Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627881
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Effect of Three Training Programs on the Cardiovascular Condition of Individuals with Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Three Training Programs on the Cardiovascular Condition of Individuals with Spinal Cord Injury a Model of Autonomic Nervous System Dysfunction
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective Describe the effect of different aerobic training programs on the autonomic nervous system ANS cardiovascular condition body composition metabolic profile movement and functional independence in patients with spinal cord injury SCI
Design Randomized clinical trial Participants Individuals in the chronic phase of SCI Interventions Three training programs continuous aerobic in kayak aerobic resistance circuit and high-intensity interval with rope The main measures to be explored will be the potential effects of training on heart rate variability as an indicator of autonomic function measurement of oxygen consumption VO2max and resting metabolic unit METs for cardiovascular fitness bone density examination DXA for body composition metabolic profile functional independence and life satisfaction in individuals with SCI
Results The 8-week training program will increase METs and VO2max improve heart rate variability and anthropometric variables body composition and metabolic profile
Design Randomized clinical trial Participants Individuals in the chronic phase of SCI Interventions Three training programs continuous aerobic in kayak aerobic resistance circuit and high-intensity interval with rope The main measures to be explored will be the potential effects of training on heart rate variability as an indicator of autonomic function measurement of oxygen consumption VO2max and resting metabolic unit METs for cardiovascular fitness bone density examination DXA for body composition metabolic profile functional independence and life satisfaction in individuals with SCI
Results The 8-week training program will increase METs and VO2max improve heart rate variability and anthropometric variables body composition and metabolic profile
Detailed Description:
Background The increased overall cardiovascular risk could have some causes such as dyslipidemia diabetes mellitus hypertension HTN higher BMI higher waist-to-hip ratio or deterioration in physical fitness Obesity and diabetes have been shown to be comparatively higher among people with SCI An additional factor that contributes to the high cardiovascular morbidity and mortality in SCI is sedentary lifestyle and reduced physical function associated with the loss of motor function and the interruption of normal autonomic cardiovascular control mechanisms
It is increasingly recognized that inflammation plays an important role in the development of cardiovascular disease CVD elevated reactive C protein RCP levels are independently associated with increased all-cause mortality cardiovascular death and cardiovascular events In turn the higher degree of dyslipidemia found in the population with SCI contributes significantly to this risk Abnormal lipids are generally modifiable with changes in physical activity and diet along with the use of statins Numerous studies in people with diabetes have unequivocally shown that hyperglycemia is a potent risk marker for CVD altered carbohydrate metabolism is more common in people with SCI and is believed to appear at an earlier age than in people without disabilities
High adiposity and visceral fat accumulation are related to insulin resistance gluco-metabolic disorders and a higher risk of developing DM diabetes mellitus and CVD Sophisticated and high-precision radiological techniques such as DXA and CT are considered the gold standards for accurate measurement of the ratio of lean to fat mass it is proposed that the increase in body fat mass and the decrease in Lean tissue mass are valuable markers of CVD
Exercise has been shown to have good results mainly in the early stages of BF In particular it has been described that aerobic exercise training improves baroreflex sensitivity and that the magnitude of the improvement is related to the intensity of the exercise performed and is proportional to the gains in aerobic capacity through VO2max However in advanced stages of CVD the response to exercise may be affected due to ANS dysfunction Indeed autonomic dysfunction plays a primary role in the pathophysiology of coronary ischemic disease The presence of a high HRV is a sign of good adaptability and implies that the individual has autonomic control mechanisms that function adequately that is the activity of this system plays a substantial role in the physiological adaptations of circulation to changes in brain activity human being Therefore the study of pathologies that affect the ANS can help understand this lack of response and search for effective strategies to improve cardiovascular function
