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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05777044
Other study ID # Yoga RCT
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 9, 2022
Est. completion date August 1, 2023

Study information

Verified date March 2023
Source Auburn University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the effects of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45) on mental health outcomes. The main questions it aims to answer are: What is the effect of a hatha yoga intervention on depression and anxiety symptoms? What is the effect of a hatha yoga intervention on electroencephalogram (EEG) alpha and theta band power? What is the effect of hatha yoga intervention on heart rate variability? Participants will be randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). Participants in the Hatha yoga experimental group will attend 10 weeks of twice-weekly 45-minute yoga sessions. The active comparison meditation group will participate in 10 weeks of twice-weekly 45-minute meditation sessions. The control group will continue with their usual routine. Researchers will compare changes in depression and anxiety symptoms, EEG alpha and theta band power, and heart rate variability between the three groups.


Description:

There are knowledge gaps that need to be addressed in understanding the effects of yoga, specifically long-term interventions, on physiological markers, electroencephalography (EEG) and heart rate variability (HRV) and elevated mental health symptoms in young adults. The present study will address the knowledge gaps by evaluating the effect of a 10-week (2x a week; 45-minute per session) Hatha yoga intervention in adults ages 18-25 (n = 45). Participants will be truly randomized to three groups: waitlist control (usual routine), Hatha yoga (experimental group), and meditation (active comparative group). This design will allow the investigators to determine the effects of Hatha yoga on relevant outcome measures. Changes in depression symptoms (BDI), anxiety symptoms (BAI), EEG alpha and theta band power, heart rate variability indices (RMSSD, LF/HF) will be assessed. Compared to the control group, investigators hypothesize that both the Hatha yoga and meditation groups will exhibit an improvement in depression and anxiety symptoms, an increased alpha and theta band power at rest, and an increased RMSSD and decreased LF/HF at rest. Moreover, the investigators hypothesize that the Hatha yoga group will improve body composition, flexibility, muscular endurance and strength, and cardiovascular recovery more than the meditation group.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 45
Est. completion date August 1, 2023
Est. primary completion date November 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Ages 18-35 - Medically healthy to participate in physical activity as determined by the Physical Activity Reading Questionnaire (PAR-Q) - Concerned about or experiencing heightened anxiety, depression, and/or stress symptoms Exclusion Criteria: - Those with diagnosed with an intellectual or developmental disability, currently diagnosed with a concussion, physically unhealthy to participate in physical activity - Anyone currently taking beta-blockers

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga
Participation in Hatha Yoga twice a week for 45 minutes for 10 weeks. The total potential dose is 900 minutes over the course of the intervention.

Locations

Country Name City State
United States Auburn University Auburn Alabama

Sponsors (1)

Lead Sponsor Collaborator
Auburn University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary EEG Frontal (F7/F8) and Temporoparietal (TP9/TP10) Alpha and Theta EEG power. 5-minute recording at rest; measured using the MUSE-2 system and Mind Monitor application. 10 weeks
Primary Heart rate variability Root mean square of successive differences (RMSSD) and low-frequency/high-frequency ratio (LF/HF) indices of heart rate variability (HRV), 5-minute recording at rest; measured using the Polar H8/H9 HR monitors and HRVLogger application. 10 weeks
Primary Depression Beck's Depression Inventory (BDI) scores as measured by the Beck's Depression Inventory 10 weeks
Primary Anxiety Beck's Anxiety Inventory (BAI) scores as measured by the Beck's Anxiety Inventory 10 weeks
Secondary Blood Pressure Resting blood pressure will be assessed with a automatic blood pressure cuff. 10 weeks
Secondary Body Fat Percentage • Body Composition as measured by changes in body fat percentage (ratio of lean mass to fat mass) 10 weeks
Secondary Flexbility Changes in shoulder and hamstring flexibility assessed with the Fitnessgram. 10 weeks
Secondary Muscular Endurance Changes in push-up fitnessgram tests 10 weeks
Secondary Aerobic capacity 3-minute YMCA step-test which will be an index of aerobic capacity 10 weeks
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