Protocol summary

Summary
Objective: The aim of this study was to examine the effects of 12 weeks Aerobic, Strength and Concurrent Training on Heart Rate Variability (HRV) and some specification of heart structural in Type-2 Diabetic Neuropathy Men. Design: 60 male diabetic Neuropathy patients divided randomized into four groups: control (n=15), aerobic training (n=15), Strength training (n=15) and Concurrent training (n=15). Participants including major eligibility criteria: age 30-70 year; diabetic duration > 3 year; HbA1c ≥ 6.5; FBS≥ 126 mg/dL; GTT ≥ 200 mg/dL; lack of regular physical activity, Lack of medical Prohibition from physical activity. Participants’ exclusion major eligibility criteria: Cardiovascular disease; Cancer; Suspected Heart Disease; BMI > 40 kg; Absence from the exercise. The experimental group participated 3 sessions per week for 12 weeks based on the training schedule with defined intensity and duration (according to the standard protocol). Control group received no intervention. At the end of the third month, NCV and HRV tests, structural and functional characteristics of the heart, hematology, biochemistry, VO2MAX and body composition conducted again. The participants will not be trained for a month (Detraining) and for assessment the effect of detraining, the aforementioned tests will be taken again. Exercise training are an independent variables and heart rate variability, structural and functional characteristics are dependent variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042227529N1
Registration date: 2017-05-01, 1396/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Elaheh Piralaiy
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 1696
Email address
epiralaiy@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-04-08, 1395/01/20
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 12 Weeks Aerobic, Strength and Concurrent Training on Heart Rate Variability (HRV) and some Specification of Heart Structural in Type-2 Diabetic Neuropathy Men
Public title
Effects of Exercise on Heart Rate Variability and Specification of Heart Structural in Diabetic Neuropathy Men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 30-70 Year; diabetic duration > 3 year; suffering from peripheral neuropathy; HbA1c ≥ 6.5; FBS≥ 126 mg/dL; GTT ≥ 200 mg/dL; lack of regular physical activity, Lack of medical Prohibition from physical activity Exclusion criteria: Cardiovascular disease; Cancer; Suspected Heart Disease; BMI > 40 kg/m2; Absence from the exercise
Age
From 30 years old to 70 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Central Building- Number 2, Tabriz University of Medical Sciences, Golgasht St
City
Tabriz
Postal code
+98
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.TBZMED.REC.1395.754

Health conditions studied

1

Description of health condition studied
Type-2 Diabetic Neuropathy
ICD-10 code
G63.2*
ICD-10 code description
Diabetic polyneuropathy

Primary outcomes

1

Description
HRV
Timepoint
Pre test; mid test 1; mid teat 2; post test
Method of measurement
Holter Monitoring VX3+

2

Description
Specification of Heart Structural and Functional
Timepoint
pre test; post test
Method of measurement
Echocardiography

3

Description
Hematology
Timepoint
pre test; post test
Method of measurement
Cell Counter

4

Description
Fbs, GTT
Timepoint
pre test; post test
Method of measurement
spectrophotometry

5

Description
Cholesterol; Triglycerides; HDL; LDL
Timepoint
pre test; post test
Method of measurement
spectrophotometry

6

Description
Insulin
Timepoint
pre test; post test
Method of measurement
Indirect immunofluorescense (IFA)

7

Description
Body Composition
Timepoint
Pre test; mid test 1; mid teat 2; post test
Method of measurement
Body Composition Monitor

8

Description
Gas Analysis
Timepoint
pre test; post test
Method of measurement
Cortex Gas Analyser

9

Description
Anthropomorphic Indices
Timepoint
Pre test; mid test 1; mid test 2, post test
Method of measurement
Tape Measure

10

Description
Neuropathy
Timepoint
pre test; post test
Method of measurement
NCV test

11

Description
HbA1c
Timepoint
pre test, post test
Method of measurement
Bronate Affinity Assey

Secondary outcomes

1

Description
Quality of Life
Timepoint
Pre test; mid test 1; mid test 2; post test; detraining
Method of measurement
WHO quality of life-BREF 26 questionnaire; SF-36 questionnaire

2

Description
Insulin Resistance
Timepoint
pre test; post test
Method of measurement
HOMA-IR

3

Description
Depression
Timepoint
Pre test; mid test 1; mid teat 2; post test; detraining
Method of measurement
Beck's Depression Inventory

4

Description
Medicinal Plants
Timepoint
Pre test; mid test 1; mid teat 2; post test; detraining
Method of measurement
Interview and Questionnaire

5

Description
Family History of Diabetes
Timepoint
In the past and during the research
Method of measurement
Interview and Questionnaire

6

Description
Self Efficacy
Timepoint
Pre test; mid test 1; mid teat 2; post test; detraining
Method of measurement
Sherer Self Efficacy Scale

7

Description
Psychological Well-being
Timepoint
Pre test; mid test 1; mid test 2; post test; detraining
Method of measurement
Ryff’s Psychological Well-being Scales

8

Description
Sleep Quality and Quantity
Timepoint
Pre test; mid test 1; mid test 2; post test; detraining
Method of measurement
Sleep quality assessment(PSQI) and Sleep Duration

9

Description
Spiritual Health
Timepoint
Pre test; mid test 1; mid test 2; post test; detraining
Method of measurement
Ellison & Palutzian Spiritual Health

Intervention groups

1

Description
The experimental groups participated 3 sessions per week for 12 weeks based on the training schedule with defined severity and duration (according to the standard protocol). Control group received no intervention.
Category
Prevention

2

Description
Control group received no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
SINA Hospital
Full name of responsible person
Mr Hashemi
Street address
SINA Hospital, Azadi Blvd
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Tabriz
Full name of responsible person
Eskandar Fathiazar
Street address
Floor 2, Central Bldg, Jame Jam St, 29 Blvd, University of Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Tabriz
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Vice chancellor for research, University of Mohaghegh Ardabili
Full name of responsible person
Mohamad Narimani
Street address
University of Mohaghegh Ardabili, Central Bldg, Daneshgah St
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Mohaghegh Ardabili
Proportion provided by this source
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
University of Mohaghegh Ardabili, University of Tabriz
Full name of responsible person
Elaheh Piralaiy
Position
Ph.D Student
Other areas of specialty/work
Street address
University of Tabriz, Faculty of Physical Education and Sport Sciences, Jame Jam St, 29 Blvd
City
Tabriz
Postal code
516661647
Phone
+98 413393258
Fax
Email
epiralaiy@tabrizu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Mohaghegh Ardabili, University of Tabriz
Full name of responsible person
Elaheh Piralaiy
Position
Ph.D Student
Other areas of specialty/work
Street address
University of Tabriz, Faculty of Physical Education and Sport Sciences, Jame Jam St, 29 Blvd
City
Tabriz
Postal code
516661647
Phone
+98 413393258
Fax
Email
epiralaiy@tabrizu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahar Branch, Islamic Azad University
Full name of responsible person
Mahboub Sheikhalizadeh
Position
Ph.D, Academic Member
Other areas of specialty/work
Street address
Floor 2, Bldg 4, Ostadan Residenial Complex, University of Tabriz, Jame Jam St, 29 Blvd
City
Tabriz
Postal code
516661647
Phone
+98 41 3331 1696
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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