To date there are few studies that have evaluated the effect of different exercise modalities on the cardiovascular condition of people with SCI who will have a different response from that of healthy people or at the beginning of chronic diseases but similar to that of people in advanced stages of cardiovascular disease Therefore exercise can exert cardioprotective effects and benefit the cardiovascular risk profile
Justification
A SCI is accompanied by alterations in the autonomic nervous system that lead to an increase in cardiovascular risk in the chronic stages after 6 months of the injury In view of the high prevalence of cardiovascular disease health consequences and costs associated with SCI greater emphasis should be placed on identifying therapeutic interventions that reduce cardiovascular risk factors
It is documented that intervention with low to moderate intensity aerobic exercise induces favorable adaptations in patients with chronic SCI and reduces cardiovascular risk
However individuals with SCI face physical impairments and psychological barriers that increase the challenge of implementing exercise into their daily lives Therefore prescribing and controlling exercise intensity presents its own difficulties particularly for people with an altered heart rate response to exercise
Knowing the effect of aerobic exercise in individuals with SCI will allow the implementation of a training program in a timely manner that will help prevent cardiovascular diseases It will also improve physical fitness levels which makes it easier to carry out activities of daily living and in turn improves quality of life
The National Rehabilitation Institute is a place of concentration for the care of people with SCI and each year approximately 250 first-time specialized consultations are granted to people with said diagnosis In addition there is a multidisciplinary team and the necessary infrastructure to carry out this project
Research question
What is the effect of three different aerobic training programs on cardiac autonomic system cardiovascular fitness body composition metabolic profile and independence in people with SCI
Hypothesis
The 8-week continuous aerobic kayak training program will increase METs and VO2max improve heart rate variability and anthropometric variables body composition metabolic profile muscle strength functional independence and life satisfaction significantly compared to aerobic resistance circuit exercise and high-intensity interval rope exercise
OBJECTIVES to General objective
Describe the effect of 3 different training programs continuous aerobic in kayak aerobic resistance circuit and high intensity interval with rope on the cardiac autonomic system cardiovascular fitness body composition metabolic profile and independence in individuals with injury medullary
Describe the correlation between the R-R interval VO2max METs and possible correlating factors such as age NLI AIS and chronicity of the injury
Clinical and demographic outcome measurements
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCIM III Spinal Cord Independence Measure Measurement of Functional Independence in spinal cord injuries
LiSAT-9 Life Satisfaction Scale
VO2max Oxygen consumption
METs Metabolic equivalents
STD RR Time domain measurement of cardiac variability
RMSSD Time domain measurement of cardiac variability
pNN50 Time domain measurement of cardiac variability
VLF Frequency domain measurement of very low frequency cardiac variability
LF Frequency domain measurement of low frequency cardiac variability
HF Frequency domain measurement of high frequency cardiac variability
LFHF Frequency domain measurement of cardiac variability
Serum glucose plasma glucose concentration
Triglycerides concentration of triglycerides in plasma
HDL cholesterol amount of cholesterol linked to high-density lipoproteins HDL-C
LDL cholesterol amount of cholesterol bound to low-density lipoproteins
Serum insulin hormone involved in the regulation of carbohydrate metabolism
Ultrasensitive PCR Acute phase reactant that is released in response to inflammatory processes
total body fat percentage of total body fat
Android fatty tissue
Android fat tissue percentage
Gynecoid fatty tissue Percentage of gynecoid fatty tissue
AG ratio Android fat tissuegynecoid fat tissue ratio
VAT mass Visceral adipose tissue
VAT Visceral adipose tissue volume
VAT visceral adipose tissue area
Appen lean height Relationship between appendicular lean mass and height ALMHeight2
Body mass index Weight of a person in kilograms divided by the square of height in meters in individuals with BF
Diet Adherence Percentage of subjects with diet adherence
Clinical trunk control test Ability to perform different activities related to balance and trunk movement
Instrumented Trunk Control Test Trunk stability evaluated using inertial measurement units IMUs
Max Torque Ext Maximum force generated by a muscle or muscle group during a concentric contraction in the extension phase of a specific joint
