Determining the effect of planned walking on cancer-related fatigue in patients with acute leukemia under chemotherapy
Design
In this pretest-post test study, 50 eligible patients with acute myelogenous leukemia who were referred to Shafa hospital were selected.
Settings and conduct
This study was carried out in a referral teaching hospital as the only specialized cancer and chemotherapy hospital in the south west of Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 18 years and older; being diagnosed with acute AML or the recurrence of AML; taking part in at least two chemotherapy sessions at the time of this study.
Exclusion criteria: History of underlying diseases such as cardiovascular disease, diabetes and hypertension, other cancers, inability to attend two walking sessions, hemodynamic instability, discharge from the hospital or death, life expectancy less than one month, and intractable and uncontrolled pain
Intervention groups
The intervention group consisted of only one group (pre test-post test) and there was no control group. The patients were assigned to two groups of males and females to facilitate the implementation of the walking exercise program in each gender group. The patients walked slowly in the warm-up phase and took deep breathing and then entered the main walking program including a 10-minute quick-paced walking. Subsequently, the patients were asked to walk in a slow pace to feel their heartbeat and do cool down exercises for 5 minutes. After the walking exercise program, the patient laid on the bed and breathed deeply for ten minutes, and their vital signs were measured again by the researcher. In the fifth day and tenth day of the intervention, the BFI was completed again.
Main outcome variables
cancer-related fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091017002599N2
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
shahram baraz
Name of organization / entity
ahwaz joundishapour university medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8333
Email address
shahrambaraz@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the Planned Walking Exercise Program on Cancer-related Fatigue among Patients with Acute Myeloid Leukemia Undergoing Chemotherapy
Public title
The effect of planned walking on fatigue of patients with acute leukemia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being 18 years old and over
being diagnosed with acute AML or the recurrence of AML
taking part in at least two chemotherapy sessions
Exclusion criteria:
history of underlying diseases including cardiovascular diseases, diabetes mellitus and hypertension and any other cancers
Inability to attend walking tours
Unstable hemodynamic status
Hospital discharge or death
Life expectancy less than a month
Uncontrollable pain
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Jundishapur University of Medical Sciences
Street address
School of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2016-12-03, 1395/09/13
Ethics committee reference number
IR.AJUMS.REC.1395.663
Health conditions studied
1
Description of health condition studied
Acute Myeloid Leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
The score obtained from The Brief Fatigue Questionnaire (BFI)
Timepoint
Fatigue measurement at the beginning of the study, 5 and 10 days after the planned walking
Method of measurement
The Brief Fatigue Questionnaire (BFI)
Secondary outcomes
1
Description
Fatigue interference with everyday life activities
Timepoint
Before the intervention, 5 and 10 days after the intervention
Method of measurement
The Brief Fatigue Questionnaire (BFI)
Intervention groups
1
Description
Intervention group: The researcher provided a quiet and private place in the hospital’s courtyard to perform the walking exercise program . Before each session, the patients’ vital signs including blood pressure, pulse and respiratory rate were measured by the researcher. The patients were assigned to the group of males and females to facilitate the implementation of the walking exercise program in each gender group. Similar to the intervention by Wenzel et al. (2013), the patients were asked to perform a 30-minute walk program in two 5-day non-stop periods and within a specified time each day in the following phases: warm-up and preparing the body (5 minutes), a fast-paced walking on the basis of their tolerance (10 minutes), slow-paced walking and body cooling (5 minutes) followed by 10 minutes of rest and relaxation. The patients walked slowly in the warm-up phase and took deep breathing and then entered the main walking program including a 10-minute quick-paced walking. Subsequently, the patients were asked to walk in a slow pace to feel their heartbeat and do cool down exercises for 5 minutes. After the walking exercise program, the patient laid on the bed and breathed deeply for ten minutes, and their vital signs were measured again by the researcher. In the fifth day and tenth day of the intervention, the BFI was completed again.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Shahram Baraz
Street address
school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
13570088611
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
shahrambaraz@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Street address
school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
88611135700
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
shahrambaraz@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
shahram baraz
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, University square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
88611135700
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
shahrambaraz@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
88611135700
Phone
+98 61 3373 8333
Fax
+98 61 3373 8331
Email
shahrambaraz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Baraz
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
school of nursing and midwiferry, Ahvaz Jundishapur University of Medical sciences, Golestan Blvd, Daneshgah square,Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
88611135700
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
shahrambaraz@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A portion of the original outcome data is shared
When the data will become available and for how long
Starting the access period from 2020
To whom data/document is available
The data will only be available to academic researchers
Under which criteria data/document could be used
Requests for doing a systematic review and meta-analysis of data are available
From where data/document is obtainable
Contact the email of the author
What processes are involved for a request to access data/document