Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery

November 1, 2022 updated by: HO CHIOU YI, Universiti Putra Malaysia
Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Observational study is conducted in patient under short term pre-habilitation before bariatric surgery. Data on anthropometry (waist circumference), body compositions (weight, muscle mass, fat free mass, fat mass, fat percentage and basal metabolic rate (BMR)), and functional status (handgrips strength) are collected.

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

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

Study Locations

  • Malaysia
      • Putrajaya, Malaysia, 62250
        • National Cancer Institute

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

morbidly obese patients

Description

Inclusion Criteria:

  • Obese or severe obese patients
  • Candidates for short term pre-habilitation among morbid obese patients before bariatric surgery
  • Aged more than 18 years old
  • Malaysian
  • Provided and signed informed consent

Exclusion Criteria:

  • Not a candidate for short term pre-habilitation among morbid obese patients before bariatric surgery
  • Aged <18 years old
  • Non-Malaysian
  • Not able to provide informed consent
  • chronic renal failure

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-habilitation
participants will join prehabilitation with very low calories diet (800-1000kcal/day) and moderate intensive aerobic exercise (1 hour per section; 3 sections per day) for 2 weeks before bariatric surgery.
Other: prehabilitation
very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anthropometry (waist circumference in cm)
Time Frame: baseline and after 2 weeks
change in waist circumference at 2 weeks
baseline and after 2 weeks
body composition (weight in kg)
Time Frame: baseline and after 2 weeks
change in weight at 2 weeks. It will be measured by using BIA TANITA
baseline and after 2 weeks
body composition (muscle mass in kg)
Time Frame: baseline and after 2 weeks
change in muscle mass at 2 weeks. It will be measured by using BIA TANITA
baseline and after 2 weeks
body composition (fat free mass in kg)
Time Frame: baseline and after 2 weeks
change in fat free mass at 2 weeks. It will be measured by using BIA TANITA
baseline and after 2 weeks
body composition (fat mass in kg)
Time Frame: baseline and after 2 weeks
change in fat mass at 2 weeks. It will be measured by using BIA TANITA
baseline and after 2 weeks
body composition (fat percentage in percentage)
Time Frame: baseline and after 2 weeks
change in fat percentage at 2 weeks. It will be measured by using BIA TANITA
baseline and after 2 weeks
functional status (hand-grips strength in kg)
Time Frame: baseline and after 2 weeks
change in hand-grips strength at 2 weeks. Hand-grip strength will be measured by using Jammar Dynamometer
baseline and after 2 weeks

Collaborators and Investigators

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

Sponsor

Universiti Putra Malaysia

Collaborators

National Cancer Institute, Malaysia

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 (ACTUAL)

April 15, 2021

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

March 14, 2022

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (ACTUAL)

May 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NMRR-21-355-58673

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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