YogaYOGADAPTNCT04476368
Effect of Yoga in Pregnancy on Cardio-respiratory Adaptation to Challenge
A study testing weekly yoga classes and walk in people with Yoga and Pregnancy, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Yoga, Pregnancy, Autonomic Nervous System
- What is being tested?
- weekly yoga classes and walk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSlovenia
- Study dates
- 1 Sep 2020to 31 May 2022
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnant women with singleton pregnancies.
Who cannot join
- Multiple pregnancies
- Cardiovascular disease (including hypertension and arrhythmias)
- Taking medications that would affect heart rate or blood pressure
- Psychiatric disorders
- Epilepsy
- Kidney disease
Show all 12Show fewer
- Liver disease
- Known fetal anomaly
- Autoimmune disorders
- Thyroid disease
- Diabetes mellitus
- Alcohol/drug abuse
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read more
The objectives of the study are:
- 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.
- Conditions
- Yoga, Pregnancy, Autonomic Nervous System
- Being tested
- weekly yoga classes, walk
- Keywords
- yoga, pregnancy, cardiorespiratory synchronisation, hearth rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
weekly yoga classesOther
Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.
walkOther
20-30 min easy walking
| Study group | Role | What they receive |
|---|---|---|
| yoga | Experimental | 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. Receives: Other: weekly yoga classes |
| control | Active comparator | 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. Receives: Other: walk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Sep 2020
- Primary completion30 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Maribor
- Responsible party
- Principal investigator, Miha Lucovnik, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476368
- Sponsor's protocol ID
- 0120-575/2018/5
- Acronym
- YOGADAPT
- Status last verified
- Jun 2022
- First submitted
- 2 Jul 2020
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Yoga in Pregnancy on Cardiovascular and Respiratory Adaptation to Acute Psychological Challenge
- ClinicalTrials.gov ID
- NCT04476368
- Acronym / sponsor ID
- YOGADAPT / 0120-575/2018/5
- Conditions
- Yoga, Pregnancy, Autonomic Nervous System
- Keywords
- yoga, pregnancy, cardiorespiratory synchronisation, hearth rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University Medical Centre Maribor
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 20 Jul 2020 (actual)
- 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.
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:
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga | Experimental | Other: weekly yoga classesParticipants 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. |
| control | Active comparator | Other: walkControl 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy pregnant women with singleton pregnancies.
Key exclusion criteria (12 listed)
- Multiple pregnancies
- Cardiovascular disease (including hypertension and arrhythmias)
- Taking medications that would affect heart rate or blood pressure
- Psychiatric disorders
- Epilepsy
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 |
|---|---|---|
| weekly yoga classesWeekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors. | Other | yoga |
| walk20-30 min easy walking | Other | control |
Primary outcome
Change in cardio-respiratory phase synchronisation index
Time frame: 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)
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 LF/HF HRV ratio.
Time frame: 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).
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.
BRS
Time frame: 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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing weekly yoga classes and walk in people with Yoga and Pregnancy, run by University Medical Centre Ljubljana at 2 sites in Slovenia.
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 1 inclusion and 12 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: finished, as of the sponsor's last update on 27 Jun 2022. 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 Slovenia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardio-respiratory phase synchronisation index (time frame: 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)). The study lists 3 primary outcomes in all. 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 27 Jun 2022.