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South Asian Women & Yoga Education Study (SAWYES)

16. november 2012 opdateret af: Dr. Amandah Hoogbruin, Kwantlen Polytechnic University

Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study

The purpose of this randomized, control pilot study is to measure the effects of a gentle, 12 week hatha yoga program on post-menopausal, obese, sedentary South Asian women at risk for cardiovascular disease. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

50

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0G9
        • Rekruttering
        • The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
        • Kontakt:
        • Kontakt:
      • Surrey, British Columbia, Canada, V3W 2M8
        • Ikke rekrutterer endnu
        • Kwantlen Polytechnic University
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Amandah L Hoogbruin, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • 40- 65 years old
  • Postmenopausal (amenorrhea for ≥ 12 months)
  • Overweight as evidenced by a body mass index (BMI) ≥ 25 kg/m2), or waist circumference ≥ 80 cm, or have a first degree relative with diabetes or essential hypertension
  • Sedentary, do not do a regular exercise program (exercising for 20 minutes at sufficient intensity to produce sweating less than 2x/week)
  • Self-identify as a South Asian (sometimes referred to as East Indian in Canada and may be defined "as any person who reports an ethnicity associated with the southern part of Asia or who self-identifies as part of the South Asian visible minority group. This definition encompasses people from a great diversity of ethnic backgrounds, including those with Bangladeshi, Bengali, East Indian, Goan, Gujarati, Hindu, Ismaili, Kashmiri, Nepali, Pakistani, Punjabi, Sikh, Sinhalese, South Asian, Sri Lankan and Tamil ancestry. South Asians may have been born in Canada, on the Indian sub-continent, in the Caribbean, in Africa, in Great Britain or elsewhere
  • Given consent to research protocol and willingness to be randomized to either the treatment (yoga) or control (no yoga) group.

Exclusion Criteria:

  • Have had a period within the last year
  • Are not between the ages of 40 and 65
  • Have experience with yoga within the last 12 months
  • Have any serious disease or condition such as diabetes, serious high blood pressure or heart problems, kidney disease, severe asthma, cancer (except for skin cancer that is not melanoma)
  • Have a major brain or nervous system diagnosis, such as Parkinson's disease or stroke
  • Have a severe infectious or other medical illness right now such as pneumonia
  • Use medications to lower blood sugar levels
  • Have serious back, hip, or neck problems or pain in joints or bones that would prevent the safe completion of a gentle 12 week Hatha yoga program
  • Regularly use an assistive device (e.g., cane, walker) to walk

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Styring
Eksperimentel: Yoga intervention
Adfærdsmæssigt: Yoga Intervention
12 week 90 minute hatha yoga session offered three (3x) per week. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in blood pressure
Tidsramme: baseline, at end of study (12 wks), & 3 months post-study
blood pressure is measured as a specific physiologic index of cardiovascular risk.
baseline, at end of study (12 wks), & 3 months post-study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in subjective well-being
Tidsramme: baseline, at end of study (12 wks), & 3 months post-study
The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.
baseline, at end of study (12 wks), & 3 months post-study
Change in perceived physical well-being
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Pittsburgh Sleep Quality Index, Physical Activity Scale for the Elderly, and Exercise Regularly Scale will be used to measure change in perceived physical well-being
baseline, end of study (12 wks) & 3 months post-study
Change in insulin sensitivity
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Fasting insulin & glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in inflammation
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in serum total cholesterol
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Serum total cholesterol will be measured as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in serum high-density lipoprotein (HDL) cholesterol
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in serum low-density lipoprotein (LDL) cholesterol
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in serum triglycerides
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Serum triglycerides will be measured as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in waist circumference.
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change waist-hip ratio
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in body mass index (BMI)
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in resting heart rate
Tidsramme: baseline, end of study (12 wks) & 3 months post-study
Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
baseline, end of study (12 wks) & 3 months post-study
Change in heart rate
Tidsramme: baseline, at end of study (12 wks), & 3 months post-study
Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
baseline, at end of study (12 wks), & 3 months post-study

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kwantlen Polytechnic University

Efterforskere

  • Ledende efterforsker: Amandah L Hoogbruin, PhD, Kwantlen Polytechnic University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. november 2012

Primær færdiggørelse (Forventet)

1. december 2014

Studieafslutning (Forventet)

1. august 2015

Datoer for studieregistrering

Først indsendt

17. juni 2012

Først indsendt, der opfyldte QC-kriterier

14. august 2012

Først opslået (Skøn)

17. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. november 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2012

Sidst verificeret

1. november 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KK11-04

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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