- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01667835
South Asian Women & Yoga Education Study (SAWYES)
16. November 2012 aktualisiert von: 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.
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
50
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
British Columbia
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Surrey, British Columbia, Kanada, V3T 0G9
- Rekrutierung
- The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
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Kontakt:
- Amandah L Hoogbruin, PhD
- Telefonnummer: 604 599 3144
- E-Mail: amandah.hoogbruin@kwantlen.ca
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Kontakt:
- Raymond Dong, FRCP(c)
- Telefonnummer: 604 686 6372
- E-Mail: raydongheart@gmail.com
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Surrey, British Columbia, Kanada, V3W 2M8
- Noch keine Rekrutierung
- Kwantlen Polytechnic University
-
Kontakt:
- Amandah L Hoogbruin, PhD
- Telefonnummer: 604 599 3144
- E-Mail: amandah.hoogbruin@kwantlen.ca
-
Kontakt:
- Raymond Dong, FRCPC
- Telefonnummer: 604 838 8418
- E-Mail: raydongcardio@gmail.com
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Hauptermittler:
- Amandah L Hoogbruin, PhD
-
-
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
40 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Kontrolle
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in blood pressure
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in subjective well-being
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: baseline, end of study (12 wks) & 3 months post-study
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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.
Zeitfenster: 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
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baseline, end of study (12 wks) & 3 months post-study
|
Change waist-hip ratio
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Amandah L Hoogbruin, PhD, Kwantlen Polytechnic University
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
1. November 2012
Primärer Abschluss (Voraussichtlich)
1. Dezember 2014
Studienabschluss (Voraussichtlich)
1. August 2015
Studienanmeldedaten
Zuerst eingereicht
17. Juni 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. August 2012
Zuerst gepostet (Schätzen)
17. August 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
19. November 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. November 2012
Zuletzt verifiziert
1. November 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KK11-04
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