Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367296
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-02
Brief Title:
Resistance Exercise Training in the Older Population With Obesity
Sponsor:
Universidad de La Frontera
Organization:
Universidad de La Frontera
Study Overview
Official Title:
Effects of a Resistance Exercise Training Program on Skeletal Muscle Quality Immune Response and Physical Performance in Normal Weight Versus Obesity Older Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RETOPO
Brief Summary:
Background
Aging leads to an alteration in the immune response characterized by a chronic inflammatory state and a progressive decrease in muscle quantity and quality a situation that increases in women and in the presence of obesity With respect to muscle quality intramuscular infiltration of adipose tissue has been considered a relevant parameter involved in the relationship between aging-obesity-inflammation As a therapeutic strategy physical training with resistance exercises or also known as strength training has been shown to be effective in increasing skeletal muscle mass in this age group However its role on muscle quality in normal-weight versus obese older women has not been fully addressed
Hypothesis
A 12-week resistance exercise training program is effective in improving muscle quality immune response and physical performance in normal weight and obese older women In addition to the above the investigators hypothesize that women with obesity will present greater baseline alterations so the percentage of change will be higher compared to older women with normal weight after the training program
Goals
The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality infiltration of intramuscular adipose tissue immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range
Methodology
The present clinical trial will consider 2 groups of older women between 60 and 79 years old normal weight BMI185 to 249 kgm 2 and fat 259 and obese BMI 30 to 399 Kgm 2 and fat 32 Participants will perform 12 weeks of training with resistance exercises 3 times a week Before and after training intramuscular infiltration of adipose tissue echogenicity will be measured by ultrasound followed by aspects of muscle architecture muscle thickness penile angle and fascicle length and functional parameters of muscle quality maximum strength determined by 1 repetition maximum-1RM maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer Finally fasting blood samples will be obtained immune response and physical performance body composition physical activity level and quality of life will be evaluated
Aging leads to an alteration in the immune response characterized by a chronic inflammatory state and a progressive decrease in muscle quantity and quality a situation that increases in women and in the presence of obesity With respect to muscle quality intramuscular infiltration of adipose tissue has been considered a relevant parameter involved in the relationship between aging-obesity-inflammation As a therapeutic strategy physical training with resistance exercises or also known as strength training has been shown to be effective in increasing skeletal muscle mass in this age group However its role on muscle quality in normal-weight versus obese older women has not been fully addressed
Hypothesis
A 12-week resistance exercise training program is effective in improving muscle quality immune response and physical performance in normal weight and obese older women In addition to the above the investigators hypothesize that women with obesity will present greater baseline alterations so the percentage of change will be higher compared to older women with normal weight after the training program
Goals
The primary aim of this study is to evaluate the effects of a 12-week resistance exercise training on muscle quality infiltration of intramuscular adipose tissue immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range
Methodology
The present clinical trial will consider 2 groups of older women between 60 and 79 years old normal weight BMI185 to 249 kgm 2 and fat 259 and obese BMI 30 to 399 Kgm 2 and fat 32 Participants will perform 12 weeks of training with resistance exercises 3 times a week Before and after training intramuscular infiltration of adipose tissue echogenicity will be measured by ultrasound followed by aspects of muscle architecture muscle thickness penile angle and fascicle length and functional parameters of muscle quality maximum strength determined by 1 repetition maximum-1RM maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer Finally fasting blood samples will be obtained immune response and physical performance body composition physical activity level and quality of life will be evaluated
Detailed Description:
Background
Aging leads to an alteration in the immune response characterized by a chronic inflammatory state and a progressive decrease in muscle quantity and quality a situation that increases in women and in the presence of obesity With respect to muscle quality intramuscular infiltration of adipose tissue has been considered a relevant parameter involved in the relationship between aging-obesity-inflammation As a therapeutic strategy physical training with resistance exercises or also known as strength training has been shown to be effective in increasing skeletal muscle mass in this age group However its role on muscle quality in normal-weight versus obese older women has not been fully addressed
Hypothesis
A 12-week resistance exercise training program is effective in improving muscle quality immune response and physical performance in normal weight and obese older women In addition to the above the investigators hypothesize that women with obesity will present greater baseline alterations so the percentage of change will be higher compared to older women with normal weight after the training program
Goals
The primary aim of this study is evaluate the effects of a 12-week resistance exercise training on muscle quality infiltration of intramuscular adipose tissue immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range
Specific goals
To evaluate the effects of a 12-week resistance exercise training program in elderly women between 60 and 79 years of age with obesity in comparison to older people with normal weight of the same age range on parameters of
Muscle architecture muscle thickness pennation angle and fascicle length and muscle quality functionalities power and strength
Immune response through inflammatory cytokines Tumor necrosis factor a TNFa interleukin-1 IL-1 IL-6 IL-8 and induction of neutrophil extracellular traps NETosis
Physical performance SPPB Body composition BIA and quality of life SF-36
Methodology
