Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
1 other identifier
observational
54
1 country
1
Brief Summary
Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2021
CompletedFirst Submitted
Initial submission to the registry
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2022
CompletedNovember 2, 2022
November 1, 2022
10 months
April 26, 2021
November 1, 2022
Conditions
Keywords
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.
Interventions
very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)
Eligibility Criteria
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
- Universiti Putra Malaysialead
- National Cancer Institute, Malaysiacollaborator
Study Sites (1)
National Cancer Institute
Putrajaya, 62250, Malaysia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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