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Effects of Physical Exercise on Sarcopenia After Bariatric Surgery (EXPOBAR)

Primary Purpose

Sarcopenic Obesity, Bariatric Surgery Candidate

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
EXPOBAR
Sponsored by
University of Évora
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenic Obesity focused on measuring bariatric surgery, quality of life, metabolic risk factors,, fat-free mass, sarcopenia, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital
  • Aged between 18 years and 60 years
  • Contraindication to the practice of exercise
  • Agree to participate in the study

Exclusion Criteria:

  • Patients with problems in locomotion
  • Surgical complications
  • Psychiatric diseases and neurological disorders

Sites / Locations

  • Cláudia Amaro dos SantosRecruiting
  • Universidade de ÉvoraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

The duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities

Outcomes

Primary Outcome Measures

Body weight
Weight evaluation will be done using a scale
Height
Height evaluation will be done using a stadiometer
Abdominal circumference
Abdominal circumference will be determined by a measuring tape
HDL cholesterol in mg/dl
Blood sample
LDL cholesterol in mg/dl
Blood sample
Triglycerides in mg/dl
Blood sample
Glucose in mg/dl
Blood sample
Insulin in µIU/mL
Blood sample
Glycated hemoglobin in %
Blood sample
Alcohol intake
assessment of daily consumption through clinical data questionnaire
Mean blood pressure
Evaluation with Sphygnomanonetro
Concentration of ghrelin in pg/mg
blood ghrelin and leptin measurement
Concentration of leptin in pg/mg
blood ghrelin and leptin measurement
Lower limbs muscle strength
Lower limbs muscle strength will be evaluated with Biodex
Upper limbs muscle strength
The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)
Cardiorespiratory fitness
6-minute walk test (TC6)
Cardiorespiratory
Sit-to-stand test for 30 seconds

Secondary Outcome Measures

Life Quality
Questionary "BAROS" as a self-report measure, validated for the Portuguese population specific for bariatric surgery
Salivary amylase
Saliva harvest
physical activity level
Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity
Glycemia Variation in mg/dl
Evaluation continues through an implantable device for 5 days

Full Information

First Posted
February 15, 2022
Last Updated
March 12, 2022
Sponsor
University of Évora
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1. Study Identification

Unique Protocol Identification Number
NCT05289219
Brief Title
Effects of Physical Exercise on Sarcopenia After Bariatric Surgery
Acronym
EXPOBAR
Official Title
Effects of Physical Exercise on Sarcopenia After Bariatric Surgery: Protocol of a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Évora

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The study will include 60 patients awaiting bariatric surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity and sedentary behavior will be determined
Detailed Description
Bariatric surgery is the treatment of severe obesity with associated pathologies, with proven evidence in its benefits. Treating overweight allows a better and even reversal of pathologies associated with obesity. In this context, we know that physical exercise is important in the process of weight loss, however, and especially in bariatric surgery, the characteristics of physical activity are not consensual, as well as the effect of programs and physical exercise in this population. Weight loss associated with bariatric surgery is greatly associated with a significant reduction of skeletal muscle and bone mineral mass, which leads us to induce that after bariatric surgery, patients incur an increased risk of sarcopenia. The need for prophylactic programs that prevent sarcopenia in bariatric surgery patients seems to be one of the crucial points for the framing of long-term surgical success of bariatric and metabolic surgery. This randomized clinical trial will aim to study the effects of a 16-week supervised exercise intervention program on the prevention of sarcopenia after bariatric surgery This randomized controlled trial study will include 60 patients of both sexes on the waiting list for bariatric surgery and who have subsequently performed the surgery. They will be randomized into 2 groups, experimental and control. The intervention will take place 1 month after surgery, for a total of 16 weeks. Parameters of body composition, metabolic risk, quality of life, physical activity, and sedentary behavior will be determined. Assessments will take place in five moments, the surgery, the intervention, the post-intervention, six months after the intervention, twelve months after the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenic Obesity, Bariatric Surgery Candidate
Keywords
bariatric surgery, quality of life, metabolic risk factors,, fat-free mass, sarcopenia, exercise

