NCT06304662

Brief Summary

In the university environment, where academic pressure and personal exploration are paramount, yoga serves as a sanctuary for students facing stress and seeking self-discovery. Through practices like asanas, pranayama, and meditation, yoga equips students with tools to manage stress, foster inner balance, and enhance emotional well-being. Apart from its emotional benefits, yoga offers physical advantages, improving strength, flexibility, and posture, particularly beneficial for those sedentary due to academic demands. Moreover, yoga enhances concentration and mental clarity through mindfulness practices, aiding students in academic focus and problem-solving.Additionally, yoga provides a space for students to disconnect from external stimuli and recharge, reducing mental and physical fatigue while boosting vitality. By integrating yoga into university life, students can better balance academic pressures with personal care, laying the groundwork for a more harmonious and mindful future.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 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

Study Start

First participant enrolled

November 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2024

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

March 3, 2024

Last Update Submit

May 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stress level

    Perceived Stress Scale (PSS). This scale is a self-report instrument that evaluates the level of perceived stress during the last month, it consists of 14 items with a response format of a five-point scale (0 = never, 1 = almost never, 2 = occasionally when, 3 = often, 4 = very often). The total score of the PSS is obtained by reversing the scores of items 4, 5, 6, 7, 9, 10 and 13 (in the following sense: 0=4, 1=3, 2=2, 3=1 and 4 =0) and then adding the 14 items. The direct score obtained indicates that a higher score corresponds to a higher level of perceived stress.

    Up to twelve weeks

Secondary Outcomes (7)

  • D2 test

    Up to twelve weeks

  • Mindful Attention Awareness Scale (MAAS)

    Up to twelve weeks

  • Handgrip Strength

    Up to twelve weeks

  • Anxiety and Depression

    Up to twelve weeks

  • Sleep quality

    Up to twelve weeks

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

The control group (CG) that is not going to undergo treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity, and they will be given the guide of recommendations for the promotion of physical activity.

Experimental Group

EXPERIMENTAL

The experimental group (EG) that after an initial evaluation will be subjected to a physical training program based on the ERFS, for 12 weeks with 3 weekly sessions (Monday, Wednesday and Friday), with a duration of 30-45 min per session. Once the intervention is finished, a final evaluation will be used again to see if there is a difference or not with the results obtained at the beginning.

Other: Yoga intervention

Interventions

Over 12 weeks, students will attend 50-minute yoga sessions twice a week. Sessions start with 10 minutes of mindful breathing and gentle warm-up movements, followed by 30 minutes of tailored yoga postures for relaxation and stretching. Students progress from basic to advanced postures, with adaptations for individual needs. Each session ends with a guided meditation for inner calm. A 10-minute cool-down encourages deep relaxation. Emphasis is on stress reduction, flexibility, and mindfulness, tailored to university life challenges. Continuous assessment ensures sessions meet students' evolving needs and optimize yoga's benefits in the university setting.

Experimental Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • University students who do not participate in any physical exercise program
  • Sufficient physical autonomy to participate in the physical activities required by the study
  • That they are able to understand the instructions, programs and protocols of this project.

You may not qualify if:

  • Lack of commitment to regular attendance
  • Extensive previous experience in yoga

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agustín Aibar Almazán

Jaén, 23007, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 3, 2024

First Posted

March 12, 2024

Study Start

November 13, 2023

Primary Completion

February 9, 2024

Study Completion

February 19, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations