Comparing the effect of Walking and Yoga on Sexual Health and Quality of Life in Type 2 Diabetic male patients
Design
This randomized clinical trial will be conducted on three groups of males with type 2 diabetes visiting the specialized clinics at Golestan and Imam Khomeini Hospitals in Ahvaz
Settings and conduct
This randomized clinical trial will be conducted on three groups of males with type 2 diabetes visiting the specialized clinics at Golestan and Imam Khomeini Hospitals in Ahvaz. After obtaining the permission of the University Research Deputy and the ethical code from the Ethics Committee of the University, the researcher will visit the research environment and the mentioned clinics and will explain the research objectives to the authorities.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Diagnosis of diabete not less than one year ago
Not participating in other sporting programs concurrently
Not suffering from diseases that do
not allow physical activity Married
Not having physical limitations that prevent physical activity
Not undergoing insulin therapy Not taking antidepressants
30-60 years old
Exclusion criteria
Hospitalization during the intervention
Changing treatment from oral medication to insulin therapy Moving to another city, Suffering from diseases and complications that limit physical activity during the research project
Intervention groups
,One of the intervention groups will engage in yoga (three 60-minute sessions per week for 8 weeks) under the supervision of a professional researcher and coach in a sports hall. Each session will include warm up, body movements and breathing exercises, relaxation and meditation. The other intervention group will walk after eating breakfast (three 60-minute sessions per week for 8 weeks).
Main outcome variables
Sexual function; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180511039610N1
Registration date:2018-06-15, 1397/03/25
Registration timing:prospective
Last update:2018-06-15, 1397/03/25
Update count:0
Registration date
2018-06-15, 1397/03/25
Registrant information
Name
Bayan saberipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 6702
Email address
saberipour.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Walking and Yoga on Sexual Health and Quality of Life in Type 2 Diabetic male patients
Public title
Effect of Walking and Yoga on Sexual Health and Quality of Life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of diabetes not less than one year ago
Not participating in other sporting programs concurrently
Not suffering from diseases that do not allow physical activity
Married
Not having physical limitations that prevent physical activity
Not undergoing insulin therapy
Not taking antidepressants
30-60 years old
Exclusion criteria:
Hospitalization during the intervention
Suffering from diseases and complications that limit physical activity during the research project
Age
From 30 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
A sample in this study of 108 patients with type 2 diabetes referred to specialized diabetes clinics in Golestan and Imam Khomeini hospitals who are eligible to enter the study. Qualified individuals are randomly assigned to three groups (walk group, yoga group, and control group) using random block random blocks (Block 6) (using a random permutation table). A randomized list is provided by a statistician. According to the randomized list, the code is assigned by a person outside the study according to the codes corresponding to each disease that is included in the study.
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 Ahvaz University of Medical Sciences
Street address
plain 16-Alley of Arasham-In between the Great and the Masjid-Nazari Pour-Ahwaz
City
ahvaz
Province
Khouzestan
Postal code
6195734733
Approval date
2018-05-04, 1397/02/14
Ethics committee reference number
IR.AJUMS.REC.1397.101
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Quality of Life
Timepoint
(Before the intervention), 4 and 8
Method of measurement
quality of life questionnaires -SF36
Secondary outcomes
1
Description
Sexual function
Timepoint
(Before the start of intervention), 4 and 8
Method of measurement
Standard Sexual Function Questionnaire for Rosen Men
Intervention groups
1
Description
Intervention group1,2:One of the intervention groups will engage in yoga (three 60-minute sessions per week for 8 weeks) under the supervision of a professional researcher and coach in a sports hall. Each session will include warm up, body movements and breathing exercises, relaxation and meditation. The two intervention group will walk after eating breakfast (three 60-minute sessions per week for 8 weeks).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
specialized clinics at Golestan and Imam Khomeini Hospitals