NCT06979830

Brief Summary

Obesity has been defined by the World Health Organization (WHO) as an abnormal accumulation of fat in the body that negatively affects health and has been reported to be the most significant public health problem of the 21st century. In the late 1990s, WHO described obesity as a "global epidemic." This epidemic and its associated complications cause the death of 2.8 million adults annually. Additionally, obesity imposes a significant financial burden on countries' healthcare and social security systems. Therefore, obesity stands out as an issue that requires urgent preventive measures. Obesity is associated with various abnormalities in respiratory functions. Changes in respiratory system mechanics due to decreased lung volumes indicate a strong link between obesity and chronic respiratory diseases. Furthermore, obesity is a risk factor for conditions such as hypertension, cardiovascular diseases, and diabetes. Yoga is known to have numerous positive effects on health and can provide significant benefits, particularly in improving respiratory functions. Yoga is also an important tool for coping with stress, which can positively influence the respiratory system. It has been reported that yoga reduces the impact of stress on respiratory rate, promoting deep breathing and relaxation. Some studies on the effects of yoga on obesity have not reached significant conclusions. A study comparing the effects of Vinyasa and Hatha yoga on obesity management found that neither type had a significant effect on metabolism. These studies fail to fully explain the mechanism by which yoga affects obesity due to differences in yoga styles and their lack of standardization, variations in practice durations, and the differing characteristics of study populations. Furthermore, studies on obesity and yoga often have short intervention durations (an average of 8 weeks), with most involving 60-90 minute sessions conducted 1-2 times per week. Since longer-term studies are needed to better understand the relationship between obesity and yoga, this study aims to investigate the effects of yoga exercises on body composition, respiratory parameters, functional level, sleep quality, quality of life, and emotional state in overweight and obese women.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

April 11, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

April 11, 2025

Last Update Submit

May 16, 2025

Conditions

Keywords

overweightobesityyogabody compositionpulmonary functionsdepressionanxiety

Outcome Measures

Primary Outcomes (15)

  • Forced Vital Capacity (FVC)

    Spirometry is a fundamental test for assessing lung function and is essential for the evaluation and monitoring of respiratory diseases. Spirometry is a physiological test that measures the maximum effort a person can exhale and the maximum volume of air they can exhale. For the evaluation of lung function, a Care Fusion brand spirometry device will be used. Before the test, the patient's gender, age, height, and weight will be recorded in the device. The patient will be seated in a position that facilitates the required maneuvers, and nasal breathing will be prevented by placing a nose clip. After three test measurements with 95% consistency, the best value obtained will be used.

    From enrollment to the end of treatment at twelve weeks

  • Assessment of Dynamic Balance and Functional Level (Timed Up and Go Test)

    The test, originally called the "Timed Up \& Go Test," is frequently used to measure the functional status of the lower extremities. This test also assesses individuals' ability to maintain balance during transfers and walking. In this test, individuals are asked to sit on a standard fourtyfive cm high chair with their feet flat on the ground, then stand up, walk as quickly but safely as possible for three meters, turn around at the marked point three meters away, walk back toward the chair, and sit down again. The time taken between starting and finishing the test is recorded in seconds using a stopwatch. Individuals are asked to repeat the test three times, and the average of the three trials is used for analysis.

    From enrollment to the end of treatment at twelve weeks"

  • Body Mass Index

    Weight (kg): The Tanita BIA scale device will measure the individual's body weight in kilograms. This measurement is essential for calculating other body composition parameters and assessing overall health. Height (cm): A stadiometer with an accuracy of ±0.5 cm will be used to measure the individual's height in centimeters. Accurate height measurement is fundamental for calculating body mass index (BMI) and assessing growth patterns.After completing the measurements, the dietitian will calculate the BMI by dividing weight in kilograms by the square of height in meters. BMI is a widely used indicator to assess whether an individual has a healthy body weight for a given height.

    From enrollment to the end of treatment at twelve weeks

  • Waist Circumference

    Waist circumference will be measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, using a non-stretch tape measure. The individual will stand with feet close together, arms at the sides, and body weight evenly distributed. The measurement will be taken at the end of a normal expiration, ensuring the tape is horizontal and snug but not compressing the skin.

    From enrollment to the end of treatment at twelve weeks

  • Hip Circumference

    Hip circumference will be measured around the widest portion of the buttocks, with the tape parallel to the floor. The individual will stand with feet close together, arms at the sides, and body weight evenly distributed. The measurement will be taken to the nearest 0.1 cm, ensuring the tape is snug but not compressing the skin.

