The Comparison of Eeffect of Aerobic and Combined Exercise Training on Functional Indicators and some cardiovascular risk factors in lower-limb amputee
Comparison of the effect of aerobic and combined exercises on cardiovascular function and some cardiovascular risk factors in male lower limb amputation.
Design
The clinical trial has a control group, with two aerobic groups and a single-strain combination, randomized, on 45 lower limb amputation veterans. Randomization is done by block method and by an assistant outside the research.
Settings and conduct
The experimental groups receive the intervention related to them for 12 weeks at the Isar Hall in Shahrekord. The control group continues their usual activities during 12 weeks. The subjects are blinded to the grouping and the training sessions of the groups are done on different days.
Participants/Inclusion and exclusion criteria
Inclusion criteria included male gender, veterans 50-70%, age group 45-60 years, lower limb amputation, no history of metabolic disease and no smoking. Also, exclusion criteria include infectious diseases such as influenza and covid-19, non-participation in exercises,and use of anti-inflammatory drugs.
Intervention groups
The control group continues their usual activities during 12 weeks. Aerobic group exercises including 12 weeks of exercises will be done in 3 sessions per week. Exercises start in the first week with an intensity of 40% of the maximum heart rate and finally reach 70% of the maximum heart rate in the twelfth week. Combined group exercises include aerobic and resistance exercises for 12 weeks, 3 sessions per week. In the first week, resistance training starts as 2 sets with 8-12 repetitions and with 40% of 1 repetition maximum, and in the twelfth week it reaches 4 sets with 6-8 repetitions and with an intensity of 70% of 1 repetition maximum.
The Comparison of Eeffect of Aerobic and Combined Exercise Training on Functional Indicators and some cardiovascular risk factors in lower-limb amputee
Public title
Comparison of the effect of 12 weeks of aerobic and combined training based on performance indicators and some other cardiovascular risk factors affected by amputation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Lower extremity amputation veteran
Written consent to enter the research
Do not have a history of regular sports activities
Have no history of advanced metabolic disease
Do not smoke
Age 45 to 60 years old
Being male
Exclusion criteria:
Veterans of upper limb amputation and spinal cord amputation
Having a regular sports record
Having advanced metabolic disease
smoking
Infectious diseases such as influenza and covid
Failure to participate in training
Age
From 45 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After the announcement of the call and examination of the medical files, the candidates are enrolled in the study, and after the examination, based on the criteria of entry and exit from the study, 45 veterans of lower body amputations are selected as a sample. 45 samples are selected through available sampling and randomly divided into one of 3 groups: aerobic training (15 people), combined training (15 people) and control (15 people). Randomization is done by block method and by an assistant outside the research. In this way, the samples are randomized in the form of 3:3:3 blocks in each of the studied groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects are blinded to the grouping and the training sessions of the groups are done on different days.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Najaf Abad branch
Street address
Arghavan Street
City
Najafabad
Province
Isfehan
Postal code
8514143131
Approval date
2020-09-09, 1399/06/19
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1400.048
Health conditions studied
1
Description of health condition studied
Lower limb amputation veterans
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improvement of C-reactive protein level in the blood of lower limb amputees due to exercise.due to exercise
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood tests
2
Description
Improving the level of interleukin-6 in the blood of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood tests
3
Description
Improving the level of v-cam in the blood of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood tests
4
Description
Improving blood ESR levels of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood tests
5
Description
Improving the fasting blood sugar level of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood tests
6
Description
Improvement of systolic blood pressure of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training, the individual's resting blood pressure is taken.
Method of measurement
Manometer
7
Description
Improvement of diastolic blood pressure of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training, the individual's resting blood pressure is taken.
Method of measurement
Manometer
8
Description
Improving the red blood cell sedimentation rate of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
9
Description
Lowering blood cholesterol levels of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
10
Description
Reducing the level of low-density lipoprotein cholesterol in the blood of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
11
Description
Increasing the level of high-density lipoprotein cholesterol in the blood of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
12
Description
Reducing blood triglyceride levels of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
13
Description
Improvement of blood alanine aminotransferase levels of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
14
Description
Reduction of aspartate aminotransferase levels in the blood of lower limb amputees due to aerobic and combined exercise.
Timepoint
24 hours before the start of the study and 24 hours after 12 weeks of aerobic and combined training at rest and after 10 hours of overnight fasting, the initial blood sample of 10 cc will be taken from the frontal vein of the subjects.
