]>
IRCT20241103063587N1 IRCT 2024-12-05 university of tehran Investigating the effect of regular physical activities on the bacteria of the intestines of obese people after gastric surgery Investigating the effect of regular physical activities on the abundance of some selected SCFA-producing bacteria in the intestines of obese people after gastric bariatric surgery 2024-12-10 anticipated 45 Complete https://irct.ir/trial/79986 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Basic scienece. N/A Obesity. The post-surgical rehabilitation protocol for patients undergoing surgery includes a structured exercise regimen designed to facilitate recovery. Initial Phase (Days 1-4) Walking: Patients start walking based on their tolerance levels. Aerobic Exercise (From Day 5 Onwards) Low to Moderate Intensity: Patients participate in low to moderate-intensity aerobic exercises, primarily walking or using a treadmill. Progression Phase (From Day 15 Onwards) Moderate Intensity Aerobic Exercise: Aerobic activities are intensified to moderate levels, guided by treadmill speed tests and steps per minute, ensuring that heart rates remain within 40% to 60% of the reserved heart rate. Strength Training: Moderate-intensity strength training exercises are introduced, focusing on the upper limbs during the first month. From the second to the third month, training will also include the lower limbs. Strength Training Details, Weights: Initially, light weights (1-2 kg) are used with a high number of repetitions. Every four weeks, weights are increased by 5%, while reducing repetitions. Walking Routine: In the initial four weeks post-surgery, patients gradually increase walking speed and duration, aiming for up to 150 minutes per week while maintaining a Rate of perceived exertion (RPE) between 12 and 14 where higher numbers indicate greater effort. Elastic Band Exercises: Frequency and Duration: Strength training with elastic bands is prescribed for three sessions per week, lasting 20 to 30 minutes each. Targeted Movements: Exercises include shoulder movements such as extension, flexion, abduction, and adduction; and hip movements like abduction, adduction, extension, and flexion. Patients receive an educational booklet that outlines exercise instructions. Progress is assessed through measurements taken one week before surgery and twelve weeks post-surgery.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information available.
public Mahdiyeh Zamankhanpour
North 4th floor, No 90, 17th Alley, North Kargar Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1439834434 +98 21 8863 5891 M.zamankhanpour@ut.ac.ir University of Tehran scientific Mahdiyeh Zamankhanpour
North 4th floor, No 90, 17th Alley, North Kargar Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1439834434 +98 21 8863 5891 M.zamankhanpour@ut.ac.ir University of Tehran Iran (Islamic Republic of) Absence of Unmanaged diabetes, poorly controlled hypertension, Major cardiovascular conditions, advanced pulmonary disease (COPD), Significant physical mobility restrictions, Serious neurological disorders that limit function Avoiding concurrent surgical procedures No previous weight loss surgery 20 years 50 years Both The progression of musculoskeletal conditions and debilitating neurological disorders that impair an individual's ability to perform functional assessments The start of any medications or supplements that can influence body weight, including Appetite suppressants, Weight-loss supplements (except those specifically prescribed by the post-surgery care team), Cardiovascular medications The presence of cardiac implantable electronic devices (CIEDs), such as pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac resynchronization therapy devices (CRT-Ds), which has been considered a contraindication for bioelectrical impedance analysis (BIA) due to concerns about potential electromagnetic interference A reluctance to maintain collaboration. E66.0 Obesity due to excess calories Lifestyle The post-surgical rehabilitation protocol for patients undergoing surgery includes a structured exercise regimen designed to facilitate recovery. Initial Phase (Days 1-4) Walking: Patients start walking based on their tolerance levels. Aerobic Exercise (From Day 5 Onwards) Low to Moderate Intensity: Patients participate in low to moderate-intensity aerobic exercises, primarily walking or using a treadmill. Progression Phase (From Day 15 Onwards) Moderate Intensity Aerobic Exercise: Aerobic activities are intensified to moderate levels, guided by treadmill speed tests and steps per minute, ensuring that heart rates remain within 40% to 60% of the reserved heart rate. Strength Training: Moderate-intensity strength training exercises are introduced, focusing on the upper limbs during the first month. From the second to the third month, training will also include the lower limbs. Strength Training Details, Weights: Initially, light weights (1-2 kg) are used with a high number of repetitions. Every four weeks, weights are increased by 5%, while reducing repetitions. Walking Routine: In the initial four weeks post-surgery, patients