Impact of yoga on cardiovascular health in post-menopausal women: A randomized controlled clinical study

The open-label, randomized, controlled clinical study aims to evaluate the impact of yoga on cardiovascular health and low-grade inflammation in postmenopausal women.

The study will last for90 dayswith a sample size: 60 participants, 30 in each group.

Eligibility criteria:-

Inclusive criteria:

• Women in the age group 45-55 years within 5 years of menopause

• Overweight or obese women (BMI of more than or equal 23 kg/m 2 and less than or equal 35 kg/m 2 ) with either of the following conditions:

• Self-reported cardiovascular risk factor:

• Family History of cardiac disease

• Smoking

• Alcohol use

• Physical inactivity

• Stress

• Inadequate sleep

• T2DM (known or diagnosed while screening)

• Dyslipidemia (known or diagnosed while screening)

• Women ready to follow and abide by all study procedures

Exclusion criteria:

• Women with HbA1c more than or equal 7 percent
• Women with Triglycerides more than or equal 200 mg/dL and HDL less than or equal 40 mg/dL
• Women with Hemoglobin less than or equal 8 g/dL or Serum creatinine more than or equal 1.02 mg/dL
• Women with Hypertension (Systolic pressure more than 140 mm Hg and diastolic pressure more than 90 mm Hg with or without medication)
• Women with a known history of cardiovascular diseases
• Women with ST-T wave changes on electrocardiogram (ECG)
• Women who are medically unfit to practise yoga, like musculoskeletal conditions, orthopaedic conditions, etc.
• Women on any kind of medication for psychiatric illness or hormone therapy, or have undergone hysterectomy
• Women involved in intense physical activities (weight training, aerobics, gym, running) or yoga in the last 3 months

Participants who are eligible as per the criteria will be recruited from community screening and hospital-based programs and will be randomly allocated to two groups:

• Group A: Lifestyle counselling
• Group B: Yoga along with lifestyle counselling

Lifestyle counselling participant will be required to follow the lifestyle recommendation focused on nutrition, exercise, sleep, and stress management. They will be asked to download the Google Fit App on their mobile phones and enter their meals and sleep in the app. They will be instructed to send screenshots of their activity, nutrition and sleep once weekly. If the lifestyle entries in the Google Fit App are less than 24 per month, they will be withdrawn from the study.

The yoga module, based on the S-VYASA protocol, will be conducted online six days a week. For the convenience of the participants, the sessions will be conducted twice daily (morning/evening). The participant can choose any one of the 2 sessions. The participants are expected to attend a minimum of 20 sessions in a month. If the missed sessions exceed more than 20, they will be withdrawn from the study.

Assessments will be performed at baseline (Day 0) and at the end of the study (Day 90) and will include:

• Cardiovascular parameters: VO2 max (Cooper’s Test),

• Vitals: Pulse rate and blood pressure

• Anthropometry: body composition and waist & hip circumference

• Biochemical and biomarker profiling:

• Glycemic (fasting blood sugar, fasting insulin),

• Lipid (Triglycerides, hdl, ldl, total cholesterol),

• Cardiac(oxidised ldl, vascular cell adhesion molecule,nitric oxide,Amyloid-A),

• Oxidative stress(lactate dehydrogenase, 8-hydroxy-2-deoxyguanosine),

• Inflammatory(TNF-alpha, plasminogen activator inhibitor-a, adiponectin, Hs-CRP), and

• Hormonal marker(Estrogen)

• Questionnaires: MENQOL, DASS, and PSQI

Study Outcome:

1. A higher number of participants showing clinical improvement in the yoga group compared to the lifestyle counselling group

2. Greater improvement in VO2 max in the yoga group compared to the lifestyle counselling group

Optional evaluations may be done at Day 30 and Day 60, but primary endpoint analysis will focus on baseline and Day 90 data. Safety monitoring, adverse event reporting, and adherence checks (yoga attendance and lifestyle diary entries) will be performed throughout the study.

Concomitant care:

Participants will continue to take medicines for their other medical conditions, like dyslipidemia, hypertension, skin allergies, and diabetes, during the course of the study. A record of their concomitant medications will be maintained.

Dropouts and Withdrawals:

The investigator shall withdraw the subjects from the study if-

Occurrence of any medical condition or circumstance that exposes the subject to substantial risk and/or does not allow the subject to adhere to the requirements of the protocol.

Any serious adverse event (SAE), clinically significant adverse event, severe laboratory abnormality, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the subject.

Participant’s failure to comply with protocol requirements or study-related procedures.

Participants in the yoga group who attend less than 20 yoga sessions per month.

Participants who have less than 24 lifestyle entries in the Google Fit App per month.

Participants that withdraw consent.