Weight Change, BodyNCT04625933
The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
An observational study of Weight Change, Body and Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes. Some data demonstrating that gains are often more rapid at BMI above "normal". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Change, Body, Stroke
- How many people
- 247 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jan 2019to 30 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient admitted to Tan Tock Seng Tertiary Rehabilitation Centre and fulfilled the inclusion criteria within the study period will be consented to the study.
Who may be able to join
- clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
- aged 18 years and above
- admitted directly from acute stroke units
- able to provide informed consent by self or by next of kin in incompetence patient
- must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes
Who cannot join
- rehabilitation was not the primary reason for the inpatient admission
- failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
- incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
- patients who were not of Asian ethnicity
Trial locations and contacts
1 site in 1 country.
About this study
Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes. Some data demonstrating that gains are often more rapid at BMI above "normal". The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.
- Conditions
- Weight Change, Body, Stroke
- Being tested
- No intervention
- Keywords
- Body Mass Index, Stroke Rehabilitation
- Medical subject headings
- Body Weight Changes, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure (FIM) on Admission
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM. The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
Measured: Functional Independence Measure (FIM) was measured within 72 hours of admission
Functional Independence Measure (FIM) on Discharge
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM. The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
Measured: Functional Independence Measure (FIM) was measured within 72 hours of discharge.
Secondary outcomes (4)
Mean Functional Independence Measure (FIM) Gain
Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points
Measured: Within 72 hours
Mean Functional Independence Measure (FIM) efficiency
Mean FIM efficiency, calculated as [FIM gain]/ [rehabilitation length of stay (days)]
Measured: Through study completion, an average of 1 year
Mean Functional Independence Measure (FIM) effectiveness
Mean FIM effectiveness was calculated as FIM gain/(126 points-FIM admission scores) with a value of 0-1.
Measured: Within 72 hours
Body Mass Index (BMI)
All patients had their weight (in kilograms) and height (in meters) measured on admission and discharge by rehabilitation nurses 72 hours after rehabilitation admission and prior to planned rehabilitation discharge. Weight was measured via sitting weighing scales or platform weighing scale for bedbound patients while height was measured with height measuring scale or measured in a supine position with legs outstretched and feet in dorsiflexion at end of bed for bedbound patients. BMI is then calculated as weight /height in meters squared.
Measured: Within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start31 Jan 2019
- Primary completion30 Jan 2020
- Study completion30 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight Change, BodyStudies 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
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Sze Chin, Tan Tock Seng Hospital
- Investigators
- SZE CHIN JONG, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625933
- Sponsor's protocol ID
- NHG-DSRB 2018/01084
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
- ClinicalTrials.gov ID
- NCT04625933
- Acronym / sponsor ID
- NHG-DSRB 2018/01084
- Conditions
- Weight Change, Body, Stroke
- Keywords
- Body Mass Index, Stroke Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 12 Nov 2020 (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.
Research has shown that rehabilitation at almost any Body Mass Index (BMI) level leads to positive functional outcomes. Some data demonstrating that gains are often more rapid at BMI above "normal". The aim of this study is to investigate the association between BMI and the functional progress of all patients admitted to Tan Tock Seng Tertiary Rehabilitation Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient admitted to Tan Tock Seng Tertiary Rehabilitation Centre and fulfilled the inclusion criteria within the study period will be consented to the study.
Key inclusion criteria (5 listed)
- clinical strokes (ischaemic or haemorrhagic) diagnosed by acute neurologists or neurosurgeons and confirmed on computerized tomography (CT) or Magnetic resonance imaging (MRI) brain imaging
- aged 18 years and above
- admitted directly from acute stroke units
- able to provide informed consent by self or by next of kin in incompetence patient
- must receive physical therapy (either physiotherapy, occupational therapy or speech therapy) at least 5 times a week with each session at least 30 minutes
Key exclusion criteria (4 listed)
- rehabilitation was not the primary reason for the inpatient admission
- failure to complete the rehabilitation program due to either an acute transfer off rehabilitation or a discharge against medical advice
- incomplete or missing Body Mass Index (BMI) or Functional Independence Measure (FIM) data
- patients who were not of Asian ethnicity
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 |
|---|---|---|
| No interventionNo intervention | Other | – |
Primary outcome
Functional Independence Measure (FIM) on Admission
Time frame: Functional Independence Measure (FIM) was measured within 72 hours of admission
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM. The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
Functional Independence Measure (FIM) on Discharge
Time frame: Functional Independence Measure (FIM) was measured within 72 hours of discharge.
Functional Independence Measure (FIM), the main primary outcome measure during rehabilitation was measured within 72 hours of admission and discharge by rehabilitation therapists all of whom were trained and certified in the use of the FIM. The FIM is an 18-item instrument comprising 13 motor items and 5 cognitive items, with each item graded on a 7-point ordinal scale (1 denotes complete dependence and 7 denotes complete independence), including the ability to perform activities of daily living (ADLs) across 6 areas (self-care, sphincter control, transfers, locomotion, communication, and social cognition). Total admission FIM (Ta-FIM) scores, total discharge FIM (Td-FIM) scores (18 - 126), motor FIM (m-FIM) sub-scores (13 - 91) and cognitive FIM (c-FIM) sub-scores (5 - 35), were tabulated.
4 secondary outcomes
Mean Functional Independence Measure (FIM) Gain
Time frame: Within 72 hours
Mean Functional Independence Measure (FIM) efficiency
Time frame: Through study completion, an average of 1 year
Mean Functional Independence Measure (FIM) effectiveness
Time frame: Within 72 hours
Body Mass Index (BMI)
Time frame: Within 72 hours
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 12 Nov 2020.
- Individual participant dataSharing planned: No
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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.
SZE CHIN JONG, MD principal investigator
Tan Tock Seng Hospital
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 Weight Change, Body and Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 4 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 12 Nov 2020. 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 Singapore. 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?
Functional Independence Measure (FIM) on Admission (time frame: Functional Independence Measure (FIM) was measured within 72 hours of admission). The study lists 2 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 12 Nov 2020.