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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

Protocol summary

Study aim
Examining the impact of regular physical activity on the prevalence of specific short-chain fatty acid (SCFA)-producing gut microbes, alongside changes in physiological markers, body composition, and fitness levels in individuals with obesity who have undergone sleeve gastrectomy bariatric surgery.
Design
A clinical trial with an exercise group, non-blinded, randomized, conducted on 45 patients.
Settings and conduct
The study protocol involves the assessment of participants one week before and twelve weeks after surgery. The evaluation includes: Anthropometric, measurements, Quality of life questionnaires, Stool and blood sample collection, Functional tests, Physical activity and diet This study is conducted at Hakim Medical Center
Participants/Inclusion and exclusion criteria
Inclusion criteria Candidates between 20 and 50 years old diagnosed with severe obesity, Scheduled for sleeve gastrectomy procedure, without unmanaged long term health conditions, no previous bariatric surgery exclusion criteria The onset of musculoskeletal issues, debilitating neurological conditions, Implantation of electronic medical devices, Use of medications impacting body weight, Reluctance to cooperate
Intervention groups
Individuals with a body mass index (BMI) exceeding 35, the age of 20 to 50 years old
Main outcome variables
Bariatric surgery significantly alters the gut microbiota composition and metabolic profile in obese individuals, with notable changes in SCFA production. Regular physical activity after surgery can further enhance these beneficial changes, leading to improvements in physiological indicators, physical fitness, and body composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241103063587N1
Registration date: 2024-12-05, 1403/09/15
Registration timing: prospective

Last update: 2024-12-05, 1403/09/15
Update count: 0
Registration date
2024-12-05, 1403/09/15
Registrant information
Name
Mahdiyeh Zamankhanpour
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 5891
Email address
m.zamankhanpour@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-10, 1403/09/20
Expected recruitment end date
2025-01-19, 1403/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the effect of regular physical activities on the bacteria of the intestines of obese people after gastric surgery
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
More than 1 sample in each individual
Number of samples in each individual: 2
Stool samples will be collected from participants at two time points: Pre-operative baseline: Samples obtained before the surgical procedure. Post-operative follow-up: Samples collected three months after the surgery.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research of the Faculty of Sports Sciences and Health at University of Tehran
Street address
Northern 4th Floor, No 90, Nader Ebrahimi Alley(17) , North Karagar
City
Tehran
Province
Tehran
Postal code
1439834434
Approval date
2024-08-21, 1403/05/31
Ethics committee reference number
ETHIC-202408-1272

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

5

Description
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

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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.

4

Description
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

Intervention groups

1

Description
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.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
مرکز پزشکی حکیم
Full name of responsible person
Alireza Khalaj
Street address
No. 49, Hakim Building, Manzarnajad Street (formerly Niyam), Shariati Street, above Mirdamad
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 912 454 5451
Email
zarei814@yahoo.com
Web page address
http://www.hakimbest.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
university of tehran
Full name of responsible person
Alireza Haghighi
Street address
4th northern floor, No 90, Nader Ebrahimi (17) alley, North kargar Street
City
Tehran
Province
Tehran
Postal code
1439834434
Phone
+98 21 8863 5891
Email
mahdiyeh.zmnpur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of tehran
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mahdiyeh Zamankhanpour
Position
Post graduate student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
North 4th floor, No 90, 17th Alley, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439834434
Phone
+98 21 8863 5891
Fax
Email
M.zamankhanpour@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mahdiyeh Zamankhanpour
Position
Post graduate student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
North 4th floor, No 90, 17th Alley, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439834434
Phone
+98 21 8863 5891
Fax
Email
M.zamankhanpour@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Mahdiyeh Zamankhanpour
Position
Post graduate student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
North 4th floor, No 90, 17th Alley, North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1439834434
Phone
+98 21 8863 5891
Fax
Email
M.zamankhanpour@ut.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
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