Protocol summary

Summary
This study is a quasi-experimental of clinical trial; reasercher among the samples who have Inclusions criteria like:primary hypertension؛ Lack of cognitive disorders with AMT scale؛ Lack of depression or anxiety disorder according to the patient or medical records؛ No addiction؛ Not use of sedative drugs؛ Not doing meditation methods or tai chi will start her sampling.Statistical population includes 38 elderly women with hypertension that living in elderly care center in Tehran under the supervision of Behzisty center. method of sampling is available and targeted and Samples will be divided in to controls and intervention. assign of study groups are parallel and randomization method is close packet. then demographic characteristics and perceived stress as a form of pre-test 1 hour before intervention will be completed. interventional group have 6 weeks eight form of tai chi. Exclusions criteria are Lack of cooperation or Death of elder person؛ Not participating in more than 3 sessions of tai chi classes؛ having a orthostatic hypotension؛ heart attacks and stroke. duration of the intervention is three sessions of 40 to 60 minutes of Tai Chi which will be done by reasercher. Perceived stress as a post-test questionnaire will be completed one day after the treatment. The control group will not receive any special intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015072923408N1
Registration date: 2016-02-20, 1394/12/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Elnaz Talebi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7759 0500
Email address
talebi.e@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Tai Chi exercise on perceived stress of older women with hypertension
Public title
Effect of Tai Chi exercise on perceived stress of older women with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:primary hypertension؛ Lack of cognitive disorders with AMT scale؛ Lack of depression or anxiety disorder according to the patient or medical records؛ No addiction؛ Not use of sedative drugs؛ Not doing meditation methods or tai chi Exclusion criteria:Lack of cooperation or Death of elder person؛ No participating in more than 3 sessions of tai chi classes؛ having a orthostatic hypotension؛ heart attacks and stroke.
Age
From 60 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization method is close packet.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, between the intersection of Chamran and Sheikh faz o lah, Hemat highway, Tehran
City
Tehran
Postal code
Approval date
2015-08-05, 1394/05/14
Ethics committee reference number
IR.IUMS.REC.1394 . 9311580007

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Percieved stress
Timepoint
before intervention and 6 week after intervention
Method of measurement
Questionnaire of Percieved stress

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
Interventional group: have 6 weeks of Eight forms of Tai Chi after pre-test. Duration of intervention is three sessions of 40 to 60 minutes of Tai Chi which will be done by reasercher.Perceived stress as a post-test questionnaire will be completed one day after the treatment.
Category
Other

2

Description
control group : 38 elderly weman with hypertention that just do pre-test and do not get any intervention؛ after 6 weeks they will do post-test of Perceived Stress scale .
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arad nursing home center
Full name of responsible person
Doctor Fariba Derakhshannia؛manager
Street address
Arad nursing home center,Bazdar street,Farmaniyeh square, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Doctor Morteza Naserbakht
Street address
Iran University of Medical Science, 5 Floors, beetwen intersection of Chamran and Sheikh faz o lah, Hemat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery Iran
Full name of responsible person
Farideh bastani
Position
PHD in education and health promotion
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
bastani.f@iums.ac.ir؛ faridehbastani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
school of nursing and midwifery
Full name of responsible person
Farideh Bastani
Position
PHD in education and health promotion
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
Email
bastani.f@iums.ac.ir؛ faridehbastani@yahoo.com
Web page address
fnm.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
school of nursing and midwifery
Full name of responsible person
Farideh Bastani
Position
PHD in education and health promotion
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Rasheed Yassami street, Vali Asr street, Tehran
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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