Clinical trial NCT03428542: Yoga and Psychological and Physiological Health
Official title: The Effects of Yoga on Psychological and Physiological Health in a Population Based Cohort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depression
Sleep
Physiological Stress
Keywords: yoga
stress
anxiety
depression
sleep quality
physiological stress
biomarkers
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2018-02-09
Enrollment: 105
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-group RCT with three arms during 5 weeks. Subjects were randomized to a control group, the Yin Yoga intervention group or the YOMI intervention group. YOMI intervention combines Yin yoga with psychoeducation and mindfulness practice.
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the benefits of yoga as a 'mind-body' practice, by measuring it's effects on health-related psychological and physiological variables. The study also aims to investigate whether an association exists between subjective (psychological) and objective (physiological) measures, with a particular focus on stress as the primary outcome.

Detailed description: Stress and worry in everyday life are common features of Western society. Stress is a biological mechanism tapping the fight-or-flight-response via activation of the sympathetic nervous system. When exposed to stress during prolonged periods of time, the immune system is affected, leading to physiological as well as psychosocial problems. The consequences of untreated high stress can not only turn into reduced job capacity, and work roles conflicts, but also into cardiovascular disease, and mental illness such as an anxiety disorder or/and depression.

One common and recommended strategy to manage stress is to exercise regularly. Yoga is an umbrella term for a wide variety of physical, mental, and spiritual practices with its roots in ancient India. Most previous research on the health effects of yoga has demonstrated benefits on psychological health factors including mental stress, anxiety, depression and sleep problems.

The aim of the study is thus to investigate the effects of two types of yoga intervention on psychological and physiological health.

Eligibility criteria: Inclusion Criteria:

* A score on four items of the Perceived Stress Scale between 8-16, thereby indicating a current stress experience of at least moderate level.
* Ability to participate in the intervention during the time-period.
* Comprehensive in Swedish.

Exclusion Criteria:

* Ongoing yoga practice or any regular practice of yoga or meditation within the last 6 months.
* Any known physical limitations that may prevent light physical activity (yoga postures).
* Current psychological or psychopharmacological treatment.
* Inability to attend more than 5 of the scheduled 10 yoga sessions.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: 5 weeks
measure: The Hospital Anxiety and Depression Scale
timeFrame: 5 weeks
measure: The COPE Inventory
timeFrame: 5 weeks
measure: The Insomnia Severity Index
timeFrame: 5 weeks
measure: Diet
timeFrame: 5 weeks
measure: General Health Questionnaire
timeFrame: 5 weeks
measure: The Harmony in Life Scale
timeFrame: 5 weeks
measure: The Kentucky Inventory of Mindfulness Skills -Short Version
timeFrame: 5 weeks
measure: The Brief Experiential Avoidance Questionnaire
timeFrame: 5 weeks
measure: The Self-Compassion Scale
timeFrame: 5 weeks
measure: Fasting blood sampling
timeFrame: 5 weeks
measure: Fasting and 120-minute glucose tolerance test (mmol/L)
timeFrame: 5 weeks
measure: Office and 24-hour blood pressure measurement (mmHg)
timeFrame: 5 weeks
measure: Pulse-wave velocity
timeFrame: 5 weeks
measure: Heart rate variability
timeFrame: 5 weeks
measure: Gut microbiota
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: KFE, Skåne University Hospital in Malmö
Study officials:
affiliation: Lund University
name: Olle Melander, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daukantaite D, Tellhed U, Maddux RE, Svensson T, Melander O. Five-week yin yoga-based interventions decreased plasma adrenomedullin and increased psychological health in stressed adults: A randomized controlled trial. PLoS One. 2018 Jul 18;13(7):e0200518. doi: 10.1371/journal.pone.0200518. eCollection 2018.