Stress, Psychological, Physiological Clinical Trial
Official title:
Effects of Yoga on Objective and Self-reported Health Indicators Among Female and Male Individuals
| Verified date | October 2014 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Sweden: Regional Ethical Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 44 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 40 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institute | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Stockholm County Council, Sweden, Stockholm University |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | Baseline and at the end of the 8-week intervention | No |
| Primary | 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. | Baseline and at the end of the 8 week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |
| Secondary | 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. | Baseline and after the 8-week intervention | No |
| Secondary | 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. | Baseline and at the end of the 8-week intervention | No |