Torque max Flex Maximum force generated by a muscle or muscle group during a concentric contraction in the flexion phase of a specific joint
Maximum power Ext Rate of work done or the amount of energy generated per unit of time in a muscle group during a concentric contraction in the extension phase of a specific joint in an isokinesia test
Maximum Flex Power Rate of work performed or the amount of energy generated per unit of time in a muscle group during a concentric contraction in the Flexion phase of a specific joint in an isokinesia test
Total Work Ext Amount of energy transferred or performed by a force when applied over a distance during an Extension exercise
Total Work Flex Amount of energy transferred or performed by a force when applied over a distance during a Flexion exercise
DESIGN AND METHODOLOGY Type of study Randomized clinical trial RCT Description of the work universe Patients from the outpatient clinic and hospitalization of the Spinal Injury service of the National Rehabilitation Institute with a diagnosis of spinal cord injury of any etiology any type complete and incomplete with neurological level below C8 of more than 6 months of evolution
Inclusion Criteria
Age over 18 years
Any sex
Spinal cord injury due to any etiology
With clinical diagnosis of spinal cord injury of any type complete and incomplete
With a clinical diagnosis of spinal cord injury with a neurological level below C8 who are able to lift orand grab the paddle ropes resistance bands or weights
With evolution time greater than 6 months
Adequate trunk control trunk control scale 13 points
That you have a letter of informed consent
Elimination criteria
That another cardiovascular pathology be added
Sample size A previous INRLGII study found an effect size of 126 with a standard deviation of 36 with kayak ergometer training compared to conventional therapy With the Epidata 42 program the sample was calculated with the hypothesis contrast method with comparison of means for independent groups In order to achieve an effect size with a confidence level that was set at 95 corresponding to an alpha value of 005 and a power of 80 6 patients per group are required and considering 20 losses we will recruit 8 patients per group group with a total of 24 patients
Randomization Study participants will be randomly assigned to one of the 3 exercise programs using a computer-generated hidden block randomization scheme with Epidata software with randomly varying blocks and stratification by sex female or male age male or female 18 to 44 45 to 70 years and AIS score A B C or D Participants will be assigned to their respective intervention according to the randomization schedule Participants will be assigned a randomization number in the order they enroll
Blinding Those in charge of evaluating results and the person in charge of statistical analysis will be blinded and will not know the assignment of the intervention The person in charge of carrying out the assigned exercise and the participant will know the assignment of the intervention
Results analysis plan For the analysis a descriptive analysis is first proposed using measures of central tendency and dispersion for the quantitative variables and proportions for the qualitative variables Analysis of variance will be performed to compare baseline characteristics between groups
To know the distribution of the data the Kolmogorov-Smirnov test will be carried out Analysis of variance will be performed to compare the outcome measures at the end of training between the three groups
It is increasingly recognized that inflammation plays an important role in the development of cardiovascular disease CVD elevated reactive C protein RCP levels are independently associated with increased all-cause mortality cardiovascular death and cardiovascular events In turn the higher degree of dyslipidemia found in the population with SCI contributes significantly to this risk Abnormal lipids are generally modifiable with changes in physical activity and diet along with the use of statins Numerous studies in people with diabetes have unequivocally shown that hyperglycemia is a potent risk marker for CVD altered carbohydrate metabolism is more common in people with SCI and is believed to appear at an earlier age than in people without disabilities
High adiposity and visceral fat accumulation are related to insulin resistance gluco-metabolic disorders and a higher risk of developing DM diabetes mellitus and CVD Sophisticated and high-precision radiological techniques such as DXA and CT are considered the gold standards for accurate measurement of the ratio of lean to fat mass it is proposed that the increase in body fat mass and the decrease in Lean tissue mass are valuable markers of CVD