Method of measurement
Blood test
15
Description
Improvement of the end-systolic and diastolic inner diameter of the heart due to aerobic and combined exercise.
Timepoint
24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after choosing the most suitable image of the heart chambers in the resting state, the end-diastolic and systolic diameters (mm) were measured by one-dimensional method. will be
Method of measurement
Echocardiography device
16
Description
Improvement of left ventricular ejection fraction due to aerobic and combined exercise.
Timepoint
24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side. After selecting the most appropriate image of the heart chambers in the resting state, the variables of the ejection fraction (percentage) are measured by the one-dimensional method.
Method of measurement
Echocardiography device
17
Description
Improving the thickness of the interventricular wall of the heart due to aerobic and combined exercise.
Timepoint
24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after choosing the most appropriate image of the heart chambers in the resting state, varying the thickness of the interventricular septum (mm) with a one-dimensional measurement method.
Method of measurement
Echocardiography device
18
Description
Improving the thickness of the posterior wall of the left ventricle of the heart as a result of aerobic and combined exercise.
Timepoint
24 hours before the start of the first exercise and 24 hours after the last exercise, each subject was asked to lie on his left side after selecting the most suitable image of the heart chambers in the resting state, varying the thickness of the posterior wall of the left ventricle (mm) with a one-dimensional method. will be measured.
Method of measurement
Echocardiography device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aerobic exercise: Aerobic group exercises include 12 weeks of exercises, 3 sessions per week and each session is between 30 and 50 minutes and with increasing load. Each training session consists of three parts: warm-up, main training body and cool-down. Exercises start in the first week with an intensity of 40% of the maximum heart rate and finally reach 70% of the maximum heart rate in the twelfth week. Maximum heart rate measurement is evaluated using the formula (220-Sen). Also, the assessment of the heart rate of exercise using a polar hourly heart rate monitor.
Category
Prevention
2
Description
Intervention group: Combined exercise: Combined group exercises include aerobic and resistance exercises that are performed for 12 weeks, 3 sessions per week and each session between 30 and 60 minutes, with extra load. Each training session consists of three parts: warm-up, main training body and cool-down. The aerobic part of the exercises is performed in the same way as the aerobic exercise group, but with half the time of the aerobic exercise group. The resistance exercises section includes resistance exercises for the upper body with equipment and free weights for the main and large muscle groups of the upper body (head, forearm, chest, armpit, back of the arm, abdomen). Resistance exercises in the first week in 2 sets with 8-12 repetitions
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Azad University, Najaf Abad branch
Full name of responsible person
Maliheh Heydari
Street address
Najafabad branch, Islamic Azad University, Daneshgah Boulevard
City
Najaf Abad
Province
Isfehan
Postal code
851414433131
Phone
+98 31 4229 1111
Fax
+98 31 4229 1016
Email
ict@iaun.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Najaf Abadَ Islamic Azad University
Full name of responsible person
dr. Mehdi Rafiei
Street address
Najafabad branch, Islamic Azad University, Daneshgah Boulevard
City
Najaf Abad
Province
Isfehan
Postal code
85141433131
Phone
+98 31 4229 2305
Email
info @ iaun.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Najaf Abadَ Islamic Azad University
Proportion provided by this source
5
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
Najafabad Azad University
Full name of responsible person
Maliheh Heydari
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Exercise Cardiovascular Physiology and Respiration
Street address
Isfahan, Najaf Abad, University Boulevard, Najaf Abad Azad University
City
Najaf Abad
Province
Isfehan
Postal code
8514143131۸۵۱
Phone
+98 31 4229 2929
Email
info @ iaun.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Najaf Abad branch
Full name of responsible person
Maliheh Heydari
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Cardiovascular physiology
Street address
Najafabad branch, Islamic Azad University, Daneshgah Boulevard
City
Najaf Abad
Province
Isfehan
Postal code
8514143131
Phone
+98 31 4229 2929
Email
ict@iaun.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Najafabad Azad University
Full name of responsible person
Maliheh Heydari
Position
Teacher
Latest degree
Master
Other areas of specialty/work
Cardiovascular physiology
Street address
Najafabad branch, Islamic Azad University, Daneshgah Boulevard
City
Najaf Abad
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8514143131
Phone
+98 31 4229 2929
Email
info @ iaun.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available