The present clinical trial will consider 2 study groups of older women between 60 and 79 years old normal weight BMI185 to 249 kgm 2 and fat 259 and obese BMI 30 to 399 Kgm 2 and fat 32 Participants will perform 12 weeks of training with resistance exercises 3 times a week Before and after training intramuscular infiltration of adipose tissue echogenicity will be measured by ultrasound followed by aspects of muscle architecture muscle thickness penile angle and fascicle length and functional parameters of muscle quality maximum strength determined by 1 repetition maximum-1RM maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer Finally fasting blood samples will be obtained immune response and physical performance body composition physical activity level and quality of life will be evaluated
Study parametersendpoints
The main study endpoint is the decrease in echointensity as a marker of muscle quality evaluated through ultrasonography in the quadriceps muscles of the lower limbs of participants subjected to 12 weeks of resistance training
Secondary endpoints include Muscle architecture parameter morphological aspects of muscle quality muscle thickness pennation angle and fascicle length Functional parameters of muscle quality maximum voluntary isometric strength of knee extensors and lower limb power Immune response in blood TNFa IL-1 IL-6 IL-8 and NETosis Physical performance SPPB evaluation of maximum strength 1RM and handgrip strength Body composition fat mass and total muscle mass and for each lower limb and anthropometry waist - hip thigh and calf circumference leg length and knee height And Level of physical activity IPAQ and Quality of Life SF-36
Other study parameters include Age body weight body height body mass index BMI lipid profile glucose insulin HOMA index blood pressure heart rate and perception of effort using the Borg scale
Expected results
The effect of resistance exercise training on muscle quality in normal-weight versus obese older women is still unclear The present research project aims to demonstrate the effectiveness of this training modality in improving muscle quality parameters as well as measures of immune response and physical performance in older women However the investigators believe that the impact will be greater in women with obesity as they present greater baseline alterations compared to older normal weight women The possible findings will define the scientific-practical foundations for the prescription of physical training in older women with obesity
Aging leads to an alteration in the immune response characterized by a chronic inflammatory state and a progressive decrease in muscle quantity and quality a situation that increases in women and in the presence of obesity With respect to muscle quality intramuscular infiltration of adipose tissue has been considered a relevant parameter involved in the relationship between aging-obesity-inflammation As a therapeutic strategy physical training with resistance exercises or also known as strength training has been shown to be effective in increasing skeletal muscle mass in this age group However its role on muscle quality in normal-weight versus obese older women has not been fully addressed
Hypothesis
A 12-week resistance exercise training program is effective in improving muscle quality immune response and physical performance in normal weight and obese older women In addition to the above the investigators hypothesize that women with obesity will present greater baseline alterations so the percentage of change will be higher compared to older women with normal weight after the training program
Goals
The primary aim of this study is evaluate the effects of a 12-week resistance exercise training on muscle quality infiltration of intramuscular adipose tissue immune response and physical performance in older women between 60 and 79 years of age with obesity compared to older women with normal weight of the same age range
Specific goals
To evaluate the effects of a 12-week resistance exercise training program in elderly women between 60 and 79 years of age with obesity in comparison to older people with normal weight of the same age range on parameters of
Muscle architecture muscle thickness pennation angle and fascicle length and muscle quality functionalities power and strength
Immune response through inflammatory cytokines Tumor necrosis factor a TNFa interleukin-1 IL-1 IL-6 IL-8 and induction of neutrophil extracellular traps NETosis
Physical performance SPPB Body composition BIA and quality of life SF-36
Methodology
The present clinical trial will consider 2 study groups of older women between 60 and 79 years old normal weight BMI185 to 249 kgm 2 and fat 259 and obese BMI 30 to 399 Kgm 2 and fat 32 Participants will perform 12 weeks of training with resistance exercises 3 times a week Before and after training intramuscular infiltration of adipose tissue echogenicity will be measured by ultrasound followed by aspects of muscle architecture muscle thickness penile angle and fascicle length and functional parameters of muscle quality maximum strength determined by 1 repetition maximum-1RM maximum voluntary isometric strength of knee extensors through a lower limb force and power transducer Finally fasting blood samples will be obtained immune response and physical performance body composition physical activity level and quality of life will be evaluated
Study parametersendpoints
The main study endpoint is the decrease in echointensity as a marker of muscle quality evaluated through ultrasonography in the quadriceps muscles of the lower limbs of participants subjected to 12 weeks of resistance training
Secondary endpoints include Muscle architecture parameter morphological aspects of muscle quality muscle thickness pennation angle and fascicle length Functional parameters of muscle quality maximum voluntary isometric strength of knee extensors and lower limb power Immune response in blood TNFa IL-1 IL-6 IL-8 and NETosis Physical performance SPPB evaluation of maximum strength 1RM and handgrip strength Body composition fat mass and total muscle mass and for each lower limb and anthropometry waist - hip thigh and calf circumference leg length and knee height And Level of physical activity IPAQ and Quality of Life SF-36
Other study parameters include Age body weight body height body mass index BMI lipid profile glucose insulin HOMA index blood pressure heart rate and perception of effort using the Borg scale
Expected results
The effect of resistance exercise training on muscle quality in normal-weight versus obese older women is still unclear The present research project aims to demonstrate the effectiveness of this training modality in improving muscle quality parameters as well as measures of immune response and physical performance in older women However the investigators believe that the impact will be greater in women with obesity as they present greater baseline alterations compared to older normal weight women The possible findings will define the scientific-practical foundations for the prescription of physical training in older women with obesity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None