The aim of the present study was to examine the effect of aerobic training on neural conduction and glucose control in type-2 diabetic men with peripheral neuropathy.
This is a non-blinded parallel-designed clinical trial in which eligible patients were randomly assigned into experimental or control groups. The inclusion criteria included being at the age of 30 to 60 years; type 2 diabetes; diabetes history for over 5 years; HbA1C more than 6.6%; diagnosed by a physician; abnormal electrodiagnostic examination confirming peripheral neuropathy. The exclusion criteria included type-1 diabetes; insulin therapy; exercising regularly and having a restriction for exercise participation. In this study, 32 participants from Shahid Mahalati and Emam Reza hospitals were randomly assigned into experimental or control groups. Exercise intervention included 20 to 45 minutes walking and running with 50 to 70 percent of heart rate reserve, three sessions per week during 12 weeks. Throughout the study course, participants in control group received no intervention and were asked to continue habitual physical activity. Before and 48h after the experimental period, body composition measurements and blood sampling for glucose analysis were performed. Moreover, nerve conduction studies (NCS) on sural, proneal and tibial nerves in lower limbs were performed. The primary outcomes included nerve conduction velocity and nerve action potential amplitude and the secondary outcomes included glucose and lipid profile indices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012032066N1
Registration date:2017-03-09, 1395/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-09, 1395/12/19
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
Private
Expected recruitment start date
2015-06-05, 1394/03/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic training on neural conduction and glucose control in type-2 diabetic men with peripheral neuropathy.
Public title
Effect of exercise on diabetic peripheral neuropathy.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: being at the age of 30 to 60 years; type 2 diabetes; diabetes history for over 5 years; HbA1C more than 6.6%; diagnosed by a physician; abnormal electrodiagnostic examination confirming peripheral neuropathy.
Exclusion criteria: type-1 diabetes; insulin therapy; exercising regularly and having a restriction for exercise participation
Age
From 30 years old to 60 years old
Gender
Male
Phase
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
Patients were randomly assigned into groups using random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Approval date
2015-05-27, 1394/03/06
Ethics committee reference number
TBZMED.REC.1394.153
Health conditions studied
1
Description of health condition studied
Diabetic Polyneuropathy
ICD-10 code
G63.2
ICD-10 code description
Diabetic polyneuropathy (E10-E14 with common fourth character .4+)
Primary outcomes
1
Description
Nerve conduction velocity
Timepoint
Before and after the intervention
Method of measurement
Using EMG system; in terms of meter/second
Secondary outcomes
1
Description
Plasma glucose
Timepoint
Before and after intervention
Method of measurement
Using specific kit; in terms of miligram/desiliter
2
Description
Lipid profile
Timepoint
Before and after intervention
Method of measurement
Using specific kit; in terms of miligram/desiliter
3
Description
Glycosylated hemoglobin (HbA1c)
Timepoint
Before and after intervention
Method of measurement
Using specific kit; in terms of percent
Intervention groups
1
Description
Control group: Without exercise intervention. Throughout the study period control group were asked to continue habitual physical activity.
Category
Lifestyle
2
Description
Intervention group: aerobic exercise training including walking or running for 20 to 45 minutes at the intensity of 50% to 70% of heart rate reserve, 3 days a week, through 12 weeks.