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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05657600
Other study ID # IstanbulGalataU
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2020
Est. completion date September 15, 2022

Study information

Verified date December 2022
Source Istanbul Galata University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study aiming to Examine the effects of video-based yoga compared to face-to-face yoga and physical exercise practices on the physical features, respiratory capacity and sleep quality of sedentary women in pandemic days. The pranayama (respiration), asana (poses), and meditation were given to the face-to-face yoga group, and the same exercises of the face-to-face yoga group were recorded in the video for the video-based yoga group. The exercises for respiration, muscle strengthening, stabilization, and flexibility were given face-to-face to the physical exercise group.


Description:

This is an observational study aiming to Examine the effects of video-based yoga compared to face-to-face yoga and physical exercise practices on the physical features, respiratory capacity and sleep quality of sedentary women in pandemic days. The respiration, poses, and meditation were given to the face-to-face yoga group, and the same exercises of the face-to-face yoga group were recorded in the video for the video-based yoga group. The exercises for respiration, muscle strengthening, stabilization, and flexibility were given face-to-face to the physical exercise group. The sessions for each group were given for a total of 6 weeks (2days/week) as 12 sessions, and 60 min. Their respiration (spirometer Pony-Fx), sleep (Pittsburgh Sleep Quality Index), posture (New York Posture Rating Chart), balance (Single Leg Stance Assessment, Functional Reach Distance), functional strength (5X Sit-to-Stand test), fatigue (Fatigue Severity Scale) and quality of life (WHOQOL-BREF) were evaluated at the beginning and end of the 6 weeks. The data were assessed statistically.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date September 15, 2022
Est. primary completion date May 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - being between the age of 18 - 60 years, - not having any history of a systemic disease, such as musculoskeletal or neurological problems, cardiac or lung diseases, diabetes and no history of recent surgery - not having participated in a regular exercise program in the last 6 months and - not having a history of active sports engagement Exclusion Criteria: - not being voluntary to join the study and - missing more than three sessions during the study period

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sociodemographic profile, quality of life, sleep, fatigue, physical function and balance assessments
Respiratory functions are assessed with a portable spirometer according to the criteria of the American Thoracic Society and European Respiratory Society. Measures the physical, mental, social, and environmental well-being were tested to understand the quality of life. The quality of sleep, delayed sleep, sleep disorders, usage of sleeping pills, and loss of functionality during the day were assessed. The balance and static standing capability of the participants were tested. The functional reach of participants were tested by expecting them to lean forwardly as far as they can without taking a step, nor rising their heels. The fatigue feeling of the participants as everyday life were assessed. The posture of the participants was assessed on 13 regions at anterior, posterior and lateral views.
Other:
Video-based yoga
Video-based yoga
Face-to-face yoga
Face-to-face yoga
physical exercise
physical exercise

Locations

Country Name City State
Turkey Kadikoy Municipality Rasimpasa Volunteer Training and Consultation Centre Istanbul Kadikoy

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Galata University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other 5X Sit-to-Stand test It is a test to evaluate the functional strength of the lower extremities. The participants were asked to cross the arms on their chest while sitting on the chair and then stand up and sit on a chair as quickly and without stopping as possible, the elapsed time (minutes) at the end of the fifth repetition was recorded. 2 months
Other The Single-Leg Stance Test It is a test to evaluate the balance and static standing capability of the participants. The participant was asked to lift one foot, while standing. The time ( minutes) was stopped, once the foot touch the floor 2 months
Other The Functional Reach test It is a test to assess the functional reach of the participants. They were asked to stand by the wall at their dominant side with 90-degree shoulder flexion, 180-degree elbow extension, and with a closed fist; keep their feet apart from each other at their hip-width. The level of the head of the 3rd metacarpal bone was marked over the ruler horizontally attached to the wallis marked. Then, the participant was asked to "lean forwardly as far as they can without taking a step, nor rising their heels". The place where the 3rd metacarpal head of the participants reached was marked again. After three trials the amount of reaching (cm) that was the distance between the initial and the final mark was measured and the average was recorded. 2 months
Other Fatigue Severity Scale It was used to measure the fatigue feeling of the participants as everyday life. Each item of the scale was comprised of 7 scorings with 9 items in total. The arithmetic average of the total score was taken. Cases with a score of 4 and above were considered in the fatigue group. 2 months
Other New York Posture Assessment Test It is used to assess the posture from anterior, posterior and lateral sides as A-head, B- shoulder levels, C- spine, D- hip levels, E- feet; and mediolaterally, F-feet arches; and at posterior side: G- head, H-chest, I-shoulders, J- upper, K- trunk, L- abdomen, M- low back. They were scored as (5) for good-normal, (3) for moderately affected, (1) severely affected postures. The score is between 65-13 with the cut-off score = 45 is very good, 44-40 is good, 39-30 is moderate, 29-20 is poor, = 19 is bad posture. 2 months
Other The World Health Organization Quality of Life-BREFF The questionnaire assessing the quality of life of the participants consists of 26 questions and measures of physical, mental, social, and environmental well-being adult population were assessed. The Turkish version has 27 questions the 27th was named the Environment-Turkish. The area scores are calculated between 1 and 100. As the scores increase, the quality of life increases as well.
It is a self-reporting scale that is comprised of 19 items. Each element of the scale is evaluated on a score of 0 to 3 equally. Questions are assigned a score between 0 and 3 and higher scores reflect bad sleep quality.The total PSQI score of 0-21 is acquired after the addition of the sub scales. High values indicate bad sleep quality and a higher level of sleep disturbance. A total score above 5 indicates that the quality of sleep is poor clinically.
2 months
Primary Respiratory Function Tests Respiratory Function (portable spirometer; Pony Fx, Rome, Italy) assessed according to the criteria of the American Thoracic Society and European Respiratory Society. The deep expiration after maximal inspiration aForced Vital capacity-FVC(lts), the air volume released in the first second during forced expiration - Forced Expiratory Volume 1-FEV1(lts), the ratio of forced expiratory volume to the forced vital capacity in the first second - FEV1/FVC (%), peak expiratory flow during forced expiration - PEF (lt/sec) and vital capacity - VC (lts) are evaluated. 2 months
Primary The demographic data of the participants The demographic data of the participants as gender, age, dominant hand, educational background, smoking status, and the number of cigarettes per day were recorded by means of a specially prepared questionnaire for this study. 2 months
Primary body weight, height and body mass index of the participants The body weight (kilograms), height (meters) will be measured and the body mass index (kg/m2) of each participant will be recorded. 3 months
Secondary Pittsburgh Sleep Quality Index-PSQI It is a self-reporting scale that is comprised of 19 items. Each element of the scale is evaluated on a score of 0 to 3 equally. Questions are assigned a score between 0 and 3 and higher scores reflect bad sleep quality.The total PSQI score (0-21) as scale is acquired after the addition of the sub scales in the questionnaire. High values indicate bad sleep quality and a higher level of sleep disturbance. A total score above 5 indicates that the quality of sleep is poor clinically. 2 months
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