UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046616 |
|---|---|
| Receipt number | 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 20:38:54 |
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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
| Obstetrics 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
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
baskentuniversity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053179
