Protocol summary

Summary
Aim: Fatigue is the most common and bothersome symptom in hemodialysis patients, so that almost half of them experience fatigue during their treatment for renal failure. The aim of this study is to investigate the effect of a designed exercise program on fatigue in hemodialysis patients. Methods: In a quasi-experimental design, 25 hemodialysis patients from three hospitals of the medical university of Tehran in 2010 were chosen. The patients in the experimental group (n=12) followed a designed exercise program 3 days per week, which lasted for 8 weeks. The subjects in the experimental group had to exercise for 20 minutes immediately after dialysis session followed by a 10-minute bed rest and deep slow breaths, with their eyes closed. Control group receive routine care. The Fatigue Severity Scale (FSS) questionnaire was used to measure the participants’ fatigue, three times, before the exercise program and four and eight weeks after the exercise program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102162226N2
Registration date: 2012-04-30, 1391/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Mansooreh Aliasgharpour
Name of organization / entity
Nursing & midwifery faculty, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 7120
Email address
aliasgha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-04-14, 1389/01/25
Expected recruitment end date
2010-07-04, 1389/04/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of designed exercise program on the fatigue in hemodialysis patients
Public title
Effects of designed exercise program on the fatigue in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 65 years old; performing hemodialysis treatment for at least six months; no history of intensifying of the disease during the last six months; no participation in any regular exercise program during the last six months; no specific orthopedic problems in walking; no cardiovascular disease and severe shortness of breath and heart failure preventing from the performance of the exercise program. Exclusion criteria: absence in four sessions during the exercise program and not willing to continuing the exercise program.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
Street address
Tohid squere
City
Tehran
Postal code
Approval date
2010-04-07, 1389/01/18
Ethics committee reference number
465/130/s/89

Health conditions studied

1

Description of health condition studied
fatigue in hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Care involving dialysis

Primary outcomes

1

Description
Fatigue
Timepoint
At the start and at the end of the fourth and eighth weeks of the exercise program
Method of measurement
Fatigue Severity Scale

Secondary outcomes

1

Description
Exercise program
Timepoint
Immediately after the end of hemodialysis session
Method of measurement
Tolerance time check list

Intervention groups

1

Description
The exercise program included four stages: A) starting with warm-up by slow walking for 5min till the body would be ready, B) walking fast based on the patient’s tolerance (10 min), C) slow walking and body cooling (5 min) and D) 10 min of rest and relaxation.
Category
Prevention

2

Description
Control group: routine care
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals affliated to Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
nursing & midwifery faculty, Tehran university of medical sciences
Full name of responsible person
Dr.Negharandeh
Street address
nosrat east-Toohid square-medical sciencess of tehran university-nursing&midwifery faculty
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
nursing & midwifery faculty, Tehran 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
Faculty of Nursing and Midwifery, Tehran university of mdical sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
academic member
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Nosrat st.,Toohid square
City
Tehran
Postal code
Phone
+98 912 360 5329
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Tehran university of mdical sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
MS
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Nosrat st.,Toohid square
City
Tehran
Postal code
Phone
+98 912 360 5329
Fax
Email
aliasgha@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansooreh Aliasgharpour
Position
Faculty member
Other areas of specialty/work
Street address
Faculty of Nursing & Midwifery, Nosrat st.,Toohid square
City
Postal code
Phone
Fax
Email
aliasgha@sina.tums.ac.ir
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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