Exercise has been shown to have good results mainly in the early stages of BF In particular it has been described that aerobic exercise training improves baroreflex sensitivity and that the magnitude of the improvement is related to the intensity of the exercise performed and is proportional to the gains in aerobic capacity through VO2max However in advanced stages of CVD the response to exercise may be affected due to ANS dysfunction Indeed autonomic dysfunction plays a primary role in the pathophysiology of coronary ischemic disease The presence of a high HRV is a sign of good adaptability and implies that the individual has autonomic control mechanisms that function adequately that is the activity of this system plays a substantial role in the physiological adaptations of circulation to changes in brain activity human being Therefore the study of pathologies that affect the ANS can help understand this lack of response and search for effective strategies to improve cardiovascular function
To date there are few studies that have evaluated the effect of different exercise modalities on the cardiovascular condition of people with SCI who will have a different response from that of healthy people or at the beginning of chronic diseases but similar to that of people in advanced stages of cardiovascular disease Therefore exercise can exert cardioprotective effects and benefit the cardiovascular risk profile
Justification
A SCI is accompanied by alterations in the autonomic nervous system that lead to an increase in cardiovascular risk in the chronic stages after 6 months of the injury In view of the high prevalence of cardiovascular disease health consequences and costs associated with SCI greater emphasis should be placed on identifying therapeutic interventions that reduce cardiovascular risk factors
It is documented that intervention with low to moderate intensity aerobic exercise induces favorable adaptations in patients with chronic SCI and reduces cardiovascular risk
However individuals with SCI face physical impairments and psychological barriers that increase the challenge of implementing exercise into their daily lives Therefore prescribing and controlling exercise intensity presents its own difficulties particularly for people with an altered heart rate response to exercise
Knowing the effect of aerobic exercise in individuals with SCI will allow the implementation of a training program in a timely manner that will help prevent cardiovascular diseases It will also improve physical fitness levels which makes it easier to carry out activities of daily living and in turn improves quality of life
The National Rehabilitation Institute is a place of concentration for the care of people with SCI and each year approximately 250 first-time specialized consultations are granted to people with said diagnosis In addition there is a multidisciplinary team and the necessary infrastructure to carry out this project
Research question
What is the effect of three different aerobic training programs on cardiac autonomic system cardiovascular fitness body composition metabolic profile and independence in people with SCI
Hypothesis
The 8-week continuous aerobic kayak training program will increase METs and VO2max improve heart rate variability and anthropometric variables body composition metabolic profile muscle strength functional independence and life satisfaction significantly compared to aerobic resistance circuit exercise and high-intensity interval rope exercise
OBJECTIVES to General objective
Describe the effect of 3 different training programs continuous aerobic in kayak aerobic resistance circuit and high intensity interval with rope on the cardiac autonomic system cardiovascular fitness body composition metabolic profile and independence in individuals with injury medullary
Describe the correlation between the R-R interval VO2max METs and possible correlating factors such as age NLI AIS and chronicity of the injury
Clinical and demographic outcome measurements
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCI severity According to American Spinal Injury Association with International standards for neurological classification of spinal cord injury modifications complete B incomplete preservation of only the sensitive function C incomplete voluntary anal contraction or more than half of key muscles in 3 D incomplete more than half of the key muscles in 3 E total recuperation A B C D E Neurological level More caudal segment of the SC with normal function Time of evolution of the SCITime in days elapsed from when the SCI was produced until time of application of the questionnaire AgeYears elapsed from date of birth to time of questionnaire application
SCIM III Spinal Cord Independence Measure Measurement of Functional Independence in spinal cord injuries
LiSAT-9 Life Satisfaction Scale
VO2max Oxygen consumption
METs Metabolic equivalents
STD RR Time domain measurement of cardiac variability
RMSSD Time domain measurement of cardiac variability
pNN50 Time domain measurement of cardiac variability
VLF Frequency domain measurement of very low frequency cardiac variability
LF Frequency domain measurement of low frequency cardiac variability
HF Frequency domain measurement of high frequency cardiac variability
