Determination of the effect of a period of aerobic and resistance training on sarcopenia indices in diabetic patients
Design
The clinical trial with two groups (intervention 1 and 2), pragmatic, single-blind, randomized.
Settings and conduct
This study is conducted to compare the effect of two types of aerobic and resistive exercises on sarcopenia indexes in diabetic patients the Diabetes Clinic of Vasei Hospital of Sabzevar. The evaluator is unaware of the grouping. Patients are randomized in the intervention group 1 and 2. The response to treatment is evaluated using sarcopenia indices at the end of the second month after intervention for both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 40 and 70 years, Patients with low physical activity based on Global Physical Activity. Questionnaire. (GPAQ) standard questionnaire, Metformin consumption for at least 2 years, Having diabetes for 4-6 years.
Exclusion criteria: Patients with a high blood glucose of 250 mg/dl, Having cardiac or musculoskeletal problems precludes activity, Using drugs affecting the nervous and vascular systems.
Intervention groups
Intervention group 1: Patients in this group perform resistance training for 8 weeks and 3 sessions per week including 10 minutes warm-up, 40 minutes core exercise and 10 minutes cool-down.
Intervention group 2: Patients in this group perform aerobic exercise for 8 weeks and 3 sessions per week including 10 minutes warm-up, 45 minutes core exercise and 5 minutes cool-down.
Main outcome variables
Determination of testosterone, sarcopenia index, and waist to hip ratio (WHR).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181006041252N17
Registration date:2019-12-01, 1398/09/10
Registration timing:registered_while_recruiting
Last update:2019-12-01, 1398/09/10
Update count:0
Registration date
2019-12-01, 1398/09/10
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 effects of two types of aerobic and resistance training on sarcopenia indexes (SI) in diabetic patients
Public title
Comparison of two types of aerobic and resistance training on on sarcopenia indexes (SI) in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with low physical activity based on GPAQ standard questionnaire
Metformin consumption for at least 2 years
Having diabetes for 4 to 6 years
Fasting blood glucose above 126 mg /dL
Age between 40 and 70 years
Exclusion criteria:
Patients with a high blood glucose of 250 mg/dl
Having cardiac or musculoskeletal problems precludes activity
Using drugs affecting the nervous and vascular systems
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted based on a permutation block by a statistical consultant using random allocation software and the output sequences A and B are available to the researcher, Accordingly,12 blocks were allocated to patients, in each block, 2 were from following groups, treatment group A and group B. Eventually, after completing the blocks, Group A and B were trained with resistance and aerobic exercises respectively. First, we determine all foursome modes in which half of the individuals are assigned to group A and the other half to group B. Then we assign one of the digits 1 to 6 to each of the foursome combinations (which includes six modes). In the next step, we must randomly select 20 blocks of four and write their combinations in succession. For this we have to make 20 samplings with replacement from a six-member community; 20 times, choose a random number between 1 and 6 and this process will continue until the end of the sampling and the difference between the two groups will not exceed a maximum of two (half the size of the block)
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person will be assigned a study code A and B, which will only be known to the researcher of the type of groups. The evaluator 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.1397.131
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Determine the level of testosterone
Timepoint
At the beginning of the study (before the intervention) and 2 months after the beginning of the training program.
Method of measurement
Use of Luminescence quantitative and ELISA methods.
2
Description
Determine Sarcopenia Index (SI)
Timepoint
At the beginning of the study (before the intervention) and 2 months after the beginning of the training program.
Method of measurement
(Serum Creatinine value/Cystatin C value) × 100. Use of Luminescence quantitative and ELISA methods to measure serum levels.
3
Description
Determination of Waist to hip ratio (WHR)
Timepoint
At the beginning of the study (before the intervention) and 2 months after the beginning of the training program.
Method of measurement
Use of meters
Secondary outcomes
1
Description
Determination of 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
Determination of 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
Determination of 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
Rub round bottom pin, cotton or brush
4
Description
Determination of 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
Use of Ankle-Brachial Index (ABI) device
5
Description
Determination of body mass index
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 standard meters and scales
Intervention groups
1
Description
Intervention group 1: Patients in this group perform resistance training for 8 weeks and 3 sessions per week including 10 minutes warm-up, 40 minutes core exercise and 10 minutes cool-down.
Category
Treatment - Other
2
Description
Intervention group 2: Patients in this group perform aerobic exercise 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
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
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 8337
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
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
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
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
Undecided - It is not yet known if there will be a plan to make this available