as possible. Supervised mixed aerobic and strength training (MAST) program for 4 months enables to individualize the intensity of aerobic exercise based on measured maximal exercise capacity. Throughout each training session heart rate will be monitored with a new real time wireless ECG system.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

28

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Beth Israel Deaconess Medical Center, Harvard University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Post-menopausal women
  • Age 50 or over
  • Diagnosed metabolic syndrome

Exclusion Criteria:

  • Any unstable or acute medical condition that the study physician deem unsafe for participation
  • Positive stress test for CAD or other ischemic conditions
  • Myocardial infarction or major surgery within 6 months
  • History of a clinically documented stroke
  • Clinical dementia (by history) or inability to follow details of the protocol
  • Carotid stenosis > 50% by medical history
  • Insulin dependent diabetes mellitus (also type II, if using insulin) or history of severe hypoglycemic episodes within 6 months requiring hospitalization
  • Liver or renal failure or transplant
  • Severe blood pressure elevation (systolic BP > 180 and/or diastolic BP > 110 mm Hg)
  • Anemia (Hb < 10)
  • Seizure disorders
  • Current recreational drug or alcohol abuse
  • BMI > 45, but body weight under 280 lbs
  • Inability to obtain permission for participation from the primary care physician
  • Clinically significant and movement limiting hip, knee and/or back disorders or injury, and rheumatoid arthritis
  • Transcranial Doppler (TCD) exclusion criteria - poor insonation window and TCD signal

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: MAST program
Mixed Aerobic and Strength Training program (MAST): Each exercise session consisted of 10 minutes of warm-up, 15-30 minutes of interval aerobic training by cycle ergometer according to the program, 20 minutes of strength training exercises, and 10 minutes of cool-down by stretching.
Gedragsmatig: MAST program
MAST program: twice a week for 4 months
Geen tussenkomst: UC
Usual Care (UC) with Educational Lectures: No exercise sessions.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal Oxygen Uptake
Tijdsspanne: At baseline and after 4 months of intervention
To obtain peak oxygen uptake (VO2max; ml-1/min-1/kg), a symptom-limited exercise stress test was performed on a cycle ergometer. The test was preceded by a 2-minute warm-up at the intensity of 20 W. The first test load was 20 W, and was increased by 20 W at each 2-minute stage until the participants could no longer continue, i.e., they were unable to maintain pedaling frequency > 40 rpm, they achieved a respiratory exchange ratio of more than 1.0, or clinical criteria for test termination was observed. VO2max was measured and monitored with a breath-by-breath gas exchange system.
At baseline and after 4 months of intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cerebral Blood Flow Velocity (BFV)
Tijdsspanne: At baseline and after 4 months of intervention
Cerebral BFV was monitored using Transcranial Doppler Ultrasound.11 The middle cerebral artery was insonated from the temporal window by placing the 2-MegaHertZ (MHz) probe against the skin of the temporal region above the zygomatic arch. The probe was positioned to obtain maximal BFV and was fixed at the desired angle using a 3-dimensional positioning system. Once instrumented, BFV was continuously recorded throughout ten minutes of supine rest and 10-minutes on a table tilted to 80° from the horizontal position (head-up with foot plate support).
At baseline and after 4 months of intervention
Trail Making Test
Tijdsspanne: At baseline and after 4 months of intervention
The Trail Making (TM) test is a measure of shifting attention. Participants are required to sequentially connect a series of numbered circles (Part A), and then to alternate between numbers and letters sequentially (Part B) (e.g., A-1-B-2-C-3..). Any participant who has not completed Part B within the standard 5 minutes (300 seconds) allotted for the task will be considered unable to complete the task. The scores in Part A (TM-A), Part B (TM-B) T scores ( age, education adjusted), and their difference (TM-B -TM-A) were calculated and used to measure executive function, i.e., lower scores indicates better performance.
At baseline and after 4 months of intervention
Muscle Strength
Tijdsspanne: At baseline and after 4 months of intervention
MAST sessions were held twice a week for 16 weeks. Each exercise session consisted of 10 min of warm-up, 15-30 min of interval aerobic training by cycle ergometer according to the program, 20 min of strength training exercises, and 10 min of cool-down by stretching. The target heart rate (HR) increased progressively from 50% up to 80% of HR reserve by the end of the intervention period.The Karvonen formula ([(HRmax - HRrest)×(0.50 to 0.80)] + HRrest) was used to calculate the target HR. During every training session a new wireless computerized ECG monitoring system was used. After aerobic training, the strength training program was performed. Exercises used body mass as resistance and included squat, step-up-squat, step-up, heel rise, and sit-ups. Dumbbells were used as extra weight (5 or 10% of body weight) during other exercises except for sit-ups. The control group participated in an educational session once a month and kept physical activity diaries during the intervention period.
At baseline and after 4 months of intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Beth Israel Deaconess Medical Center

Onderzoekers

  • Hoofdonderzoeker: Vera Novak, MD, PhD, Beth Israel Deaconess Medical Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2009

Primaire voltooiing (Werkelijk)

1 mei 2010

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

26 juni 2009

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2009

Eerst geplaatst (Schatting)

29 juni 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2017

Laatste update ingediend die voldeed aan QC-criteria

2 november 2017

Laatst geverifieerd

1 november 2017

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2009P000121

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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