LFHF Frequency domain measurement of cardiac variability
Serum glucose plasma glucose concentration
Triglycerides concentration of triglycerides in plasma
HDL cholesterol amount of cholesterol linked to high-density lipoproteins HDL-C
LDL cholesterol amount of cholesterol bound to low-density lipoproteins
Serum insulin hormone involved in the regulation of carbohydrate metabolism
Ultrasensitive PCR Acute phase reactant that is released in response to inflammatory processes
total body fat percentage of total body fat
Android fatty tissue
Android fat tissue percentage
Gynecoid fatty tissue Percentage of gynecoid fatty tissue
AG ratio Android fat tissuegynecoid fat tissue ratio
VAT mass Visceral adipose tissue
VAT Visceral adipose tissue volume
VAT visceral adipose tissue area
Appen lean height Relationship between appendicular lean mass and height ALMHeight2
Body mass index Weight of a person in kilograms divided by the square of height in meters in individuals with BF
Diet Adherence Percentage of subjects with diet adherence
Clinical trunk control test Ability to perform different activities related to balance and trunk movement
Instrumented Trunk Control Test Trunk stability evaluated using inertial measurement units IMUs
Max Torque Ext Maximum force generated by a muscle or muscle group during a concentric contraction in the extension phase of a specific joint
Torque max Flex Maximum force generated by a muscle or muscle group during a concentric contraction in the flexion phase of a specific joint
Maximum power Ext Rate of work done or the amount of energy generated per unit of time in a muscle group during a concentric contraction in the extension phase of a specific joint in an isokinesia test
Maximum Flex Power Rate of work performed or the amount of energy generated per unit of time in a muscle group during a concentric contraction in the Flexion phase of a specific joint in an isokinesia test
Total Work Ext Amount of energy transferred or performed by a force when applied over a distance during an Extension exercise
Total Work Flex Amount of energy transferred or performed by a force when applied over a distance during a Flexion exercise
DESIGN AND METHODOLOGY Type of study Randomized clinical trial RCT Description of the work universe Patients from the outpatient clinic and hospitalization of the Spinal Injury service of the National Rehabilitation Institute with a diagnosis of spinal cord injury of any etiology any type complete and incomplete with neurological level below C8 of more than 6 months of evolution
Inclusion Criteria
Age over 18 years
Any sex
Spinal cord injury due to any etiology
With clinical diagnosis of spinal cord injury of any type complete and incomplete
With a clinical diagnosis of spinal cord injury with a neurological level below C8 who are able to lift orand grab the paddle ropes resistance bands or weights
With evolution time greater than 6 months
Adequate trunk control trunk control scale 13 points
That you have a letter of informed consent
Elimination criteria
That another cardiovascular pathology be added
Sample size A previous INRLGII study found an effect size of 126 with a standard deviation of 36 with kayak ergometer training compared to conventional therapy With the Epidata 42 program the sample was calculated with the hypothesis contrast method with comparison of means for independent groups In order to achieve an effect size with a confidence level that was set at 95 corresponding to an alpha value of 005 and a power of 80 6 patients per group are required and considering 20 losses we will recruit 8 patients per group group with a total of 24 patients
Randomization Study participants will be randomly assigned to one of the 3 exercise programs using a computer-generated hidden block randomization scheme with Epidata software with randomly varying blocks and stratification by sex female or male age male or female 18 to 44 45 to 70 years and AIS score A B C or D Participants will be assigned to their respective intervention according to the randomization schedule Participants will be assigned a randomization number in the order they enroll
Blinding Those in charge of evaluating results and the person in charge of statistical analysis will be blinded and will not know the assignment of the intervention The person in charge of carrying out the assigned exercise and the participant will know the assignment of the intervention
Results analysis plan For the analysis a descriptive analysis is first proposed using measures of central tendency and dispersion for the quantitative variables and proportions for the qualitative variables Analysis of variance will be performed to compare baseline characteristics between groups
To know the distribution of the data the Kolmogorov-Smirnov test will be carried out Analysis of variance will be performed to compare the outcome measures at the end of training between the three groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None