(1) Objectives:
“Effects of aerobic and resistance exercise program on sleep quality in the elderly male patients with heart failure”.
(2) Design:
This study is a true-experimental, clinical trial design that population is the male elderlies with CHF (type 2&3). Sample size is 60 Patients in interventional and control groups (30 patients in one group). Sampling method is consecutive that will be randomized to an experimental (intervention) group or a wait-list control group by blocking method. Field of study was Echocardiography unit and exercise hall of Ramsar Imam Sadjad hospital.
(3) Setting and conduct:
In order to collect data will be used of Questionnaire consisted of demographic variables and sleep quality questionnaire. Sleep quality questionnaire will be completed in before and after intervention and will be compared.
(4) Participants including major eligibility criteria:
Male Participants must be at least 60 years of age and 74 years maximum with history minimum of 6 month.
Exclusion criteria:
A history of coronary artery disease on cardiac angiogram of > 70% ؛sustained ventricular arrhythmias؛ Heart Rate >120 bpm
(5): ) Intervention:
The experimental group received the intervention 4 week ؛3 times in week for 30 minute combined aerobic and resistance training exercise program).
In intervention group patients received the Aerobic and resistance exercises program in 3 months, 3 times in week.
the wait-list control group:
received usual care for heart failure patients.
(6) Main outcome measures:
The primary outcome improved quality of sleep
Secondary outcomes improve quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120430930N2
Registration date:2017-05-27, 1396/03/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-27, 1396/03/06
Registrant information
Name
Ali پورحبيب
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 5151
Email address
a.pourhabib@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Babol University of Medical Sciences.
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2016-12-15, 1395/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of aerobic and resistance exercise program on sleep quality in the elderly patients with heart failure
Public title
The effect of exercise on sleep of elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Participants male must be at least 60 years of age and 74 years maximum diagnosed with systolic heart failure with an ejection fraction of less than or equal to 40% confirmed by echocardiogram cardiologists Imam Sadjad was stablished in Ramsar؛ participants with history minimum of 6 month؛ ability to Persian language speaking and comprehension.
Exclusion criteria:
A history of coronary artery disease on cardiac angiogram of > 70% physically limiting angina usual daily activity؛ sustained ventricular arrhythmias requiring antiarrhythmic medications , 2nd or 3rd degree heart block؛ Heat Rate >120 bpm, neurologic or orthopedic condition that limits physical ability to exercise.
Age
From 60 years old to 74 years old
Gender
Male
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
Randomized trial by blocking method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Postal code
4717647745
Approval date
2016-10-31, 1395/08/10
Ethics committee reference number
MUBABOL.REC.1395.166
Health conditions studied
1
Description of health condition studied
Congestive heart failure
ICD-10 code
I50.0
ICD-10 code description
Congestive heart failure
Primary outcomes
1
Description
Improve sleep quality
Timepoint
before and after intervention at the end of week 12
Method of measurement
Questionnaire consisted of demographic variables؛ sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
1. Intervention group:
The experimental group received the intervention (12-week combined aerobic and resistance training exercise program). In intervention group patients received the Aerobic and resistance exercises program in 3 months, 3 times in week.
Category
Lifestyle
2
Description
2. Control group:
The wait-list control group with no intervention does not take place.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ramsar Imam Sadjad hospital
Full name of responsible person
Zahra Fotoukian
Street address
Infront of the Post office - Mottahari street
City
Ramsar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Babol University of Medical Sciences Babol University
Full name of responsible person
Doctor Ali Akbar Moghadamnia
Street address
Babol University of Medical Sciences, Ganjafrooz Street , Babol , Mazandaran
City
Babol
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 Babol University of Medical Sciences Babol University
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
Assistant Professor, Department of Nursing, Ramsar Nursing and Midwifery School, Babol University of
Full name of responsible person
Zahra Fotoukian
Position
Phd. Nurssing
Other areas of specialty/work
Street address
Ramsar- Motahari Street- Nursing and Midwifery School
City
Ramsar
Postal code
4691714141
Phone
+98 11 5522 5151
Fax
Email
Z.Fotoukian@mubabol.ac.ir zfotoukian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Assistant Professor, Department of Nursing, Ramsar Nursing and Midwifery School, Babol University of
Full name of responsible person
Zahra Fotoukin
Position
Phd. Nurssing
Other areas of specialty/work
Street address
Ramsar- Motahari street- Nursing and Midwifery School
City
Ramsar
Postal code
4691714141
Phone
+98 11 5522 5151
Fax
Email
Z.Fotoulian@mubabol.ac.ir zfotoukian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Assistant Professor, Department of Nursing, Ramsar Nursing and Midwifery School, Babol University of
Full name of responsible person
Zahra Fotoukian
Position
phd . Nursing
Other areas of specialty/work
Street address
Mottahari ST- Ramsar Nursing and Midwifery School,
City
Ramsar
Postal code
4691714141
Phone
+98 11 5525 5151
Fax
Email
Z.fotoukian@mubabol.ac.ir zfotoukian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)