    From enrollment to the end of treatment at twelve weeks

  • Forced Expiratory Volume at One Second (FEV1)

    Spirometry is a fundamental test for assessing lung function and is essential for the evaluation and monitoring of respiratory diseases. Spirometry is a physiological test that measures the maximum effort a person can exhale and the maximum volume of air they can exhale. For the evaluation of lung function, a Care Fusion brand spirometry device will be used. Before the test, the patient's gender, age, height, and weight will be recorded in the device. The patient will be seated in a position that facilitates the required maneuvers, and nasal breathing will be prevented by placing a nose clip. After three test measurements with 95% consistency, the best value obtained will be used.

    From enrollment to the end of treatment at twelve weeks

  • Peak Expiratory Flow (PEF)

    Spirometry is a fundamental test for assessing lung function and is essential for the evaluation and monitoring of respiratory diseases. Spirometry is a physiological test that measures the maximum effort a person can exhale and the maximum volume of air they can exhale. For the evaluation of lung function, a Care Fusion brand spirometry device will be used. Before the test, the patient's gender, age, height, and weight will be recorded in the device. The patient will be seated in a position that facilitates the required maneuvers, and nasal breathing will be prevented by placing a nose clip. After three test measurements with 95% consistency, the best value obtained will be used.

    From enrollment to the end of treatment at twelve weeks

  • Maximum Mid-expiratory Flow 25-75% (MMEF25-75)

    Spirometry is a fundamental test for assessing lung function and is essential for the evaluation and monitoring of respiratory diseases. Spirometry is a physiological test that measures the maximum effort a person can exhale and the maximum volume of air they can exhale. For the evaluation of lung function, a Care Fusion brand spirometry device will be used. Before the test, the patient's gender, age, height, and weight will be recorded in the device. The patient will be seated in a position that facilitates the required maneuvers, and nasal breathing will be prevented by placing a nose clip. After three test measurements with 95% consistency, the best value obtained will be used.

    From enrollment to the end of treatment at twelve weeks

  • FEV1/FVC

    Spirometry is a fundamental test for assessing lung function and is essential for the evaluation and monitoring of respiratory diseases. Spirometry is a physiological test that measures the maximum effort a person can exhale and the maximum volume of air they can exhale. For the evaluation of lung function, a Care Fusion brand spirometry device will be used. Before the test, the patient's gender, age, height, and weight will be recorded in the device. The patient will be seated in a position that facilitates the required maneuvers, and nasal breathing will be prevented by placing a nose clip. After three test measurements with 95% consistency, the best value obtained will be used.

    From enrollment to the end of treatment at twelve weeks

  • Weight (kg)

    Weight analysis will be conducted under the supervision of a dietitian using the Tanita bioelectrical impedance analysis (BIA) scale device to measure.

    From enrollment to the end of treatment at twelve weeks

  • Fat Percentage (%)

    Fat Percentage (%) analysis will be conducted under the supervision of a dietitian using the Tanita bioelectrical impedance analysis (BIA) scale device to measure.

    From enrollment to the end of treatment at twelve weeks

  • Height (cm)

    For height measurement (cm), a stadiometer (±0.5 cm) will be used.

    From enrollment to the end of treatment at twelve weeks

  • Fat Mass (kg)

    Fat Mass (kg) analysis will be conducted under the supervision of a dietitian using the Tanita bioelectrical impedance analysis (BIA) scale device to measure.

    From enrollment to the end of treatment at twelve weeks

  • Muscle Mass (kg)

    Muscle Mass (kg) analysis will be conducted under the supervision of a dietitian using the Tanita bioelectrical impedance analysis (BIA) scale device to measure.

    From enrollment to the end of treatment at twelve weeks

  • Muscle Percentage (%)

    Muscle percentage (%) analysis will be conducted under the supervision of a dietitian using the Tanita bioelectrical impedance analysis (BIA) scale device to measure.

    From enrollment to the end of treatment at twelve weeks

Secondary Outcomes (4)

  • Assessment of Quality of Life (Short Form-36)

    From enrollment to the end of treatment at twelve weeks"

  • Assessment of Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

    From enrollment to the end of treatment at twelve weeks"

  • Assessment of Emotional Status (Beck Depression Inventory (BDI))

    From enrollment to the end of treatment at twelve weeks"

  • Assessment of Emotional Status (Beck Anxiety Inventory (BAI))

    From enrollment to the end of treatment at twelve weeks"

Study Arms (2)

yoga exercise group

EXPERIMENTAL

The program will run for twelve weeks, with three sessions per week, each lasting sixty minutes, under the guidance of Physiotherapist Tuğçe BAĞCI.

Behavioral: yoga exercises

control group

NO INTERVENTION

Participants in this group will not receive any exercise intervention. They will be instructed not to participate in any exercise program throughout the duration of the study.

