Protocol summary

Summary
The purpose of this study is to investigate the effect of eight weeks intra-dialytic aerobic training on Obestatin, GH, homocysteine, dialysis efficacy and physical performance of hemodialysis patients. Therefore, 18 hemodialysis patients referred to dialysis section of Najaf Abad’s Shahid Montazeri Hospital will be selected purposely as subjects and then randomly will be divided to two groups of experimental (N=9) and control (N=9). Intra-dialytic aerobic training program will be performed by experimental group for 8 weeks, 3 sessions per week with corresponded to 40 to 45 percent of their maximum heart rate reserve at the first week and ended with 65 to 70 percent at the final week .Blood samples and physical performance tests will be taken 48h before and 48h after the training period. Paired t-test will use for determining within group differences and independent t-test for determining between groups differences, respectively. Data will be analyzed at less than 0.05.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061528406N3
Registration date: 2016-06-19, 1395/03/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-19, 1395/03/30
Registrant information
Name
Akbar Azamian Jazi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 983814424411
Email address
azamian-a@lit.sku.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of intra-dialytic aerobic training on Obestatin, GH, homocysteine, dialysis efficacy and physical performance of hemodialysis patients.
Public title
The effect of intra-dialytic aerobic training on hemodialysis patients.
Purpose
Other
Inclusion/Exclusion criteria
Inclusion Criteria: Lack of heart disease; Lack of lung disease; Non-Musculoskeletal disorders Exclusion Criteria: Cardiovascular disease; Respiratory diseases; Movement disorders
Age
From 43 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients will be selected based on inclusion criteria and physical examinations (by the physician) and then will be randomly divided into intervention and control groups.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahrekord University Ethics Committee
Street address
Vice chancellor for research, Shahrekord University, Kilometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
190/107

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
Obestatin
Timepoint
Before and after 8 weeks of resistance exercise training
Method of measurement
Elisa Kit

2

Description
GH
Timepoint
Before and after 8 weeks of resistance exercise training
Method of measurement
Kit

3

Description
homocysteine
Timepoint
Before and after 8 weeks of resistance exercise training
Method of measurement
Elisa Kit

4

Description
dialysis efficacy
Timepoint
Before and after 8 weeks of resistance exercise training
Method of measurement
Kit

5

Description
physical performance
Timepoint
Before and after 8 weeks of resistance exercise training
Method of measurement
Physical activity tests

Secondary outcomes

empty

Intervention groups

1

Description
Interventionl group: Perform Intra-dialytic aerobic training (By Medi-bike).
Category
Lifestyle

2

Description
Control group: Don't receive any interventions
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Najaf Abad’s Shahid Montazeri Hospital
Full name of responsible person
Dr. Sharzad Shahidi
Street address
Internal Medicine Department, Faculty of Medicine, Isfahan University of Medical Sciences
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Street address
Vice chancellor for research, Shahrekord University, Kilometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
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 Shahrekord 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
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate professor)
Other areas of specialty/work
Street address
Department of Exercise Physiology, Shahrekord University, Kilometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate professor)
Other areas of specialty/work
Street address
Department of Exercise Physiology, Shahrekord University, Kilometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University
Full name of responsible person
Akbar Azamian Jazi
Position
PHD, Academic Staff (Associate professor)
Other areas of specialty/work
Street address
Department of Exercise Physiology, Shahrekord University, Kilometr 2 Jadeh Saman, Shahrekord, Iran
City
Shahrekord
Postal code
Phone
+98 38 1442 4411
Fax
Email
azamianakbar@gmail.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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