Protocol summary

Summary
Objectives: Determination of the effect of Hatha Yoga on the quality of life in hemodialysis patients. Design: This study is a clinical trial that performed for an experimental and control groups. Setting and conduct: researcher does the sampling based on objective among all the patients who are admitted to the Hemodialysis Department of 5 Azar hospital in Gorgan with the Population size of 174 people, (89 men and 85 women). The sample size is 16 people, so 32 patients are assigned and placed in experimental and controls groups of 16 people, randomly. For adjustment of gender variable in sampling based on objective, 16 female patients from women group and 16 male patients from men group of research community selected, Then based on a random numbers table, from each group of 16 male and female, 8 female and 8 male patient placed in experimental group and 8 female and 8 male patient in control group, randomly. Thus 2 experimental and control groups are selected and experimental group similar to the control group includes 8 male and 8 female who have all the Inclusion criteria and the only difference is Hatha Yoga intervention that is done for the experimental group. Data collection tool is a questionnaire consists of two parts include demographic information and quality of life questionnaire SF36. First, the quality of life of patients in both groups checked. During the 12 weeks, each week two times, Patients in the experimental group will participate in the training sessions of Hatha yoga which will be held in the Sports Hall of Hospital by master trainer who has a history of training. After 12 weeks, the patients' life quality in groups will re-examine and compare. Participants including major eligibility criteria: 3 months have passed since the first turn of hemodialysis of patients. Be interested in participating in the study, filling out the questionnaire and attending the Hatha Yoga exercise classes. Not being membership of yoga classes. Participants excluding major eligibility criteria: Absence of more than 4 sessions of 24 session training class, Withdrawal or reluctance to exercise during the study. Interventions: in 12 weeks, 2 times each week (A total of 24 sessions), Patients in the experimental group will participate in the training sessions of Hatha yoga which will be held in the Sports Hall of Hospital by master trainer who has a history of training. Training sessions of male and female patients will be separate and held with a separate instructor. The main outcome variable: Quality of life of Hemodialysis patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015113024047N3
Registration date: 2016-10-08, 1395/07/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-08, 1395/07/17
Registrant information
Name
Hedayat Jafari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7268
Email address
hjafari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Hatha Yoga exercises on the quality of life in Hemodialysis patients
Public title
Effects of Hatha Yoga exercises on the quality of life in Hemodialysis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: 3 months have passed since the first turn of Hemodialysis of patients ؛ Be interested in participating in the study, filling in the questionnaire and attending the Hatha Yoga exercise classes ؛ Not being membership of yoga classes ؛ Be educable (patients with consciousness 15/15, with abstract thinking, without interrupting the focus is known about mental Retard, Alzheimer's disease, stroke that lead to memory impairment and movement and be able to exercise independently on the slopes motion. so they can learn and perform yoga movements) ؛ Have confirmation of doctor for doing exercise ؛ Not doing physical activity at least three times a week ؛ not using of complementary therapies simultaneously with the intervention ؛ Not being membership in yoga classes. Participants excluding major eligibility criteria: Absence of more than 4 sessions of 24 session training class؛ Withdrawal or reluctance to exercise during the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Mazandaran University of Medical Science
Street address
Moalem Street, Moalem Square, Sari
City
Sari
Postal code
4815696869
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.MAZUMS.REC.95

Health conditions studied

1

Description of health condition studied
end stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5

Primary outcomes

1

Description
Quality of life
Timepoint
Before and 3 months after the intervention
Method of measurement
SF36 quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group at 3 months (12 weeks, 2 times per week) of the patients in the hospital for 60 minutes sessions of Hatha yoga exercises that will be held in the presence of coach, participated SF36 quality of life questionnaire before and after intervention by the Group the intervention is completed.
Category
Lifestyle

2

Description
In the control group there is no intervention and they will just fill in the SF36 quality of life questionnaire before and after the intervention of experiment group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
5 Azar Hospital of Gorgan city
Full name of responsible person
Elahe Mahmudi
Street address
Hemodialysis department, 5 Azar Hospital, Azar Street, Vali Asr Square, Gorgan. Iran.
City
Gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research Mazandaran University of Medical Sciences.
Full name of responsible person
Dr. Ahmahali Enayati
Street address
Vice Chancellor for research Mazandaran University of Medical Sciences, Moalem Street ,Moalem Square,Sari, Iran.
City
Sari
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 Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Eelahe Mahmudi
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran.
City
Sari
Postal code
4815696869
Phone
+98 17 3254 4053
Fax
Email
elahe.mahmudi304@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat Jafari
Position
Assistant Professor, scientific committee
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran
City
Sari
Postal code
4815696869
Phone
+98 11 3379 5555
Fax
Email
hedayat2003@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Elahe Mahmudi
Position
MSc in critical care nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery Mazandaran University of Medical Sciences, Vessal Street Sari, Iran
City
Sari
Postal code
4815696869
Phone
+98 17 3254 4053
Fax
Email
elahe.mahmudi304@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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