Effect of Yoga in Pregnancy on Cardio-respiratory Adaptation to Challenge

Pregnancy Clinical Trial

— YOGADAPT  

Official title:

Effect of Yoga in Pregnancy on Cardiovascular and Respiratory Adaptation to Acute Psychological Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04476368
• Other study ID #: 0120-575/2018/5
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Yoga has received considerable attention for its potential therapeutic benefits over the past decades and it gradually became object of scientific scrutiny. There is currently extensive literature supporting its use as a non-pharmacological tool for managing a variety of medical problems. A few studies have also explored potential beneficial effects of practising yoga during pregnancy on maternal and neonatal outcomes. An association between prenatal yoga and decreased incidence of fetal growth restriction, preterm delivery, and labor abnormalities resulting in operative delivery have been reported.

Exact mechanisms by which yoga could improve perinatal outcomes have not been elucidated yet. One of such mechanisms could be the positive effect of yoga on autonomic nervous system (ANS). Maternal cardiovascular system undergoes profound changes during pregnancy and ANS plays a central role in adaptation to pregnancy-related hemodynamic changes. Increase in peripheral vascular resistance that characterises hypertensive disorders in pregnancy with fetal growth restriction is mediated by substantial increase in sympathetic vasoconstrictor activity. Effects of yoga on ANS outside of pregnancy have already been investigated in several studies. Heart rate variability (HRV) indices, used as a one of proxy measures for ANS activity, showed significant shifts towards parasympathetic dominance following yoga sessions. Another objective means of assessing ANS activity is measurement of phase synchronisation between cardiovascular and respiratory systems following acute challenge. The higher the cardiorespiratory synchronisation after acute challenge is, the higher is the ability of ANS to flexibly adapt to challenge.

The objectives of the study are:

I. To examine whether there is a short-term shift in autonomic balance to the parasympathetic branch of the ANS and ability of the cardiovascular and respiratory respiratory systems to flexibly adapt to acute psychological challenge following sessions in pregnancy.

II. To investigate potential long- term effects of yoga practice during pregnancy on HRV and cardio-respiratory synchronisation following acute psychological challenge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 31, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy pregnant women with singleton pregnancies.

Exclusion Criteria:

• Multiple pregnancies

• Cardiovascular disease (including hypertension and arrhythmias)

• Taking medications that would affect heart rate or blood pressure

• Psychiatric disorders

• Epilepsy

• Kidney disease

• Liver disease

• Known fetal anomaly

• Autoimmune disorders

• Thyroid disease

• Diabetes mellitus

• Alcohol/drug abuse

Related Conditions & MeSH terms

• Autonomic Nervous System
• Pregnancy
• Yoga

Intervention

Other:
• weekly yoga classes
Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.
• walk
20-30 min easy walking

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana
Slovenia	UMC Maribor	Maribor

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University Medical Centre Maribor

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardio-respiratory phase synchronisation index	Cardio-respiratory phase synchronisation index measures synchronisation between the cardiovascular and respiratory system following acute psychological challenge. It's value is between 0 (no synchronisation) and 1 (complete synchronisation). The higher the value, the higher the ability of cardiovascular and respiratory systems to flexibly adapt to challenge (standardised memory task).	Change in cardio-respiratory phase synchronisation index from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk)
Primary	Change in LF/HF HRV ratio.	For frequency related HRV indices, we will run an autoregressive spectral analysis using Burg's algorithm (model order 24) after resampling and removing the trend of 2nd order. Low frequency (LF) will be defined as 0.04 - 0.15 Hz, high frequency (HF) will be defined as 0.15 - 0.40 Hz. The higher the LF/HF HRV ratio, the lower the parasympathetic tone.	Change in LF/HF HRV ratio from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).
Primary	BRS	The sequence technique will be used for the assessment of baroreceptor sensitivity (BRS). This technique is based on identifying consecutive cardiac beats in which an increase in systolic blood pressure is accompanied by an increase in heart rate, or in which a decrease in systolic blood pressure is accompanied by a decrease in heart rate. The regression line between the systolic blood pressure and heart rate produces an estimate of BRS. The higher the BRS, the higher the parasympathetic tone.	Change in BRS from baseline (measured up to 30 minutes before yoga class/walk) to the end of exercise (measured up to 30 minutes after the end of yoga class/walk).