gradually increase walking speed and duration, aiming for up to 150 minutes per week while maintaining a Rate of perceived exertion (RPE) between 12 and 14 where higher numbers indicate greater effort. Elastic Band Exercises: Frequency and Duration: Strength training with elastic bands is prescribed for three sessions per week, lasting 20 to 30 minutes each. Targeted Movements: Exercises include shoulder movements such as extension, flexion, abduction, and adduction; and hip movements like abduction, adduction, extension, and flexion. Patients receive an educational booklet that outlines exercise instructions. Progress is assessed through measurements taken one week before surgery and twelve weeks post-surgery. The impact of bariatric surgery and regular physical activity on the prevalence of Coprococcus bacteria in the gut microbiome of obese patients. Timepoint: Alteration in the prevalence of Coprococcus species within the intestinal microbiome, comparing baseline measurements to those taken three months after intervention. Method of measurement: Utilizing a specialized kit designed for extracting Deoxyribonucleic acid from fecal samples, followed by analysis using the real-time polymerase chain reaction technique. The impact of bariatric surgery and regular physical activity on the prevalence of Roseburia bacteria in the gut microbiome of obese patients. Timepoint: Alteration in the prevalence of Roseburia species within the intestinal microbiome, comparing baseline measurements to those taken three months after intervention. Method of measurement: Utilizing a specialized kit designed for extracting Deoxyribonucleic acid from fecal samples, followed by analysis using the real-time polymerase chain reaction technique. The impact of bariatric surgery and regular physical activity on the prevalence of Ruminococcus bacteria in the gut microbiome of obese patients. Timepoint: Alteration in the prevalence of Ruminococcus species within the intestinal microbiome, comparing baseline measurements to those taken three months after intervention. Method of measurement: Utilizing a specialized kit designed for extracting Deoxyribonucleic acid from fecal samples, followed by analysis using the real-time polymerase chain reaction technique. The change in the abundance of the bacterial genus Alistipes in the gut microbiota of obese individuals after bariatric surgery and after regular physical activity. Timepoint: Alteration in the prevalence of Alistipes species within the intestinal microbiome, comparing baseline measurements to those taken three months after intervention. Method of measurement: Utilizing a specialized kit designed for extracting Deoxyribonucleic acid from fecal samples, followed by analysis using the real-time polymerase chain reaction technique. The change in the abundance of the bacterial genus Blautia in the gut microbiota of obese individuals after bariatric surgery and after regular physical activity. Timepoint: Alteration in the prevalence of Blautia species within the intestinal microbiome, comparing baseline measurements to those taken three months after intervention. Method of measurement: Utilizing a specialized kit designed for extracting Deoxyribonucleic acid from fecal samples, followed by analysis using the real-time polymerase chain reaction technique. The Effect of Regular Physical Activity on lipid profile changes in Obese Individuals after Bariatric Surgery. Timepoint: Changes in lipid profile before and 3 months after the intervention. Method of measurement: Utilizing Lipid control kits. The Effect of Regular Physical Activity on Glucose Profile Changes in Obese Individuals After Bariatric Surgery. Timepoint: Changes in glucose profile before and 3 months after the intervention. Method of measurement: Utilizing glucose kits. Impact of Regular Physical Activity on Fitness Test Outcomes in Post-Bariatric Surgery Patients with Obesity. Timepoint: Changes in physical fitness tests before and 3 months after the intervention. Method of measurement: Functional Capacity Assessment: Method: 12-Minute Walk Test (12MWT), Measurement: Distance covered in 12 minutes. Muscle Strength Evaluation: Method: One-Repetition Maximum (1RM) Tests, Focus: Lower limb muscles. Measurement: Number of repetitions completed. physical Activity Monitoring: Method: Personal Activity Logbook, Measurement: Self-reported activity levels and durations. Balance Assessment: Method: Standardized Balance Tests. The Impact of Regular Physical Activity on Body Composition Changes in Post-Bariatric Surgery Patients with Obesity. Timepoint: Changes in anthropometric factors (weight, body mass index, and body fat percentage) before and 3 months after the intervention. Method of measurement: Utilization of a bioimpedance analysis device, a height measuring device with an accuracy of 1 millimeter, and a scale with an accuracy of 0.01 kilograms. university of tehran Approved 2024-08-21 Ethics Committee in Research of the Faculty of Sports Sciences and Health at University of Tehran Northern 4th Floor, No 90, Nader Ebrahimi Alley(17) , North Karagar Tehran Tehran Iran (Islamic Republic of)