NCT04889378

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

April 26, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

obesity

Outcome Measures

Primary Outcomes (7)

  • anthropometry (waist circumference in cm)

    change in waist circumference at 2 weeks

    baseline and after 2 weeks

  • body composition (weight in kg)

    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)

    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)

    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)

    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)

    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)

    change in hand-grips strength at 2 weeks. Hand-grip strength will be measured by using Jammar Dynamometer

    baseline and after 2 weeks

Study Arms (1)

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

Interventions

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

Pre-habilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

morbidly obese patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute

Putrajaya, 62250, Malaysia

Location

MeSH Terms

Conditions

Obesity

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 26, 2021

First Posted

May 17, 2021

Study Start

April 15, 2021

Primary Completion

February 1, 2022

Study Completion

March 14, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Locations