Semi-empirical methods applied to two groups (one experimental and one control) is. Thus the 22 diabetic patients with mild neuropathy severity voluntarily announced that they were selected and randomly divided into two groups . experimental group and control group, 12 patients were 10 people who participated in the briefing sessions, nutritional education (control diet) and specified times for control and measurements were made of sugar. After the experimental group (12 patients), 3 sessions a week in the gym or open field, light-intensity exercise at 45 to 55 minutes per day (50% of aerobic power) for 8 weeks and finally did the control group. (without exercise) were compared.
Independent variable: moderate-intensity aerobic exercise (60 to 75% and heart Hdaksrzrban) for 45 to 55 minutes a day, three days a week for 8 weeks.
Dependent variable: - dynamic equilibrium - dynamic equilibrium - walking speed - Blood Lipids - blood sugar - glycosylated hemoglobin Hb A1c, insulin resistance (IR)
General information
Acronym
DPN
IRCT registration information
IRCT registration number:IRCT2012120811696N1
Registration date:2013-01-18, 1391/10/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-18, 1391/10/29
Registrant information
Name
Mostafa Khoei Torbaqhan
Name of organization / entity
Ferdowsi University
Country
Iran (Islamic Republic of)
Phone
+98 51 1879 2763
Email address
mo_kh21@stu-mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Ferdowsi University
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
8 weeks of aerobic exercise on the impact of changes in the balance, walking speed and some blood parameters in diabetic neuropathy patients
Public title
8 weeks of aerobic exercise on the impact of changes in the balance, walking speed and some blood parameters in diabetic neuropathy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for this study were: aged 43-63 years with a body mass index 20 to 30 kg per square meter; the lack of and failure to report a history of foot ulcers, dizziness, inner ear infection, dislocation, ankle fractures, neurology and rheumatology deformity or disease in the lower extremities. Exclusion criteria: neurology and rheumatology at the lower extremity of illness, or lack of ability to perform activities such as walking was minimal.
Age
From 43 years old to 63 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ferdowsi University of Mashhad
Street address
Mashhad
City
Mashhad
Postal code
iran
Approval date
2012-12-10, 1391/09/20
Ethics committee reference number
238
Health conditions studied
1
Description of health condition studied
diabet-Diabetic Neuropathy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Static balance
Timepoint
2 months aerobic training
Method of measurement
measuring device for measuring the balance of the Balance System, Balance SD, 100 VAC (Company: BIODEX made in America) was used.
2
Description
Dynamic equilibrium
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
measuring device for measuring the balance of the Balance System, Balance SD, 100 VAC (Company: BIODEX made in America) was used.
3
Description
Walking speed
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
measure walking speed of 10 m with an accuracy of0/01 meters per sec (Q & Q models made in China) was used.
4
Description
insulin resistance
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
To measure insulin resistance, IR, fasting glucose measurements (FBS) (Pars test kits) Vansvlyn fasting laboratory kits METRA Dia (DIAMETRA) Made in Italy made a number DK 0076 ... Ratio of two to Ykdykr software, Homa (HOMA) version 1/2 was used to build America.
Secondary outcomes
1
Description
quality of life
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
To measure changes in quality of life questionnaire, 28-item WHOQOL-BRef American Society was used.
2
Description
fasting blood sugar (FBS).
Timepoint
Pre-Test - 2 months training - posttest
Method of measurement
To measure fasting glucose measurements (FBS) (Pars test kits) fasting laboratory kits (DIAMETRA) was used.
3
Description
insulin
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
measure insulin assay kit (DIAMETRA) Made in Italy were used to build number DK 0076. Laboratory using ELISA (ELISA) was performed.
4
Description
anxiety and depression
Timepoint
Pre-test and post-test 2 months of aerobic exercise
Method of measurement
To measure the changes in HADS anxiety and depression 14-item questionnaire was used.
Intervention groups
1
Description
After the experimental group (n = 12) weeks of 3 sessions in the gym or open field, took 45 to 55 minutes a day of exercise of moderate intensity (60 to 75% HRmax ) 8-week exercise conducted at the end of the control group. (without exercise) were compared.
Category
Behavior
2
Description
did not exercise regularly.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Diabetes
Full name of responsible person
Street address
Beginning Dehkhoda, Corner of Victory 15, Mashhad - R. City
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Physical Education
Full name of responsible person
Mahtab Moazami
Street address
Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of Physical Education
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ferdowsi University
Full name of responsible person
Mostafa Khoei
Position
Bachelor of Physical Education
Other areas of specialty/work
Street address
Ferdowsi University
City
Mashhad
Postal code
9149687313
Phone
+98 51 1879 2763
Fax
Email
khob.mostafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University
Full name of responsible person
Mostafa Khoei
Position
Bachelor of Physical Education
Other areas of specialty/work
Street address
Ferdowsi University
City
Mashhad
Postal code
9149687313
Phone
+98 51 1879 2763
Fax
Email
khob.mostafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University
Full name of responsible person
Mostafa Khoei
Position
Bachelor of Physical Education
Other areas of specialty/work
Street address
Ferdowsi University
City
Mashhad
Postal code
9149687313
Phone
+98 51 1879 2763
Fax
Email
khob.mostafa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)