Cardiovascular DiseasePhase 1SAWYESNCT01667835
South Asian Women & Yoga Education Study
A Phase 1 study testing Yoga Intervention in people with Cardiovascular Disease, run by Kwantlen Polytechnic University at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2012to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
The Jim Pattison Outpatient Care and Surgery Services, Cardiovascular Outpatient Clinic
Surrey, British Columbia, V3T 0G9
Amandah L Hoogbruin, PhD, 604 599 3144, amandah.hoogbruin@kwantlen.ca
Raymond Dong, FRCP(c), 604 686 6372, raydongheart@gmail.com
- Not yet recruiting
Kwantlen Polytechnic University
Surrey, British Columbia, V3W 2M8
Amandah L Hoogbruin, PhD, 604 599 3144, amandah.hoogbruin@kwantlen.ca
Raymond Dong, FRCPC, 604 838 8418, raydongcardio@gmail.com
About this study
Official title: 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Yoga Intervention
- Keywords
- yoga, postmenopausal, sedentary South Asian women
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Intervention | Experimental | Not described Receives: Behavioral: Yoga Intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
blood pressure is measured as a specific physiologic index of cardiovascular risk.
Measured: baseline, at end of study (12 wks), & 3 months post-study
Secondary outcomes (13)
Change in subjective well-being
The Perceived Stress Scale and Abbreviated Duke Social Support Index will be used to measure subjective well-being.
Measured: baseline, at end of study (12 wks), & 3 months post-study
Change in perceived physical well-being
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
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in insulin sensitivity
Fasting insulin \& glucose will be measured for change in insulin sensitivity as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in inflammation
C-reactive protein will be measured for change in inflammation as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in serum total cholesterol
Serum total cholesterol will be measured as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in serum high-density lipoprotein (HDL) cholesterol
Serum high-density lipoprotein (HDL) cholesterol will be measured as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in serum low-density lipoprotein (LDL) cholesterol
Serum low-density lipoprotein (LDL)cholesterol will be measured as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in serum triglycerides
Serum triglycerides will be measured as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in waist circumference.
Waist circumference will be measured for change in visceral adiposity as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change waist-hip ratio
Waist-hip ratio will be measured for change in visceral adiposity as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in body mass index (BMI)
Body mass index (BMI) will be measured for change in visceral adiposity as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in resting heart rate
Resting heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
Measured: baseline, end of study (12 wks) & 3 months post-study
Change in heart rate
Heart rate will be measured for change in sympathetic activity as a related index of cardiovascular risk
Measured: baseline, at end of study (12 wks), & 3 months post-study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwantlen Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Amandah Hoogbruin, Kwantlen Polytechnic University
- Investigators
- Amandah L Hoogbruin, PhD, Principal investigator, Kwantlen Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667835
- Sponsor's protocol ID
- KK11-04
- Acronym
- SAWYES
- Status last verified
- Nov 2012
- First submitted
- 17 Jun 2012
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga for Post-menopausal South Asian Women at Risk for Cardiovascular Disease: A Randomized Control Pilot Study
- ClinicalTrials.gov ID
- NCT01667835
- Acronym / sponsor ID
- SAWYES / KK11-04
- Conditions
- Cardiovascular Disease
- Keywords
- yoga, postmenopausal, sedentary South Asian women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kwantlen Polytechnic UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Intervention | Experimental | Behavioral: Yoga Intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Intervention12 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. | Behavioural | Yoga Intervention |
Primary outcome
Change in blood pressure
Time frame: baseline, at end of study (12 wks), & 3 months post-study
blood pressure is measured as a specific physiologic index of cardiovascular risk.
13 secondary outcomes
Change in subjective well-being
Time frame: baseline, at end of study (12 wks), & 3 months post-study
Change in perceived physical well-being
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in insulin sensitivity
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in inflammation
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in serum total cholesterol
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in serum high-density lipoprotein (HDL) cholesterol
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in serum low-density lipoprotein (LDL) cholesterol
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in serum triglycerides
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in waist circumference.
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change waist-hip ratio
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in body mass index (BMI)
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in resting heart rate
Time frame: baseline, end of study (12 wks) & 3 months post-study
Change in heart rate
Time frame: baseline, at end of study (12 wks), & 3 months post-study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandah L Hoogbruin, PhD principal investigator
Kwantlen Polytechnic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yoga Intervention in people with Cardiovascular Disease, run by Kwantlen Polytechnic University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amandah L Hoogbruin, PhD (604 599 3144, amandah.hoogbruin@kwantlen.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: baseline, at end of study (12 wks), & 3 months post-study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2012.