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Comparison of the effect of three types of aerobic, resistance, and topical specialized exercises on glycemic indexes and neuropathy in diabetic patients

Protocol summary

Study aim
Comparison of the effect of three types of aerobic, resistive, and localized exercises on glycemic indexes and neuropathy in diabetic patients
Design
The clinical trial with three intervention groups, pragmatic, Single-blind, randomized
Settings and conduct
This study is conducted in the Diabetes Clinic of Vasei Hospital in Sabzevar. The evaluator is unaware of the grouping. Patients are randomly assigned to the intervention group 1, 2 and 3. The response to treatment is evaluated using Neuron-EMG-Micro device, Michigan neuropathy questionnaires, ABI device, tuning fork at the end of the second month after intervention for all three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: FBS above 126 mg/dl; Having diabetes for 4-6 years. Exclusion criteria: Having autonomic neuropathy; non-diabetic neuropathy using drugs affecting the nervous and vascular systems; Having Cardiac or musculoskeletal problems precludes activity.
Intervention groups
Intervention group 1: Patients in this group perform resistance training for 8 weeks and 3 sessions per week including 10 minutes of warm-up, 40 minutes of core exercise, and 10 minutes of cool-down. Intervention group 2: Patients in this group perform aerobic exercises for 8 weeks and 3 sessions per week including 10 minutes warm-up, 45 minutes core exercise and 5 minutes cool-down. Intervention group3: Patients in this group perform specialized topical exercises in this group for 8 weeks and 5 days a week with a special protocol (flexion, extension, abduction, and adduction of hip and shoulder and flexion and extension of elbow and knee and little joints).
Main outcome variables
Fast Blood Sugar (FBS); Hemoglobin A1C(HbA1C); the severity of diabetic neuropathy; Limbs hypertension, sense of vibration; balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181006041252N19
Registration date: 2019-12-17, 1398/09/26
Registration timing: retrospective

Last update: 2019-12-17, 1398/09/26
Update count: 0
Registration date
2019-12-17, 1398/09/26
Registrant information
Name
Mohammad Sahebkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 8337
Email address
sahebkarm@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-14, 1398/01/25
Expected recruitment end date
2019-12-16, 1398/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of three types of aerobic, resistance, and topical specialized exercises on glycemic indexes and neuropathy in diabetic patients
Public title
The effect of three types of aerobic, resistance, and topical specialized exercises in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FBS above 126 mg/dl or 2h blood glucose above 200 mg/dl Diabetic neuropathy Having diabetes for 4-6 years History of Metformin use for at least 2 years Start medication for diabetes
Exclusion criteria:
Having autonomic neuropathy, non-diabetic neuropathy Using drugs affecting the nervous and vascular systems Having Cardiac or musculoskeletal problems precludes activity
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is conducted based on a permutation block, Accordingly, 9 blocks were allocated to patients, in each block, 3 were from the following treatment groups A, B, and C. Eventually, after completion of the blocks, group A undergoes resistance training, group B undergoes aerobic training and group C undergoes topical specialized training.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person in the study will be assigned to the code 'A', 'B' or 'C' . only outcome assessor is unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.MEDSAB.REC.1397.127

Health conditions studied

1

Description of health condition studied
Diabetic neuropathy
ICD-10 code
E08.40
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

Primary outcomes

1

Description
Fasting blood sugar (FBS).
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Use of Luminescence quantitative and ELISA methods.

2

Description
Hemoglobin A1C
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Use of Luminescence quantitative and ELISA methods.

3

Description
The severity of diabetic neuropathy
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Use of the Michigan Neuropathy Screening Instrument (MNSI).

Secondary outcomes

1

Description
The limbs blood flow
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Ankle-Brachial Index (ABI) device

2

Description
Dynamic equilibrium
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Neuron-EMG-Micro device

3

Description
The sense of vibration
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Tuning fork device

4

Description
The sense of touch
Timepoint
At the beginning of the study (before the intervention) and 2 months after the start of the training program.
Method of measurement
Round bottom pin, cotton or brush

Intervention groups

1

Description
The first Intervention group: Patients in this group perform resistance training for 8 weeks and 3 sessions per week including 10 minutes of warm-up, 40 minutes of core exercise, and 10 minutes of cool-down.
Category
Treatment - Other

2

Description
The second intervention group : Patients in this group perform aerobic exercises for 8 weeks and 3 sessions per week including 10 minutes warm-up, 45 minutes core exercise and 5 minutes cool-down.
Category
Treatment - Other

3

Description
The third intervention group: Patients in this group perform specialized topical exercises in this group for 8 weeks and 5 days a week with a special protocol (flexion, extension, abduction, and adduction of hip and shoulder and flexion and extension of elbow and knee and little joints).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasei hospital
Full name of responsible person
Mohammad Sahebkar
Street address
Vasei Hospital, Asadabady Ave., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 8337
Email
vasei.h@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
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
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Sahebkar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Fax
Email
Mohammad.sahebkar66@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Hamid Marefati
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Fax
Email
h.marefati@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Mohammad Sahebkar
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8337
Fax
Email
Mohammad.sahebkar66@yahoo.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
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