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Completed

NCT Number: NCT04889378

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

Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.

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Key information

Conditions

Short Term Pre-habilitation Before Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute

Putrajaya, 62250, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Other

very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)

Primary outcomes

  1. anthropometry (waist circumference in cm)

    Time frame: baseline and after 2 weeks

    change in waist circumference at 2 weeks

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • National Cancer Institute, Malaysia

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 17, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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