Investigating the effect of resistance training with elastic bands on cardiometabolic and functional factors of elderly diabetic women
Design
The clinical trial has an intervention group and a control group, with parallel groups, one-sided blind, randomized, on 30 elderly diabetic women. Sealed envelopes will be used for randomization.
Settings and conduct
Place of study: Kahrizak Charity Foundation in Karaj; Study population: elderly women with diabetes; Type of blinding: one-sided blind; Method of blinding: The laboratory technician who performs the biochemical analyzes is unaware of the grouping method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having general health; being in the age range of 65-80 years; suffering from type 2 diabetes with a history of more than two years based on fasting glucose > 126 mg/dL; 2-hour glucose > 200 mg/dL or HbA1c > 6.5%. Exclusion criteria: known acute cardiovascular disease; having special diets; or weight instability (±5 kg) in the past 3 months; and any serious medical condition that prohibits long-term participation in physical activity
Intervention groups
Intervention group: resistance exercise with elastic bands; Control group: will not receive any intervention
Investigating the effect of resistance training with elastic bands on cardiometabolic and functional factors of elderly diabetic women
Public title
The effect of exercise on elderly diabetic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Woman
Elderly
Having general health
Being in the age range of 65-80 years
Suffering from type 2 diabetes with a history of more than Two years
Fasting glucose more than 126 mg/dL
2-hour glucose more than 200 mg/dL
HbA1c level more than 6.5%
Exclusion criteria:
Insufficient physical ability
Insufficient awareness
Having psychological problems
Having acute cardiovascular diseases
Smoking and alcohol use
Lack of mobility
Using walkers and wheelchairs
Having a special diet
Weight instability in the last 3 months
Age
From 65 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Fifteen opaque, sealed envelopes each containing number 1 representing exercise group, and 15 similar envelopes each containing number 2 representing control group would be prepared. Next, a random number from 1 to 30 would be assigned to the envelopes. Based on order of patients entry into the study, the participants would be given a numbered envelope with the same random number.
Blinding (investigator's opinion)
Single blinded
Blinding description
The only desired intervention is exercise training. For the purpose of blinding, only the person who performs the biochemical measurements in the participants serum samples in the laboratory is blind to the grouping of the research so that no bias will occur in the presentation of the results.
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
2
Description
Adiponectin
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
3
Description
Physical fitness factor (strength)
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Functional tests
4
Description
Growth differentiation factor-15 (GDF15)
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
5
Description
Triglycerides
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
6
Description
Total cholesterol
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
7
Description
Low density lipoprotein
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
8
Description
High density lipoprotein
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
9
Description
Tumour necrosis factor alpha
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
10
Description
C-reactive protein
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
11
Description
Insulin
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
12
Description
Glucose
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Glucose oxidase method
13
Description
Insulin resistance
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Mathematical formula
14
Description
Glycosylated hemoglobin
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Through ELISA method in blood serum samples
15
Description
Physical fitness factor (balance)
Timepoint
At baseline and 48 hours after last session of training
Method of measurement
Functional test
Secondary outcomes
1
Description
Body composition
Timepoint
At baseline and 48 hours after the last training session
Method of measurement
Body composition device
2
Description
Blood plessure
Timepoint
At baseline and 48 hours after the last training session
Method of measurement
Germany Bearer digital blood pressure device
3
Description
Sleep quality
Timepoint
At baseline and 48 hours after the last training session
Method of measurement
Pittsburg Questionnaire
Intervention groups
1
Description
Intervention group: 12 weeks of resistance training with elastic bands (changing the color of the bands will be considered in order to increase the intensity of the training, which will be yellow-red-green-blue-black and silver, respectively)/ 3 training sessions per week and a total of 36 sessions/ each session lasts 45 minutes/ each session has a total of 6 movements and each movement will be performed in 3 sets and in 10-20 repetitions, with an index of perception of pressure based on the Borg scale equal to 10-13 RPE.
Category
Rehabilitation
2
Description
Control group: inactive
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kahrizak Charity Foundation
Full name of responsible person
Hasan Ahmadi
Street address
At tha begining of Esfahaniha street, at the end of Golestank street, Mohammadshahr
City
Karaj
Province
Alborz
Postal code
31845167
Phone
+98 26 3630 9171
Fax
+98 26 3630 1859
Email
Kahraj@kahrizak.com
Web page address
https://kahrizakcharity.com/#
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran National Science Foundation
Full name of responsible person
Ali Mohammad Soltani
Street address
No. 33, Fifth St., above Jalal Al Ahmad intersection, North Kargar St.
City
Tehran
Province
Tehran
Postal code
۱۴۳۹۶۳۴۶۶۵
Phone
+98 21 8216 1000
Fax
+98 21 8800 3981
Email
rms@insf.org
Web page address
https://insf.org/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran National Science Foundation
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
Kharazmi University
Full name of responsible person
hamid rajabi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Faculty of Sports Sciences of Kharazmi University, Shahid Keshvari Stadium, Shahid Hesari St., Mader Squ., Tehran
City
tehran
Province
Tehran
Postal code
1954812345
Phone
0098 21 88329220-3
Fax
Email
UMZ.kheradmand@gmail.com
Web page address
https://khu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hamid Rajabi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Faculty of Sports Sciences of Kharazmi University, Shahid Keshvari Stadium, Shahid Hesari St., Mader Square, Tehran
City
Tehran
Province
Tehran
Postal code
1954812345
Phone
0098 21 88329220-3
Fax
Email
hrajabi@khu.ac.ir
Web page address
https://pess.khu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hamid Rajabi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
exercise physiology
Street address
Faculty of Sports Sciences of Kharazmi University, Shahid Keshvari Stadium, Shahid Hesari St., Mader Square, Tehran
City
Tehran
Province
Tehran
Postal code
1954812345
Phone
0098 21 88329220-3
Fax
Email
hrajabi@khu.ac.ir
Web page address
https://pess.khu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information".
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
NO
When the data will become available and for how long
Data is not published.
To whom data/document is available
Data is not published.
Under which criteria data/document could be used
Data is not published.
From where data/document is obtainable
Data is not published.
What processes are involved for a request to access data/document