Stress, Psychological, PhysiologicalNCT01305096
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
A study testing Yoga intervention in people with Stress, Psychological, Physiological, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether inversions (specific yoga postures in which the heart is higher than the head) and other dynamic and static yoga postures affect heart rate variability, oxygen uptake, blood pressure, blood parameters and other objective measures of health, and a variety of subjective… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Physiological
- What is being tested?
- Yoga intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2011to Oct 2014
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 20-40 years old
Who cannot join
- Aged 40 or more years
- Takes medication for high blood pressure or other strong medication
- Recently had an operation
- Diagnosed with eye disease (e.g., glaucoma)
- Diagnosed with depression or burnout syndrome
- Diagnosed with serious back or neck problems
Show all 9Show fewer
- Participates in intense physical activity more than once a week
- Has digestive problems such as acid reflux
- Serious disorder that affects the ability to do the yoga postures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether inversions (specific yoga postures in which the heart is higher than the head) and other dynamic and static yoga postures affect heart rate variability, oxygen uptake, blood pressure, blood parameters and other objective measures of health, and a variety of subjective and objective measures of health in female and male individuals in Sweden.
Read the detailed description
This randomized, controlled trial involving 44 male and females in Sweden will investigate whether yoga inversions and semi-inversions and other dynamic and static yoga postures will affect the following variables: heart rate variability, oxygen uptake, anthropometric variables, common symptoms in general practice, sleepiness, sleep quality and recovery/recuperation after sleep, blood pressure, blood lipids, blood proteins, blood sugar, salivary cortisol, hand grip strength, relaxation and recovery perceived stress, self-rated health, rating of perceived exertion, satisfaction with life, and work-family conflict.
Participants will be divided into an intervention group and a passive control group. The intervention group will participate in six to ten weeks of yoga classes. The classes will be held 1-2 times a week for approximately one hour each and will include yoga poses and breathing techniques. The control group will not participate in any intervention but will conduct their lives as usual.
The variables will be assessed at baseline; at the end of the intervention; and three, six, and twelve months after the end of the intervention.
- Conditions
- Stress, Psychological, Physiological
- Being tested
- Yoga intervention
- Keywords
- heart rate variability, oxygen uptake, heart rate recovery, perceived stress, sleep, blood pressure, body mass index, body weight, hand grip strength, sleep quality, subjective health complaints, blood lipids, salivary cortisol, blood sugar, HbA1C, Adiponectin, Leptin, Adipolipoproteins, blood proteins, cytokines
- Medical subject headings
- Body Weight, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga interventionOther
6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | Participants in this group will take part in six to eight weeks of yoga classes. The classes will be held once a week and each class will be approximately one hour long. The classes will consist of yoga inversions, sun salutations and other yoga postures with deep breathing. Receives: Other: Yoga intervention |
| Control group | No intervention | Matched control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in oxygen uptake
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8 week intervention
Secondary outcomes (14)
Change in anthropometric variables
Anthropometric variables include height, weight, waist-to-hip ratio, and body mass index(BMI). We will measure the change in these variables over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in common symptoms in general practice
We will use the Common Symptoms in General Practice Index to measure how often over the past four weeks participants have experienced the fifteen most common health-related symptoms and complaints. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in level of sleepiness and measures of recovery or recuperation after sleep
The Karolinska Sleepiness Scale will be used to measure this outcome variable. This scale measures degree of wakefulness at bedtime and after waking in the morning. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in blood pressure
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects at the end of the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in hand grip strength
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in measures of relaxation and recovery
We will measure the change in these variables over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in perceived stress
The Perceived Stress Scale will be used to measure this variable. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in self-rated health
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in rating of perceived exertion
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in satisfaction with life
This variable will be measured with the Satisfaction With Life Scale. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in level of work-family conflict
This variable will be measured with the Work-Family Conflict Scale. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in HbA1C
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Change in Apolipoproteins
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and after the 8-week intervention
Change in Adiponectin/Leptin ratio
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Measured: Baseline and at the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, Psychological, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Stockholm University
- Responsible party
- Principal investigator, Per Wandell, Karolinska Institutet
- Investigators
- Per Wändell, MD, PhD, Professor, Study chair, Karolinska InstitutetPetra Lindfors, PhD, Professor, Study chair, Stockholm UniversityMalin Nygren, PhD, Study chair, Karolinska InstitutetLennart Gullstrand, PhD, Study chair, Riksidrottsförbundet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305096
- Sponsor's protocol ID
- 2011/248-31/1
- Status last verified
- Oct 2014
- First submitted
- 25 Feb 2011
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Papp ME, Nygren-Bonnier M, Gullstrand L, Wandell PE, Lindfors P. A randomized controlled pilot study of the effects of 6-week high intensity hatha yoga protocol on health-related outcomes among students. J Bodyw Mov Ther. 2019 Oct;23(4):766-772. doi: 10.1016/j.jbmt.2019.05.013. Epub 2019 May 15.
