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South Asian Women & Yoga Education Study (SAWYES)

16 novembre 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Anticipato)

50

Fase

  • Fase 1

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

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0G9
        • Reclutamento
        • The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
        • Contatto:
        • Contatto:
      • Surrey, British Columbia, Canada, V3W 2M8
        • Non ancora reclutamento
        • Kwantlen Polytechnic University
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Amandah L Hoogbruin, PhD

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 40 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Femmina

Descrizione

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

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: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Controllo
Sperimentale: Intervento sullo yoga
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in blood pressure
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in subjective well-being
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

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

Sponsor

Kwantlen Polytechnic University

Investigatori

  • Investigatore principale: Amandah L Hoogbruin, PhD, Kwantlen Polytechnic University

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

1 novembre 2012

Completamento primario (Anticipato)

1 dicembre 2014

Completamento dello studio (Anticipato)

1 agosto 2015

Date di iscrizione allo studio

Primo inviato

17 giugno 2012

Primo inviato che soddisfa i criteri di controllo qualità

14 agosto 2012

Primo Inserito (Stima)

17 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

19 novembre 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 novembre 2012

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • KK11-04

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 .

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