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Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals

Primary Purpose

Stress, Psychological, Physiological

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Yoga intervention
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological, Physiological focused on measuring 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, insomnia, sleeplessness, yoga

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 20-40 years old

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Karolinska Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Yoga group

Control group

Arm Description

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.

Matched control

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 25, 2011
Last Updated
October 23, 2014
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Stockholm University
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1. Study Identification

Unique Protocol Identification Number
NCT01305096
Brief Title
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
Official Title
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm, Stockholm University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Physiological
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, insomnia, sleeplessness, yoga

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Matched control
Intervention Type
Other
Intervention Name(s)
Yoga intervention
Intervention Description
6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher.
Primary Outcome Measure Information:
Title
Change in heart rate variability
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in oxygen uptake
Description
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.
Time Frame
Baseline and at the end of the 8 week intervention
Secondary Outcome Measure Information:
Title
Change in anthropometric variables
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in common symptoms in general practice
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in level of sleepiness and measures of recovery or recuperation after sleep
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in blood pressure
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in hand grip strength
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in measures of relaxation and recovery
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in perceived stress
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in self-rated health
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in rating of perceived exertion
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in satisfaction with life
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in level of work-family conflict
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in HbA1C
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention
Title
Change in Apolipoproteins
Description
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.
Time Frame
Baseline and after the 8-week intervention
Title
Change in Adiponectin/Leptin ratio
Description
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.
Time Frame
Baseline and at the end of the 8-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 20-40 years old Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Wändell, MD, PhD, Professor
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Petra Lindfors, PhD, Professor
Organizational Affiliation
Stockholm University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Malin Nygren, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lennart Gullstrand, PhD
Organizational Affiliation
Riksidrottsförbundet
Official's Role
Study Chair
Facility Information:
Facility Name
Karolinska Institute
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31733760
Citation
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.
Results Reference
derived

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Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals

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