Trial record 6 of 85 for:    Open Studies | "Stress, Psychological"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Karolinska Institutet
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Stockholm University
Information provided by (Responsible Party):
Per Wandell, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01305096
First received: February 25, 2011
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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 and breathing exercises affect heart rate variability, oxygen uptake, breathing performance, 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.


Condition Intervention
Stress, Psychological, Physiological
Behavioral: Yoga postures

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change in heart rate variability [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 respiratory function [ Time Frame: Baseline and at the end of the 8-24 week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and after the 8-week intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and at the end of the 8-week intervention ] [ Designated as safety issue: No ]
    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 respiratory funktion [ Time Frame: Baseline and at the end of the 8-24-week intervention ] [ Designated as safety issue: No ]
    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 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.


Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga group
Participants in this group will take part in 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; other yoga postures; and deep, slow breathing.
Behavioral: Yoga postures
No Intervention: Control group
Age and sex matched controls will continue their daily activities as usual with no intervention.
Active Comparator: Walking/Physio therapy
Participants will be walking or doing physical therapy during eight weeks to 24 weeks, minimum one hour per week.
Behavioral: Yoga postures

Detailed Description:

This randomized, controlled trial involving 90 male and females in Sweden will investigate whether yoga inversions and semi-inversions and other dynamic and static yoga postures and breathing exercises 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 kortisol, hand grip strength, maximal inspiratory and expiratory pressure, respiratory strength, 6 minute-walking test, 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 active walking/physiotherapy group and a passive control group. The intervention group will participate in eight to 24 weeks of yoga classes and the active walking group will perform walking/physiotherapy at the same dose as the yoga. 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 active control group will perform walking/physiotherapy at the same time as the yoga group.

The variables will be assessed at baseline; at the end of the eight-twenty four week intervention; and three, six, and twelve months after the end of the intervention.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305096

Contacts
Contact: Marian E Papp, MSc +46 706946553 marian.papp@ki.se
Contact: Per Wändell, MD, PhD +46-8-52488727 per.wandell@ki.se

Locations
Sweden
Karolinska Institute Recruiting
Stockholm, Sweden
Principal Investigator: Marian E Papp, MSc         
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Stockholm University
Investigators
Study Chair: Per Wändell, MD, PhD, Professor Karolinska Institutet
Study Chair: Petra Lindfors, PhD, Professor Stockholm University
Study Chair: Malin Nygren, PhD Karolinska Institutet
Study Chair: Lennart Gullstrand, PhD Riksidrottsförbundet
  More Information

No publications provided

Responsible Party: Per Wandell, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01305096     History of Changes
Other Study ID Numbers: 2011/248-31/1
Study First Received: February 25, 2011
Last Updated: August 6, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
stress, psychological
heart rate variability
oxygen uptake
heart rate recovery
respiratory function
inspiratory pressure
expiratory pressure
walking performance
sleep
blood pressure
signs and symptoms
body mass index
body weight
hand strength
sleep quality
common symptoms in general practice
blood lipids
salivary kortisol
blood sugar
HbA1C
Adiponectin
Leptin
Adipolipoproteins
blood proteins
cytokines

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014