UMIN-CTR Clinical Trial

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