This study will be conducted to evaluate the efficacy of Otago Exercise home training programme on Multidimensional Fatigue Syndrome (MFS) among female elderly patients with breast cancer in the Khansari hospital in Arak. The study sample will be 82 subjects whom will be divided in two control and experimental groups. The main inclusion criteria are being female, 60 years old and above and live with a female caregiver aged 15-50 with health literacy. Moreover, the main exclusion criteria are acute cardiac, pulmonary and orthopedic disease that have banned subjects from exercise. After completing the primary assessments, the Multidimensional Fatigue Syndrome in both groups, Otago home exercise training will be implemented on the intervention group and routine health education will be given to control group. Subjects of the study will be assigned randomly by random number table. ُ subjects of the study will be blinded to being in control or intervention group. After 12 weeks both groups will be assessed for MFS checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121216285N3
Registration date:2017-04-11, 1396/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-11, 1396/01/22
Registrant information
Name
Ali Dadgari
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
dadgari@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research; Sharoud University of Medical Sciences
Expected recruitment start date
2017-03-05, 1395/12/15
Expected recruitment end date
2017-05-15, 1396/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial on Effectiveness of Otago Exercise Training Programme on Multidimensional Fatigue Syndrome among Elderly Patients with Cancer
Public title
Clinical trial on Effectiveness of Otago Exercise Training Programme on Multidimensional Fatigue Syndrome among Elderly Patients with Cancer
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 years old and above
Being female
MMSE more than 12
Having a care giver in ages range between 15 and 50 years old with health literacy
Exclusion Criteria: The presence of acute cardiac, pulmonary, orthopedic or any disease which ban the subjects for doing exercises such as anemia
Age
From 60 years old to 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
82
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
Ethics Committee of sharoud University of Medical Sciences
Street address
Head Quarter of Sharoud university of medical sciences, Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.SHMU.REC.1395.157
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
CD50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Multidimensional Fatigue Syndrom
Timepoint
Before intervention- After intervention
Method of measurement
Multidimensional Fatigue Inventory Syndrom
Secondary outcomes
1
Description
Quality of Sleep
Timepoint
Before and After Intervention
Method of measurement
assessed by Sleep Quality Questionaire
2
Description
Neuromuscular pain
Timepoint
Before and after the intervention.
Method of measurement
Using Pain Questionnaire
3
Description
Feeding problems and weight loss
Timepoint
Before and after the intervention.
Method of measurement
Using BMI
4
Description
Stress
Timepoint
Before and after the intervention.
Method of measurement
Using Stress Questionnaire
Intervention groups
1
Description
Intervention group: Otago exercise is a training programme designed and conducted in University of Otago, New Zealand.
The exercise will be implemented for 12 weeks, 5 days per week for 40-60 minutes.
In control group. General health education will be provided to subjects based on instructions of Ministry of Health, Treatment and Medical Education for elderly people.
Category
Rehabilitation
2
Description
In subjects in intervention group Otago Exercise Programme will be implemented.
In control group general health education will be given
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah khansari Hospital
Full name of responsible person
Nafise Salehi-old graduate student-student
Street address
Markazi Province, Arak, the Street University
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Head Quarter of Shahroud University of Medical Sciences, Hafte Tir Square, Shahroud
City
Shahroud
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; Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Ali Dadgari
Position
PhD in Gerontology
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square,shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 4499
Fax
Email
adadgri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ali Dadgari
Position
PhD in Gerontology
Other areas of specialty/work
Street address
Head Quarter of Shahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 4499
Fax
Email
adadgari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Nafiseh Salehi
Position
Master of Ggerontology
Other areas of specialty/work
Street address
Hospital Ayatollah khansari, University Avenue, Arak
City
Arak
Postal code
Phone
+98 86 3368 1641
Fax
Email
salehi.8241@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)