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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000046616
Receipt No. R000053179
Scientific Title The Effects of Clinical Pilates Exercises via Telerehabilitation on Menopausal Symptoms, Quality of Life, Depression and Anxiety in Postmenopausal Women During the COVID-19 Isolation Period
Date of disclosure of the study information 2022/01/13
Last modified on 2022/01/12

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Basic information
Public title The Effects of Clinical Pilates Exercises via Telerehabilitation on Menopausal Symptoms, Quality of Life, Depression and Anxiety in Postmenopausal Women During the COVID-19 Isolation Period
Acronym The Effects of Clinical Pilates Exercises via Telerehabilitation in Postmenopausal Women
Scientific Title The Effects of Clinical Pilates Exercises via Telerehabilitation on Menopausal Symptoms, Quality of Life, Depression and Anxiety in Postmenopausal Women During the COVID-19 Isolation Period
Scientific Title:Acronym The Effects of Clinical Pilates Exercises via Telerehabilitation in Postmenopausal Women
Region
Asia(except Japan)

Condition
Condition almost done
Classification by specialty
Obsterics and gynecology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 the effect of exercise training with a telerehabilitation method on menopausal symptoms, life quality, depression and anxiety levels in postmenopausal women
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes quality of life
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 tele-pilates group
Interventions/Control_2 no tele-pilates group
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
45 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria being in the first 5 years of the postmenopausal period,
- being in the age range of 45-60,
- having physical or perceptive competence for exercise,
- not having any pathology or deformity on the spine,
- volunteering to participate in the study,
- at least 12 months of not having menstruation and being in the period of hormonal, surgical or natural menopause.
Key exclusion criteria having severe heart disease (aortic stenosis, angina, hypertrophic cardiac myopathy, arrhythmia, pacemaker),
- getting hormone therapy,
- having systemic diseases such as high blood pressure and diabetes,
- having psychiatric diseases,
- having musculoskeletal system diseases that may prevent exercising,
- having balance and coordination problems.

Target sample size 40

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 baskentuniversity
Institute
Department

Funding Source
Organization baskentuniversity
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

Other administrative information
Date of disclosure of the study information
2022 Year 01 Month 13 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 40
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
2020 Year 06 Month 20 Day
Date of IRB
2020 Year 07 Month 01 Day
Anticipated trial start date
2020 Year 07 Month 02 Day
Last follow-up date
2021 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 12 Day
Last modified on
2022 Year 01 Month 12 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053179

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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