Interventions

yoga exercisesBEHAVIORAL

The yoga program, based on Hatha yoga content, will be conducted in groups of 10 participants, for 12 weeks, 3 days a week, at the same time each day (12:00-13:00), and will be administered by an experienced physiotherapist (Appendix 4). Before starting the training program, the exercise group will be given a one-week adaptation period, during which the exercises to be performed in three sessions per week will be taught. Participants in the exercise group who miss sessions for various reasons will be given an additional one-week period to make up for missed sessions. Participants who miss more than four sessions will be excluded from the study. Participants were informed in advance about any personal items they might need before each yoga session (such as towels, tissues, etc.) and were advised to bring their own. The yoga sessions were held in the sports hall of the Artvin Çoruh Dormitory, where the required equipment for yoga (e.g., mats, blocks) was provided. The yoga program was

yoga exercise group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWOMEN
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years
  • Body Mass Index (BMI) ≥ 25
  • Waist circumference \> 88 cm
  • Waist-to-hip ratio \> 0.8
  • Being literate, willing to participate, and signing the informed consent form
  • No mental disorders
  • No orthopedic or neurological conditions affecting balance
  • No history of surgical operations in the last 6 months

You may not qualify if:

  • Pregnant and breastfeeding mothers
  • Participants following any diet program for obesity
  • Individuals with syndromic or endocrine-related obesity
  • Participants who regularly exercise
  • Individuals using psychiatric medication
  • Participants with a medical history that would prevent them from practicing yoga
  • Participants with cardiovascular diseases that prevent exercise
  • Participants with a yoga history within the last 6 months
  • Individuals with any complications of obesity requiring medication, such as Type 2 diabetes or Stage 2 hypertension
  • Experiencing pain over 7 on the Visual Analog Scale (VAS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Ulusoy, M., Sahin, N. H., & Erkmen, H. (1998). Turkish version of the Beck Anxiety Inventory: psychometric properties. Journal of cognitive psychotherapy, 12(2), 163.

    BACKGROUND
  • Telles S, Sharma SK, Singh A, Kala N, Upadhyay V, Arya J, Balkrishna A. Quality of Life in Yoga Experienced and Yoga Naive Asian Indian Adults with Obesity. J Obes. 2019 Apr 30;2019:9895074. doi: 10.1155/2019/9895074. eCollection 2019.

    PMID: 31183215BACKGROUND
  • Shohani M, Badfar G, Nasirkandy MP, Kaikhavani S, Rahmati S, Modmeli Y, Soleymani A, Azami M. The Effect of Yoga on Stress, Anxiety, and Depression in Women. Int J Prev Med. 2018 Feb 21;9:21. doi: 10.4103/ijpvm.IJPVM_242_16. eCollection 2018.

    PMID: 29541436BACKGROUND
  • Panwar, S. H. E. E. T. A. L., Chourishi, A. S. H. U. T. O. S. H., & Makwana, J. A. Y. A. N. T. (2012). Effect of pranayama (yoga) on pulmonary function test of young healthy students. Int J Pharma Bio Sci, 3(4), 12-6.

    BACKGROUND
  • Kargün, M., Togo, O. T., Biner, M., & Pala, A. (2016). Üniversite öğrencilerinin fiziksel aktivite düzeylerinin incelenmesi. Marmara Üniversitesi Spor Bilimleri Dergisi, 1(1), 61-72.

    BACKGROUND
  • Hisli, N. (1989). Beck depresyon envanterinin universite ogrencileri icin gecerliligi, guvenilirligi.(A reliability and validity study of Beck Depression Inventory in a university student sample). J. Psychol., 7, 3-13.

    BACKGROUND
  • Gündede, E. (2018). Serebral palsili çocukların fonksiyonelliği ile ebeveynlerinin bakım yükü, aktivite düzeyi, yaşam kalitesi ve psikolojik durumu arasındaki ilişki. Okan Üniversitesi, İstanbul.

    BACKGROUND
  • Cramer H, Thoms MS, Anheyer D, Lauche R, Dobos G. Yoga in Women With Abdominal Obesityߞa Randomized Controlled Trial. Dtsch Arztebl Int. 2016 Sep 30;113(39):645-652. doi: 10.3238/arztebl.2016.0645.

    PMID: 27776622BACKGROUND
  • Asiah ASS, Norhayati MN, Muhammad J, Muhamad R. Effect of yoga on anthropometry, quality of life, and lipid profile in patients with obesity and central obesity: A systematic review and meta-analysis. Complement Ther Med. 2023 Sep;76:102959. doi: 10.1016/j.ctim.2023.102959. Epub 2023 Jun 24.

    PMID: 37356673BACKGROUND

MeSH Terms

Conditions

OverweightObesityDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 11, 2025

First Posted

May 20, 2025

Study Start

June 1, 2025

Primary Completion

August 15, 2025

Study Completion

October 1, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05