Protocol summary

Summary
Purpose of study is determine the effect of Tai chi exercise on health level among elderly men who are the member of Pakdasht retirees club. Experimental clinical trial, two group (Intervention and Control). One hundred thirty two elderly men are divided randomly into 2 group (intervention and control). Sixty six persons are in intervention group and 66 persons in control group. Intervention consists practice Tai Chi exercise; 8 weeks; 3 times a week; 45-60 minutes. Control group: No intervention is done. Questioners are completed, four weeks after the intervention and eight weeks

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201703267529N12
Registration date: 2017-03-28, 1396/01/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-28, 1396/01/08
Registrant information
Name
Nahid Rejeh
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 3071
Email address
reje@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Shahed University
Expected recruitment start date
2017-03-14, 1395/12/24
Expected recruitment end date
2017-06-14, 1396/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of Tai Chi on the health of the elderly men
Public title
The impact of Tai Chi on the health of the elderly
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients’ willingness to participate in this study; Age over 60; Absence of sensory and motor disabilities; Cognition health(according to Abbreviate Mental test: score above 7); Ability to speak and understand Persian; Recently no Tai chi exercise; Not taking anti -anxiety and depression drugs; Geriatric depression scale score above 8; 6-Minute Walk test; having no drug addiction and alcohol; having no history of mental illness in the last month and sedative use Exclusion criteria: patient’s unwillingness to continue the collaboration in this study; absenteeism for more than two sessions; appearance of pain or other physical or mental problems that prevent the intervention; Older adults’ death.
Age
From 60 years old to 139 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Supportive care

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran.
City
Tehran
Postal code
Approval date
2017-02-11, 1395/11/23
Ethics committee reference number
IR.Shahed.REC.1395.1

Health conditions studied

1

Description of health condition studied
Elderly
ICD-10 code
R54
ICD-10 code description
Senility

Primary outcomes

1

Description
Happiness
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
Oxford Happiness Scale

2

Description
quality of life
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
LEIPAD quality of life questionnaire

Secondary outcomes

1

Description
Depression
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
GDS questionnaire

2

Description
Blood level of glucose
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
Blood glucose measurement (glucometry)

3

Description
Blood pressure
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
checklist

4

Description
Respiratory rate
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
checklist

5

Description
Pulse rate
Timepoint
Prior to the intervention, four weeks after the intervention and a eight weeks
Method of measurement
checklist

Intervention groups

1

Description
Intervention group: practice of short forms exercise of Tai Chi, 8 weeks, 3 times in week, 45-60 minutes.
Category
Lifestyle

2

Description
Control group: No intervention is done.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
retirement center in pakdasht
Full name of responsible person
Alireza Tajik Ghalae
Street address
City
Varamine

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University Vice chancellor for research
Full name of responsible person
Dr. Zahra Kiasalari
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University Vice chancellor for research
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
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran.
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Dr. Nahid Rejeh
Position
Associate Professor
Other areas of specialty/work
Street address
Shahed University, Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Express way, Tehran
City
Tehran
Postal code
Phone
+98 21 5121 3071
Fax
Email
nrejeh@yahoo.com
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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