To investigate the effect of aerobic exercise on lower limb blood flow in men with type 2 diabetes and peripheral neuropathy.
Design
A randomized clinical trial with control group and parallel design, with no blinding and a sample size of 35.
Settings and conduct
Three months supervised aerobic training with the intensity of 50% to 70% of one heart rate reserve with the frequency of 3 sessions per week were conducted at the laboratory of sport physiology of Shahrood university of technology. Aerobic training included pedaling on cycle ergometer. The measurements were performed at baseline and 48 hours following the last exercise session in a fasting state. It was impossible to blind the participants and instructor to group allocation but laboratory specialists and data analyst were blinded to the group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age range of 30-70 years, Diagnosis of Type 2 diabetes for more than 5 years, HbA1c over 6.6%, Sedentary life-style, No restriction for exercise.
Intervention groups
Aerobic training group: participants underwent aerobic training on cycle ergometer over 3 months with the frequency of 3 days a week at the intensity of 50 to 70% of heart rate reserve. Control group: they were required to maintain daily physical activity.
Main outcome variables
flow mediated dilatation; intima media thickness; mean blood velocity and time to peak diameter of superficial femoral artery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170120032066N3
Registration date:2019-05-13, 1398/02/23
Registration timing:retrospective
Last update:2019-05-13, 1398/02/23
Update count:0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Farhad Gholami
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 41332395900
Email address
gholami-fa@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-08, 1397/02/18
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
2018-05-08, 1397/02/18
Actual recruitment end date
2018-06-05, 1397/03/15
Trial completion date
2018-09-08, 1397/06/17
Scientific title
Effect of 12-week aerobic exercise on glycemic control and lower limb blood flow in type-2 diabetic men with peripheral neuropathy
Public title
Aerobic exercise and lower limb blood flow in diabetic peripheral neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age ranges from 30 to 70 years
Diagnosis of type 2 diabetes for more than 5 years
HbA1c over 6.6%
Sedentary life-style
No restriction for exercise
Exclusion criteria:
Age
From 30 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were enrolled by one of the research colleagues. A person, blinded to group allocation were provide a random allocation sequence using computer software of SAS prior to the initiation of the study that were used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) were applied to ensure an equal number of participants in each group. Group allocation were concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes were opened after enrolled participants completed all baseline assessments. It was impossible to blind the participants and instructor to group allocation but laboratory specialists assessing the variables and data analyst were blinded to the group allocation.
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 Sport sciences research institute of Iran
Street address
No.3, 5th St., MirEmad St., Motahari Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.SSRC.REC.1398.011
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus with diabetic polyneuropathy
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Flow mediated dilation (FMD) in superficial Femoral artery
Timepoint
before and after the intervention
Method of measurement
Color-Doppler sonography
2
Description
Intima media thickenss of superficial Femoral artery
Timepoint
before and after the intervention
Method of measurement
Color-Doppler sonography
3
Description
Mean blood velocity in superficial Femoral artery
Timepoint
before and after the intervention
Method of measurement
Color-Doppler sonography
4
Description
Time to peak diameter of superficial Femoral artery
Timepoint
before and after the intervention
Method of measurement
Color-Doppler sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: aerobic exercise training on cycle ergometer at the intensity of 50% to 70% of reserved heart rate with the frequency of 3 session per week for 12 weeks.
Category
Rehabilitation
2
Description
Control group: no further activity other than daily physical activity
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Pasargad Clinic of Shahrood
Full name of responsible person
Farhad Gholami
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Ali Dastfan
Street address
7-Tir Square., Tehran St.
City
ُShahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
info@shahroodut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrood University of Technology
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
Shahrood University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+93 2332395900
Email
Gholami-fa@shahroodut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
Gholami-fa@shahroodut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
7-Tir Square., Tehran St.
City
Shahrood
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
Gholami-fa@shahroodut.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no further information
When the data will become available and for how long
There is no further information
To whom data/document is available
There is no further information
Under which criteria data/document could be used
There is no further information
From where data/document is obtainable
There is no further information
What processes are involved for a request to access data/document