Protocol summary

Summary
In this clinical trial study, 60 patients with heart failure who are referred to cardiac rehabilitation centers are randomly placed to the intervention group (n = 30) and control (n = 30) . After permission from the Ethics Committee and registered in the Ministry of Health clinical trial site, the study begins. All patients voluntarily provide written informed consent and they will assure that their information would remain confidential and they would have the authority to opt out from the experiment at any stage of the research. In the intervention group exercise 3 times a week for 8 weeks (maximum of 40 minutes per session) will be done. Each session includes 5-10 minutes warm-up, 20-40 minutes supervised training phase and 5-10 minutes of cooling and relaxing will be. During the supervised training phase, patients will exercise on a treadmill, stationary cycling and rowing Ergometer under Remote Monitoring, and will be done by trained personnel under the supervision of physicians specializing in sports medicine . The investigators will estimate the intensity level of participants using the HR reserve (HRR) method, beginning at 50% intensity (based on HR and feelings of exertion) and progressing to 70% intensity for a maximum of 40 minutes, 3 times per week. All exercise sessions of patients will be supervise by the physician and trained nurses and under ECG monitoring. Control group just follow up during the study and Will not participate in any exercise programs and will continue their own normal life activities. Data collection of demographic questionnaire and will be PHQ8 before and after the study period, both groups will be filled. The data was analyzed with SPSS version 21 .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605107844N10
Registration date: 2016-05-25, 1395/03/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kerman University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of exercise training on depressive symptoms in patients with heart failure, reffered to Cardiac rehabilitation center of Shafa Hospital, Kerman University of Medical Science in 2016
Public title
Effects of exercise training on depressive symptoms in patients with heart failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria were aged 40-75 years with a confirmed diagnosis of heart failure due to left ventricular systolic dysfunction (New York Heart Association functional classes II and III) and a history of symptoms and signs of heart failure at least 6 months, with left ventricular ejection fraction of 40% or less. Patients were excluded if they had acute myocardial infarction within 3 weeks; unstable angina pectoris; serious rhythm disturbance; symptomatic peripheral vascular disease; severe obstructive pulmonary disease, with a forced expiratory vital capacity 50% of expected as measured by spirometry; Acute systemic illness or fever ,Recent embolism , Acute pericarditis or myocarditis ,Supine resting HR >100bp ,Uncontrolled diabetes ,Decrease in SBP with exercise ,uncontrolled hypertension (resting blood pressure ≥160 mm Hg systolic or ≥90 mm Hg. Patients were also excluded due to an inability to exercise (e.g., severe musculoskeletal disorder,advanced valvular disease).
Age
From 40 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Department of Kerman University of Medical Sciences
Street address
Kerman, crossroads T. Abad (S.), the first jihad Blvd., St. Ibn Sina, Vice Chancellor for Research and Technology Building, first floor, Physiology Research Center, Kerman
City
Kerman
Postal code
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
ir.kmu.rec.1394.652

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
I50.1,I50.9

Primary outcomes

1

Description
Symptoms of Depression
Timepoint
Immediately before and after intervention
Method of measurement
The Patient Health Questionnaire (PHQ)-8)

Secondary outcomes

empty

Intervention groups

1

Description
Patients randomized to the Intervention group first participated in exercise program, with a goal of 3 sessions per week for a total of 24 sessions in 2 months. Each session includes 5-10 minutes warm-up, 20-40 minutes supervised training phase and 5-10 minutes of cooling and relaxing will be. During the supervised training phase, patients will exercise on a treadmill, stationary cycling and rowing Ergometer under Remote Monitoring, and will be done by trained personnel under the supervision of physicians specializing in sports medicine . The investigators will estimate the intensity level of participants using the HR reserve (HRR) method, beginning at 50% intensity (based on HR and feelings of exertion) and progressing to 70% intensity for a maximum of 40 minutes, 3 times per week..
Category
Rehabilitation

2

Description
Control Group: No action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac Rehabilitation Centerof Shafa Hospital
Full name of responsible person
Mazallahi Mahboobeh
Street address
Kerman highway Imam, campus Afzalipour Afzalipour Hospital
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Dr Pardakhti Abbas
Street address
Kerman, Tahmasebabad Crossroads, the first jihad Blvd., St. Ibn Sina, Vice Chancellor for Research and Technology Building, first floor, Physiology Research Center, Kerman
City
Kerman
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, Kerman 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
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Arab Mansoor
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 343135219
Fax
Email
marab@kmu.ac.ir; marab112004@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Kerman
Full name of responsible person
Arab Mansoor
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 34 3132 5219
Fax
Email
marab@kmu.ac.irmarab112004@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Razi Nursing and Midwifery School, Kerman University of Medical Sciences
Full name of responsible person
Arab Mansoor
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
7754312345
Phone
+98 34 3132 5219
Fax
Email
marab@kmu.ac.irmarab112004@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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