To investigate the effect of circular resistance training on arterial stiffness in type 2 diabetic men with peripheral neuropathy
Design
A clinical trial with control group, parallel design, double blind and randomized design. sample size is 30.
Settings and conduct
Three months supervised circuit resistance training with the intensity with the frequency of 3 sessions per week will be conducted at the laboratory of sport physiology of Shahrood university of technology. The samples size in this study will be 30. The measurements will be performed at baseline and 48 hours following the last exercise session in a fasting state. In this study the instructor and the participants will not be blinded to the group allocation but laboratory specialists and data analyst will be blinded to the group allocation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of type 2 diabetes for more than 5 years;
diagnose of peripheral neuropathy by a neurologist;
hemoglobin A1c over 6.6%;
no restriction for exercise;
sedentary life-style.
Non-inclusion criteria: regular exercise training;
orthopedic problems;
heart surgery.
Intervention groups
Resistance training group: after 2 weeks of familiarization, participants will perform circuit resistance training over 3 months with the frequency of 3 days a week.
Control group: they will be required to maintain daily physical activity.
Effect of circuit resistance training on arterial stiffness in type 2 diabetic men with peripheral neuropathy
Public title
Circuit resistance training and arterial stiffness in neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of type 2 diabetes for more than 5 years
diagnose of peripheral neuropathy by a neurologist
HbA1c over 6.6%
No restriction for exercise
Sedentary life-style
Exclusion criteria:
regular exercise training
Orthopedic problems
Heart Surgery
Age
From 30 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be enrolled by one of the research colleagues. A person, blinded to group allocation will provide a random allocation sequence using computer software of SAS prior to the initiation of the study to be used to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 4, 6) will be applied to ensure an equal number of participants in each group. Group allocation will be concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes will be opened after the enrolled participants are analyzed. In this study the instructor and participants will not be blinded to the group allocation but laboratory specialists and data analyst will be blinded to the group allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study the instructor and participants will not be blinded to the group allocation but laboratory specialists and data analyst will be blinded to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud university of medical sciences
Street address
7-Tir Square., Tehran St.
City
Shahroud
Province
Semnan
Postal code
3614773947
Approval date
2019-09-30, 1398/07/08
Ethics committee reference number
IR.SHMU.REC.1398.087
Health conditions studied
1
Description of health condition studied
Peripheral Neuropathy of Type 2 Diabetes
ICD-10 code
E11.42
ICD-10 code description
Type 2 diabetes mellitus with diabetic polyneuropathy
Primary outcomes
1
Description
Ankle-brachial index
Timepoint
Before and after the intervention
Method of measurement
Arterial stiffness analyzer
2
Description
Toe-brachial Index
Timepoint
Before and after the intervention
Method of measurement
Arterial stiffness analyzer
3
Description
Cardio-ankle vascular stiffness index
Timepoint
Before and after the intervention
Method of measurement
Arterial stiffness analyzer
4
Description
Score of neuropathy symptomes
Timepoint
Before and after the intervention
Method of measurement
Michigan diabetic neuropathy score
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and after the intervention
Method of measurement
Blood pressure monitor
2
Description
Diastolic blood pressure
Timepoint
Before and after the intervention
Method of measurement
Blood pressure monitor
3
Description
Fasting blood glucose
Timepoint
Before and after the intervention
Method of measurement
Calorimetric method
Intervention groups
1
Description
Intervention group: Circuit resistance training over 3 months with the frequency of 3 sessions per week and 36 sessions in total, with the intensity of 50-70% of one repetition maximum .
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 Shahroud
Full name of responsible person
Farhad Gholami
Street address
7-Tir Square., Tehran St.
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
info@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud Unversity of Technology
Full name of responsible person
Ali Dastfan
Street address
7-Tir Square,. Tehran St.
City
Shahroud
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
Shahroud Unversity 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
Shahroud University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercsie physiology
Street address
7-Tir Square,. Tehran St.
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
gholami.farhaad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Farhad Gholami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercsie physiology
Street address
7-Tir Square,. Tehran St.
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 5900
Email
gholami.farhaad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Technolgy
Full name of responsible person
Farhad Gholami
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
7-Tir Square., Tehran St.
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 32395900
Email
gholami.farhaad@gmail.com
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
Undecided - It is not yet known if there will be 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
No decision has been made.
When the data will become available and for how long
No decision has been made.
To whom data/document is available
No decision has been made.
Under which criteria data/document could be used
No decision has been made.
From where data/document is obtainable
No decision has been made.
What processes are involved for a request to access data/document