UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Tele-Yoga Training in Healthy Women on Menstrual Symptoms, Quality of Life, Anxiety-Depression Level, Body Awareness and Self-Esteem during Covid-19 pandemic.
Acronym	The effectiveness of Tele-yoga
Scientific Title	WOMEN health, exercise, telerehabilitation
Scientific Title:Acronym	rehabilitation
Region	Asia(except Japan)

Condition
Condition	research article
Classification by specialty	Medicine in general Obsterics and gynecology Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study was planned to examine the effects of tele-yoga training on menstrual symptoms, quality of life, anxiety-depression level, body awareness and self-esteem in healthy women.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Phase II,III

Assessment
Primary outcomes	quality of life by Nottingham health profile (NHP)
Key secondary outcomes	Menstrual Symptom Scale (MSS), depression levels by Beck depression scale (BDS), anxiety levels by State and trait anxiety scale (STAI), body awareness by body awareness questionnaire (BAQ) and self-esteem by Rosenberg self-esteem scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	tele-yoga training
Interventions/Control_2	no treatment
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	45 years-old >=
Gender	Female
Key inclusion criteria	Healthy women without any spinal disease or deformity with ongoing menstrual cycle, between the ages of 18 and 45, who did not take any medication and mineral supplements during the last three menstrual cycles, were physically or perceptually competent to exercise, has never done yoga before were included in this study.
Key exclusion criteria	Women with musculoskeletal system, neurological, severe cardiopulmonary, chronic systemic, psychiatric, balance and coordination problems, vestibular system disease, pregnancy history that may prevent exercise and women taking hormone replacement therapy were not included in this study.
Target sample size	16

Research contact person
Name of lead principal investigator	1st name manolya Middle name Last name acar
Organization	Baskent University
Division name	Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences
Zip code	06790
Address	Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Baskent University, Ankara, Turkey.
TEL	+9005392699266
Email	acarmanolya@hotmail.com

Public contact
Name of contact person	1st name manolya Middle name Last name acar
Organization	Baskent university
Division name	Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences,
Zip code	06790
Address	Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences, Baskent University, A
TEL	+9005392699266
Homepage URL
Email	acarmanolya@hotmail.com

Sponsor
Institute	Baskent university
Institute
Department

Funding Source
Organization	Baskent University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	bASKENT university
Address	Department of Physical Therapy and Rehabilitation, Faculty of Health Sciences,
Tel	+9005392699266
Email	acarmanolya@hotmail.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	Baskent UNIVERSITY

Other administrative information
Date of disclosure of the study information	2021 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	32
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 03 Month 18 Day
Date of IRB	2021 Year 03 Month 16 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2021 Year 07 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 09 Day
Last modified on	2021 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052528