The acute effect of aerobic exercise with and without external load on blood glucose and blood pressure parameters in patients 40-60 years old with type 2 diabetes
Immediate effect of aerobic exercise with and without external load on blood glucose and blood pressure in patients with type 2 diabetes
Design
Clinical trial with a control group, with parallel, single-blind, randomized groups
Settings and conduct
The statistical population of this study is diabetics who refer to the Diabetes Center of Hamadan Province. People with type 2 diabetes, who have inclusion criteria, are classified into two groups: aerobic exercise and aerobic exercise by applying external load and control group, and then evaluated. The sampling method will be random
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age between 40 and 60 years
At least 2 years of type 2 diabetes
Lack of hypertension (Systolic pressure less than 16 mm Hg)
Do not use insulin
Exclusion criteria
Feeling tired during exercise
Feeling short of breath during exercise
Intervention groups
First group (aerobic group): Treadmill walk for 30 minutes
Second group (outdoor aerobic group): apply the weight of the weighted vest while walking on the treadmill
Control group: without aerobic exercise
Main outcome variables
Blood glucose levels before and after the intervention
Blood pressure before and after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190202042581N3
Registration date:2020-04-29, 1399/02/10
Registration timing:prospective
Last update:2020-04-29, 1399/02/10
Update count:0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Mohammad Reza Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3423 0949
Email address
m.asadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The acute effect of aerobic exercise with and without external load on blood glucose and blood pressure parameters in patients 40-60 years old with type 2 diabetes
Public title
The effect of aerobic exercise on blood glucose and blood pressure in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 60 years
At least 2 years of type 2 diabetes
Lack of hypertension (Systolic pressure less than 16 mm Hg)
Do not use insulin
Exclusion criteria:
Feeling tired during exercise
Feeling short of breath during exercise
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.UMSHA.REC.1399.049
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Blood glucose level
Timepoint
Before and after the intervention in each session
Method of measurement
Glucose measuring device
2
Description
Blood pressure level
Timepoint
Before and after the intervention in each session
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In this group, aerobic exercise, including walking on a treadmill, is performed for 30 minutes with an intensity of about 50% of the maximum heart rate and for one session
Category
Rehabilitation
2
Description
Intervention group 2: In this group, aerobic exercise with external load, including walking on a treadmill with weightlifting, is performed for 30 minutes with an intensity of about 50% of maximum heart rate and for one session.
Category
Rehabilitation
3
Description
Control group: Without aerobic exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Center of Hamadan Province.
Full name of responsible person
Solmaz Rahbar
Street address
Hamedan University of Medical Sciences, Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1633
Email
s.rahbar@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Deputy of Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
S_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
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
Hamedan University of Medical Sciences
Full name of responsible person
Solmaz Rahbar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School, Hamedan university of Medical sciences, Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1633
Email
s.rahbar@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Solmaz Rahbar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School, Hamedan university of Medical sciences, Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 1633
Email
s.rahbar@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hamedan university of medical sciences, Famideh Blvd,
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3423 0949
Fax
Email
m.asadi@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD