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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000046017
Receipt No. R000052528
Scientific Title WOMEN health, exercise, telerehabilitation
Date of disclosure of the study information 2021/11/09
Last modified on 2021/11/09

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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052528

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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