Protocol summary

Study aim
The effect of a six-week training program with corrective exercises on improving the health status and quality of life of the elderly
Design
This study is a randomized controlled trial with pretest-posttest designs. The subjects will be selected based on simple random sampling and randomly assigned to two intervention (15 people) and control (15 people) groups.
Settings and conduct
The pre-test session will be held one week before the start of the training program. Subjects will complete a quality of life questionnaire and the status of the foot, static balance, body composition, abnormalities, muscle strength and maximal oxygen consumption of them will be examined. Based on the pre-test results, the designed health booklet will be given to anyone. After the 6-week training period, the post-test will be conducted and the results will be compared with the pre-test to determine the effect of the intervention on the health status and quality of life of the elderly.
Participants/Inclusion and exclusion criteria
1) age range of 60 to 75 years; 2) residence in Tehran; and possibility to visit Firoozgar Hospital in Tehran at the time and place specified by the center; 3) ability to perform physical activity; 4) lack of drug use; 5) lack of Dementia, 6) the absence of neurological, respiratory, metabolic and musculoskeletal disorders, 7) the absence of chronic unstable diseases, such as diabetes and malignancies, 8) the absence of severe congenital defects, 9) lack of serious visual or auditory disorders
Intervention groups
The training program including corrective exercises, balance, aerobic and resistance training
Main outcome variables
Health Promotion and improving the quality of life of the elderly

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190306042945N1
Registration date: 2019-04-12, 1398/01/23
Registration timing: registered_while_recruiting

Last update: 2019-04-12, 1398/01/23
Update count: 0
Registration date
2019-04-12, 1398/01/23
Registrant information
Name
Bijan Forogh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1612
Email address
forogh.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-12, 1397/12/21
Expected recruitment end date
2020-04-09, 1399/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of corrective exercises on improving the quality of life in the elderly
Public title
The effect of corrective exercises on improving the quality of life in the elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 60 to 75 years. Accommodation in Tehran and the possibility to visit the Firoozgar Hospital in Tehran in the date and time specified by the Center. Ability to perform physical activity
Exclusion criteria:
Drug use Dementia The presence of neurological, respiratory, metabolic and musculoskeletal disorders chronic unstable diseases such as diabetes and malignancies Severe congenital defects Serious visual or auditory disorder
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random number table Unit of Randomization: Individual
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Next to the Milad tower, Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.420

Health conditions studied

1

Description of health condition studied
Physical disability in elderly
ICD-10 code
Z86.5
ICD-10 code description
Personal history of mental and behavioral disorders

Primary outcomes

1

Description
Change in the individual's score in quality of life questionnaire
Timepoint
At the beginning of the study and after the completion of the six-month training program
Method of measurement
Quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training program including corrective exercises, balance aerobic and resistance training
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Bijan Forogh
Street address
Beh Afarin St., Karim Khan St., Valiasr Square
City
Tehran
Province
Tehran
Postal code
۱۵۹۳۷۴۷۸۱۱
Phone
+98 21 8214 1612
Email
bijanfr@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakouti
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Bijan Forogh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Firoozgar Hospital, Behafarin Avenue, 1617763141, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1612
Fax
Email
forogh.b@iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information is available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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