Bariatric-metabolic Surgery - the Effect of Postoperative Exercising on Sarcopenia (SarxOb)

November 1, 2020 updated by: Masaryk University

Research of Sarcopenia in Patients After Bariatric-metabolic Surgery - the Effect of Programmed Aerobic and Power Exercising on the Functionality, Volume and Morphology of Muscle Tissue

The investigators' study published in 2020 (Pekar, M. et al.: The risk of sarcopenia 24 months after bariatric surgery - assessment by dual energy X-ray absorptiometry (DEXA): a prospective study; Videosurgery Miniinv 2020; https://doi.org/10.5114/wiitm.2020.93463) shows that patients are at risk of sar-copenia after bariatric-metabolic (BM) surgery. BM surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. The study shows that the lack of physical activity is typical for these patients. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone and muscle metabolism, patients are getting in risk of sarcopenia. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. This type of surgery leads to significant changes in body composition. Significant fat loss is followed by unwanted muscle loss. To the algorithm of postoperative care the investigators plan to include controlled exercise programs for these patients. The investigators do not know what the complexity and time required to keep patients in good condition and reduce the risk of sarcopenia is. The investigators want to find the adequate amount of physical activity while maintaining long-term compliance of these patients.

The study has been designed as a prospective randomized study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and will be approved by the Ethical Committee of the Hospital AGEL Ostrava-Vitkovice, Czech Republic.

Potential study participants will undergo an initial examination at the clinical department of the surgical department specializing in obesity. In addition to professional surgical and internal examination, the potential patient will be examined by a clinical psychologist for the ability to participate in this type of study for a long time. Informed consent will be provided to selected study participants.

50 patients who undergo surgery will be randomized in two cohorts:

  • Cohort 1: obese patients with LSG: 25 patients with controlled aerobic / anaerobic activity
  • Cohort 2: obese LSG patients 25 patients without controlled physical activity

The patients enrolled in the study are followed for the period of 24 months. Individual will be evaluated before the bariatric procedure and 3, 6, 12, 18 and 24 months after the procedure.

Primary goal of the study is to evaluate the Hypothesis 0 : there is no difference between muscle function, volume and morphology between patients after BM operations who are no longer controlled by physical activity and between patients who undergo controlled regular exercise programs under professional supervision.

Secondary objectives: Monitoring of knee cartilage during weight reduction after bariatric surgery and monitoring of gait biomechanics during weight reduction after bariatric surgery

Patients undergo the following examinations:

Weight: body weight will be measured on a calibrated scale. The measurement itself will be performed in underwear, without shoes.

Waist circumference: the circumference will be measured using a fixed tape measure.

Body composition: measurement of body composition of obese individuals will be performed using DXA (Dual-emission X-ray absorptiometry, Discovery A, Hologic).

Examination of muscle mass and muscle strength:

  • Muscle mass: measurement of the composition and structure of skeletal muscles and fat in the thigh will be performed using MRI (Magnetic Resonance Imaging)
  • Muscle strength: the measurement will be performed using a battery of tests:

handgrip dynamometer, chair-stand-walk test, test of getting up from a chair, test of 400 meters walk

Physical activity:

  • physical activity questionnaire
  • controlled regular exercise programs: patients will be divided into two cohorts - with and without physical intervention. Patients included in the intervention cohort with physical activity will undergo three months of strength endurance training under the supervision of a professional physiotherapist.

Quality of life: calibrated 36-Item Short Form Health Survey (SF-36) and The Impact of Weight on Quality of Life (IWQOL) questionnaire

Biochemical analyzes:

Blood samples will be taken from each test subject after 12 hours of fasting by venipuncture before the actual bariatric procedure and then repeatedly in the follow-up period after the procedure. The samples will be centrifuged under standard conditions and the concentrations of the following substances will then be determined in the serum samples:

• glucose, glycated hemoglobin, alkaline phosphatase, total calcium, phosphates, parathyroid hormone, total protein, albumin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, creatinine. After determination of these analytes, serum (plasma) aliquots will be frozen at -80 ° C until analysis of other selected parameters.

WITHDRAWAL FROM THE STUDY

Persons involved in the study may terminate their participation or be excluded from the study at any time for the following reasons:

  • Death of the subject
  • Voluntary withdrawal from the study: the subject voluntarily decides not to continue in the next part of the study.
  • Loss from follow-up: the subject does not show up for scheduled inspections more than one month after the scheduled inspection or examination.
  • Risk / benefit ratio: while evaluating the results during follow-up, the clinical coordinator finds that continuing the study is not in the best interests of the subject with respect to the subject.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index 30-50 kg/m2
  • ability to understand informed consent
  • signed informed consent
  • patient's residence within 100 km from Ostrava Czech Republic

Exclusion Criteria:

  • History of gastric surgery
  • acute gastric ulcers or inflammation
  • Type 1 Diabetes mellitus
  • celiac disease
  • history of malignity
  • previous bariatric-metabolic surgery or endoscopic obesity treatment,
  • specific genetic and humoral diseases connected to obesity (Prader-Willi syndrome, mutation of melanocortin receptor 4, etc.)
  • history of knee surgery
  • non MRI compatible patients' devices and implants
  • severe hematological diseases
  • acute or chronic pancreatitis
  • cirrhosis
  • severe psychiatric diseases
  • uncontrolled hypertense
  • immunological diseases
  • long-term corticoid therapy
  • uncontrolled thyroid diseases
  • renal insufficiency
  • alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: controlled group
25 patients after bariatric-metabolic surgery without controlled postprocedural training
Procedure: Laparoscopic sleeve gastrectomy
Sleeve gastrectomy involves removing a part of the stomach, limiting the amount of food the patient can eat.
Experimental: active group
25 patients after bariatric-metabolic surgery with controlled postprocedural training
Procedure: Laparoscopic sleeve gastrectomy
Sleeve gastrectomy involves removing a part of the stomach, limiting the amount of food the patient can eat.
Other: Strength endurance training
Patients included in the active cohort arm with physical activity will undergo three months of strength endurance training under the supervision of a professional physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of lean mass by DXA measures (in kg/m2)
Time Frame: 24 months
higher values mean better result
24 months
fat infiltration of muscles by MRI (in %)
Time Frame: 24 months
lower content of fat means better result
24 months
muscle strength by handgrip dynamometer (in kg)
Time Frame: 24 months
higher values in this physical performance test mean better result
24 months
muscle strength by walk test (in m)
Time Frame: 24 months
higher values in this physical performance test mean better result
24 months
muscle strength by Timed Up and Go test (in s)
Time Frame: 24 months
lower values in this physical performance test mean better result
24 months
thickness of cartilage surface of the knee by MRI (in mm)
Time Frame: 24 months
higher values mean better result
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of fat mass by DXA measures (in kg/m2)
Time Frame: 24 months
lower values mean better result
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Collaborators

University of Ostrava
Hospital AGEL Ostrava-Vitkovice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

November 1, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 1, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SarxOb_2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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