Clinical trial NCT04476368: Effect of Yoga in Pregnancy on Cardio-respiratory Adaptation to Challenge
Official title: Effect of Yoga in Pregnancy on Cardiovascular and Respiratory Adaptation to Acute Psychological Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Pregnancy
Autonomic Nervous System
Keywords: yoga
pregnancy
cardiorespiratory synchronisation
hearth rate variability
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University Medical Centre Maribor
First posted: 2020-07-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in cardio-respiratory phase synchronisation index
timeFrame: 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)
measure: Change in LF/HF HRV ratio.
timeFrame: 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).
measure: BRS
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
city: Maribor
country: Slovenia
facility: UMC Maribor
Study officials:
References: