NCT01305096

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

3.6 years

First QC Date

February 25, 2011

Last Update Submit

October 23, 2014

Conditions

Keywords

heart rate variabilityoxygen uptakeheart rate recoveryperceived stresssleepblood pressurebody mass indexbody weighthand grip strengthsleep qualitysubjective health complaintsblood lipidssalivary cortisolblood sugarHbA1CAdiponectinLeptinAdipolipoproteinsblood proteinscytokinesinsomniasleeplessnessyoga

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (14)

  • Change in anthropometric variables

    Baseline and at the end of the 8-week intervention

  • Change in common symptoms in general practice

    Baseline and at the end of the 8-week intervention

  • Change in level of sleepiness and measures of recovery or recuperation after sleep

    Baseline and at the end of the 8-week intervention

  • Change in blood pressure

    Baseline and at the end of the 8-week intervention

  • Change in hand grip strength

    Baseline and at the end of the 8-week intervention

  • +9 more secondary outcomes

Study Arms (2)

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.

Other: Yoga intervention

Control group

NO INTERVENTION

Matched control

Interventions

6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher.

Yoga group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 20-40 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Body WeightSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations