1. Objectives: Effects of Aerobic and Resistance Exercise Program on Physical_Psychological Adaptation in the elderly patients with Heart Failure.
2. Design: A randomized, clinical trial design. The study population is the male elderlies with heart failure (type 2&3). Sample size: 60 Patients in experimental and control groups (30 patients in the group). Sampling is consecutive that will be randomized to an experimental or a control group by blocking method. Study Field: Echocardiography unit and exercise hallway located at Ramsar Imam Sadjad hospital. Methods: It will be used of a 3-dimentional Questionnaire consisted of; demographic variables, Psychological health Questionnaire of patients with heart failure and 6-Minute Walk Test (MWT) for measuring psychological and physical adaptation.
3.Participants: The male elderly patients with CHF must be at least 60 years of age and 74years maximum; the participants with history minimum of 6 months. Exclusion criteria: Patients with a history of Coronary Artery Disease on cardiac angiogram of >70%, sustained ventricular arrhythmias, and HR >120 bpm.
4. Interventions: Experimental group; It will do the aerobic exercise (slow walking) at the 12 weeks, 3 times per week within 30 minutes. After the end of 4 weeks, Light Resistance exercise program (using Dumbbell 500gr; within 30 minutes, 3 times per week) will do until the end of week 12.
The control group: Participants in the control group will not receive any exercise intervention.
5. The main outcome variables: The primary outcome; improved physical and psychological adaptation. The secondary outcome; improved quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111630930N1
Registration date:2017-06-02, 1396/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-02, 1396/03/12
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, 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 Physical_Psychological Adaptation in the Male elderly patients with Heart Failure
Public title
The effect of exercise on Physical_Psychological Adaptation in the Male elderly patients with Heart Failure
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The elderly patients with Heart Failure must be at least 60 years of age and 74years maximum; diagnosed with systolic heart failure with an ejection fraction of less than or equal to 40%, confirmed by echocardiogram and have approval from the primary cardiologist; participants with history minimum of 6 month; ability to Persian language speaking and comprehension.
Exclusion criteria: History of coronary artery disease with the stenosis of >70% on cardiac angiogram; sustained ventricular arrhythmias requiring anti-arrhythmic medications; 2nd or 3rd-degree heart block, and HR >120 bpm; the patients with neurologic or orthopedic conditions that limits their 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
47176-47745
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 Physical adaptation
Timepoint
before and after intervention at the end of week 12
Method of measurement
Questionnaire consisted of demographic variables, Questionnaire Psychological adaptation of cardiac disease, 6 Minute Walk test (MWT)
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group: Implementation of exercise interventions in the experimental group; the patients will do slow walking (light aerobic exercises) in the 12 weeks, 3 times per week within 30 minutes. In addition, participants in the intervention group will be instructed; "Before and after exercise do heating and cooling exercises for 5 to 10 minutes." They should walk for 30-minute after the warm-up exercise. After 4 weeks, in addition to walking, light resistance exercise program (using Dumbbell 500gr; 3 times per week, within 30 minutes) will be implemented until the end of the week 12.
Category
Lifestyle
2
Description
2. Control group: The control group will not receive any interventions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ramsar Imam Sadjad hospital
Full name of responsible person
Ali Pourhabib
Street address
Enghelab Square
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
Babol University of Medical Sciences
Full name of responsible person
Ali Pourhabib
Position
MSc Student in Geriatric Nursing
Other areas of specialty/work
Street address
Nursing Department of Ramsar, Imam Sadjad hospital, Enghelab Square