UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046017 |
|---|---|
| Receipt number | R000052528 |
| Scientific Title | WOMEN health, exercise, telerehabilitation |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2021/11/09 18:02:02 |
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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 | Obstetrics 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
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
acarmanolya@hotmail.com
Sponsor or person
Institute
Baskent university
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
