This study is a quasi- experimental and double -blind study. Goal of study: to determine the effect of aerobic exercise on the quality & quantity of sleep and metabolic profile in elderly referring to health care of lar.
Sampling methods: sampling (60 elderly)will randomly assign to two group: case & control with the blocking method. After obtaining informal consent, questionnaires completed by researcher before intervention. blood test for metabolic profile was done.
Inclusion criteria are willingness to participate in the study and fluent in speaking and understanding Persian, age between 60-75 years without CVD &unstable angina physical defects & sever osteoporosis that limit aerobic exercise. being with cognitive or psychological abnormalities, lack of regular exercise, Not participate in the same study.
exclusion criteria are not participating more than two sessions in exercise program. no willingness to cooperate. leg fracture & hospitalization. eating lipid lowering & hypnotic drugs. weakness of the extremities
Each group will followed for 12 weeks. for case group, exercise program third a week for 1 hour each time done. exercise program is combines walking, stretching and swimming in the warm water.
control group had only activity daily living was done.
After 12 weeks the PSQI & quality question & blood test for lipid profile 48 hour after exercise program was done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201304102812N14
Registration date:2013-12-04, 1392/09/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-12-04, 1392/09/13
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-02-19, 1391/12/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic exercise on the quality & quantity of sleep and metabolic profile in elderly referring to health care center of lar:2013
Public title
Effect of aerobic exercise on blood lipid level &sleep in older adult people
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Willingness to participate in the study and fluent in speaking and understanding Persian, age between 60-75 years without CVD & unstable angina physical defects & sever osteoporosis that limited aerobic exercise. being with cognitive or psychological abnormalities, lack of regular exercise, Not participate in the same study.
Exclusion criteria:Don't participate more than two sessions in exercise program. no willingness to cooperate. leg fracture &hospitalization. consumption lipid lowering & hypnotic drugs. weakness of the extremities
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University Of Medical Sciences, Zand Boulevard
City
Shiraz
Postal code
14336-71348
Approval date
2013-11-05, 1392/08/14
Ethics committee reference number
92/280280
Health conditions studied
1
Description of health condition studied
quality & quantity sleep
ICD-10 code
G47
ICD-10 code description
(Disorder of initiating and maintaining sleep ( insomnia
2
Description of health condition studied
metabolic profile
ICD-10 code
E78
ICD-10 code description
Disorder of lipoprotein metabolis and other lipidaemias
Primary outcomes
1
Description
Metabolic profile
Timepoint
Before interventions, after the end of intervention
Method of measurement
blood test for T.C, HDL, LDL,TG
2
Description
Sleep Quantity
Timepoint
Before interventions, after the end of intervention
Method of measurement
Pitsburg (PSQI)questioner
3
Description
Sleep Quality
Timepoint
Before interventions, after the end of intervention
Method of measurement
Pitsburg (PSQI)questioner
Secondary outcomes
empty
Intervention groups
1
Description
Case group:For this group,exercise program three days in week, each time an 1hour for12 weeks was done. Exercise program combines walking, streaching and swimming in the warm water(after 9sessionof program aerobic exercise we have a session for swimming .
Category
Prevention
2
Description
Group control only have normal daily activities.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Rezea Hospital
Full name of responsible person
Dr Ahmad Amanat
Street address
Emam Reza Hospita, Dr Dadman Highway, New city, Larl
City
Lar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Vice Chancellr For Research Affairs, Shiraz University Of Medical Sciences, Zand Boulevard, Shiraz, Iran
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University Of Medical Sciences
Full name of responsible person
Maryam Seddigh
Position
Geriatric Nursing Graduate Student
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Hazrat Fatemeh, Namazi Square, Shiraz, Iran
City
Shiraz
Postal code
7193613119
Phone
+98 71164745458
Fax
Email
seddigh.maryam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Farkhondeh Sharif
Position
Professor
Other areas of specialty/work
Street address
School Of Nursing and Midwifery, Hazrat Fatemeh, Namazi Square, Shiraz, Iran
City
Shiraz
Postal code
1311971936
Phone
+98 71 1647 4251
Fax
Email
fsharif@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)