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
Participant
Masking Description
Randomization is performed using a random selection method from the waiting list and the data will be coded and transferred to the database, depending on the intervention group and control group. Data analysis will be done statistically. Each participant will be randomly assigned to each group after signing the informed consent and conducting the initial assessments. All laboratory samples and data collected will be identified with identification ID, safeguarding the confidentiality of the collected data. At the end of this study, all participants of the control group will be offered the same intervention as the exercise group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The duration of the program is 16-weeks, 3-times a week, for up to 50 minutes per session, starting 1 month after surgery, based on the recommendations of the WHO and the ACSM, because the guidelines for morbidly obese patients undergoing bariatric surgery are not defined. Information on exercises for morbidly obese adults is limited, so the exercise programs will follow the guidelines for adults aged 18 to 65 years healthy, with chronic diseases or disabilities
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
EXPOBAR
Intervention Description
Each session will start with 5 minutes of warm-up and finalization with 10 minutes of a cool-down, with work of flexibility and proprioception. The maintenance of balance and postural stability may be compromised in obese individuals, depending on the degree of obesity, although the support base provided by the position of the foot is proportional to the structural morphology of each subject. Flexibility is also gradually impaired in obese individuals and of course, these changes may be related to postural changes aggravated by a sedentary lifestyle and biological aging itself alongside all metabolic alterations inherent to the pathology of obesity (Benetti et al., 2016). And the warm-up and the cool-down will be developed as the component of training with the evolution by phases, both in time and in intensity. The first phase will include 20 minutes of interval training, encompassing circuit strength training. Each phase will have an increment of 10 minutes in the central block.
Primary Outcome Measure Information:
Title
Body weight
Description
Weight evaluation will be done using a scale
Time Frame
1 year
Title
Height
Description
Height evaluation will be done using a stadiometer
Time Frame
1 year
Title
Abdominal circumference
Description
Abdominal circumference will be determined by a measuring tape
Time Frame
1 year
Title
HDL cholesterol in mg/dl
Description
Blood sample
Time Frame
1 year
Title
LDL cholesterol in mg/dl
Description
Blood sample
Time Frame
1 year
Title
Triglycerides in mg/dl
Description
Blood sample
Time Frame
1 year
Title
Glucose in mg/dl
Description
Blood sample
Time Frame
1 year
Title
Insulin in µIU/mL
Description
Blood sample
Time Frame
1 year
Title
Glycated hemoglobin in %
Description
Blood sample
Time Frame
1 year
Title
Alcohol intake
Description
assessment of daily consumption through clinical data questionnaire
Time Frame
1 year
Title
Mean blood pressure
Description
Evaluation with Sphygnomanonetro
Time Frame
1 year
Title
Concentration of ghrelin in pg/mg
Description
blood ghrelin and leptin measurement
Time Frame
1 year
Title
Concentration of leptin in pg/mg
Description
blood ghrelin and leptin measurement
Time Frame
1 year
Title
Lower limbs muscle strength
Description
Lower limbs muscle strength will be evaluated with Biodex
Time Frame
1 year
Title
Upper limbs muscle strength
Description
The muscle strength of the upper limbs will be evaluated by manual pressure dynamometry (Handgrip)
Time Frame
1 year
Title
Cardiorespiratory fitness
Description
6-minute walk test (TC6)
Time Frame
1 year
Title
Cardiorespiratory
Description
Sit-to-stand test for 30 seconds
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Life Quality
Description
Questionary "BAROS" as a self-report measure, validated for the Portuguese population specific for bariatric surgery
Time Frame
1 year
Title
Salivary amylase
Description
Saliva harvest
Time Frame
1 year
Title
physical activity level
Description
Accelerometers measure body movement, providing objective information about the frequency, intensity and duration of physical activity
Time Frame
1 year
Title
Glycemia Variation in mg/dl
Description
Evaluation continues through an implantable device for 5 days
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: As inclusion criteria, patients should be enrolled for bariatric surgery at the hospital Aged between 18 years and 60 years Contraindication to the practice of exercise Agree to participate in the study Exclusion Criteria: Patients with problems in locomotion Surgical complications Psychiatric diseases and neurological disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cláudia Amaro Dos Santos, PhD Student
Phone
968575053
Ext
+351
Email
cmendes@hevora.min-saude.pt
Facility Information:
Facility Name
Cláudia Amaro dos Santos
City
Évora
ZIP/Postal Code
7000-758
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cláudia Amaro D Santos
Phone
968575053
Ext
+351
Email
cmendes@hevora.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Armando Raimundo, Ph.D
First Name & Middle Initial & Last Name & Degree
Sandra Martins, Ph.D
First Name & Middle Initial & Last Name & Degree
Manuel Carvalho, Dr.
Facility Name
Universidade de Évora
City
Évora
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cláudia Amaro Dos Santos, PhD Student
Phone
968575053
Email
cmendes@hevora.min-saude.pt
First Name & Middle Initial & Last Name & Degree
CRI.COM Centre
First Name & Middle Initial & Last Name & Degree
HESE Hospital

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Effects of Physical Exercise on Sarcopenia After Bariatric Surgery

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