Short Term Pre-habilitation Before Bariatric SurgeryNCT04889378
Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
An observational study of Short Term Pre-habilitation Before Bariatric Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Observational study is conducted in patient under short term pre-habilitation before bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Short Term Pre-habilitation Before Bariatric Surgery
- What is being tested?
- prehabilitation
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Apr 2021to 14 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: morbidly obese patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.
Read the 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.
- Being tested
- prehabilitation
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prehabilitationOther
very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
anthropometry (waist circumference in cm)
change in waist circumference at 2 weeks
Measured: baseline and after 2 weeks
body composition (weight in kg)
change in weight at 2 weeks. It will be measured by using BIA TANITA
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline and after 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start15 Apr 2021
- Primary completion1 Feb 2022
- Study completion14 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Term Pre-habilitation Before Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Responsible party
- Principal investigator, HO CHIOU YI, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889378
- Sponsor's protocol ID
- NMRR-21-355-58673
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Body Composition and Functional Status Following Short-term Pre-habilitation Among Morbidly Obese Patients Before Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04889378
- Acronym / sponsor ID
- NMRR-21-355-58673
- Keywords
- obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- National Cancer Institute, Malaysia
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study is conducted in patient under short term pre-habilitation before bariatric surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-habilitation | – | Other: prehabilitationparticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- morbidly obese patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prehabilitationvery low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day) | Other | Pre-habilitation |
Primary outcome
anthropometry (waist circumference in cm)
Time frame: baseline and after 2 weeks
change in waist circumference at 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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Short Term Pre-habilitation Before Bariatric Surgery, run by Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anthropometry (waist circumference in cm) (time frame: baseline and after 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.