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

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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Yoga; Autonomic Nervous System
• Intervention / Treatment: Other: weekly yoga classes; Other: walk

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana
  • Maribor, Slovenia, 2000
    • UMC Maribor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: yoga; Participants in yoga group will be recruited during prenatal yoga classes at two locations: Maribor and Ljubljana. Women will be instructed to attend one class per week. Classes will consist of pregnancy-adapted yoga practices according to the system Yoga in Daily Life. They will be 90 min in duration and will consist of initial relaxation (10 to 15 min), followed by yoga postures (asanas) and stretching exercises (45 to 60 min), and final breathing (pranayama), concentration (dharana), and meditation (dhyana) techniques (20 to 30 min). Two certified yoga instructors will lead yoga classes. Measurements will be performed before and after yoga session.	Other: weekly yoga classes; Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.
ACTIVE_COMPARATOR: control; Control group will consist of healthy pregnant women attending regular prenatal visits at the departments of perinatology of the university medical centers Maribor and Ljubljana. Only women not attending any formal prenatal exercise program will be offered entrance in the study. Measurements in this group will be performed before and after a 20-30 minute walk.	Other: walk; 20-30 min easy walking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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).
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).

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University Medical Centre Maribor

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: pregnancy; yoga; cardiorespiratory synchronisation; hearth rate variability
• Other Study ID Numbers: 0120-575/2018/5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No