PubMed 31733760
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
- ClinicalTrials.gov ID
- NCT01305096
- Acronym / sponsor ID
- 2011/248-31/1
- Conditions
- Stress, Psychological, Physiological
- Keywords
- heart rate variability, oxygen uptake, heart rate recovery, perceived stress, sleep, blood pressure, body mass index, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Stockholm University
- Study start
- Mar 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Feb 2011 (estimated)
- 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.
The purpose of this study is to determine whether inversions (specific yoga postures in which the heart is higher than the head) and other dynamic and static yoga postures affect heart rate variability, oxygen uptake, blood pressure, blood parameters and other objective measures of health, and a variety of subjective and objective measures of health in female and male individuals in Sweden.
Detailed description
This randomized, controlled trial involving 44 male and females in Sweden will investigate whether yoga inversions and semi-inversions and other dynamic and static yoga postures will affect the following variables: heart rate variability, oxygen uptake, anthropometric variables, common symptoms in general practice, sleepiness, sleep quality and recovery/recuperation after sleep, blood pressure, blood lipids, blood proteins, blood sugar, salivary cortisol, hand grip strength, relaxation and recovery perceived stress, self-rated health, rating of perceived exertion, satisfaction with life, and work-family conflict.
Participants will be divided into an intervention group and a passive control group. The intervention group will participate in six to ten weeks of yoga classes. The classes will be held 1-2 times a week for approximately one hour each and will include yoga poses and breathing techniques. The control group will not participate in any intervention but will conduct their lives as usual.
The variables will be assessed at baseline; at the end of the intervention; and three, six, and twelve months after the end of the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: Yoga interventionParticipants in this group will take part in six to eight weeks of yoga classes. The classes will be held once a week and each class will be approximately one hour long. The classes will consist of yoga inversions, sun salutations and other yoga postures with deep breathing. |
| Control group | No intervention | –Matched control |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 20-40 years old
Key exclusion criteria (9 listed)
- Aged 40 or more years
- Takes medication for high blood pressure or other strong medication
- Recently had an operation
- Diagnosed with eye disease (e.g., glaucoma)
- Diagnosed with depression or burnout syndrome
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 |
|---|---|---|
| Yoga intervention6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher. | Other | Yoga group |
Primary outcome
Change in heart rate variability
Time frame: Baseline and at the end of the 8-week intervention
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
Change in oxygen uptake
Time frame: Baseline and at the end of the 8 week intervention
We will measure the change in this variable over time. The first measurement will be at baseline and the second at the end of the 8-week intervention (main measurement). If and only if there are effects after the 8-week intervention, we will follow up the participants at various intervals to determine how long the effects are sustained. These follow-ups will be conducted 3 months, 6 months, and 12 months after the end of the intervention.
14 secondary outcomes
Change in anthropometric variables
Time frame: Baseline and at the end of the 8-week intervention
Change in common symptoms in general practice
Time frame: Baseline and at the end of the 8-week intervention
Change in level of sleepiness and measures of recovery or recuperation after sleep
Time frame: Baseline and at the end of the 8-week intervention
Change in blood pressure
Time frame: Baseline and at the end of the 8-week intervention
Change in hand grip strength
Time frame: Baseline and at the end of the 8-week intervention
Change in measures of relaxation and recovery
Time frame: Baseline and at the end of the 8-week intervention
Change in perceived stress
Time frame: Baseline and at the end of the 8-week intervention
Change in self-rated health
Time frame: Baseline and at the end of the 8-week intervention
Change in rating of perceived exertion
Time frame: Baseline and at the end of the 8-week intervention
Change in satisfaction with life
Time frame: Baseline and at the end of the 8-week intervention
Change in level of work-family conflict
Time frame: Baseline and at the end of the 8-week intervention
Change in HbA1C
Time frame: Baseline and at the end of the 8-week intervention
Change in Apolipoproteins
Time frame: Baseline and after the 8-week intervention
Change in Adiponectin/Leptin ratio
Time frame: Baseline and at the end of the 8-week intervention
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 24 Oct 2014.
- Derived from this study: PubMed 31733760Papp ME, Nygren-Bonnier M, Gullstrand L, Wandell PE, Lindfors P. A randomized controlled pilot study of the effects of 6-week high intensity hatha yoga protocol on health-related outcomes among students. J Bodyw Mov Ther. 2019 Oct;23(4):766-772. doi: 10.1016/j.jbmt.2019.05.013. Epub 2019 May 15.
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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.
Per Wändell, MD, PhD, Professor study chair
Karolinska Institutet
Petra Lindfors, PhD, Professor study chair
Stockholm University
Malin Nygren, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga intervention in people with Stress, Psychological, Physiological, run by Karolinska Institutet at 1 site in Sweden.
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 9 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 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 heart rate variability (time frame: Baseline and at the end of the 8-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305096, which also lists 1 linked publication.
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 24 Oct 2014.