The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort

Completed

• Conditions: Stroke; Weight Change, Body

• Registration Number: NCT04625933
• Lead Sponsor: Tan Tock Seng Hospital

Brief 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". 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-31
• Primary Completion: 2020-01-30
• Study Completion: 2020-07-30
• Study First Submitted: 2020-10-30
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Study First Posted: 2020-11-12
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure (FIM) on Discharge	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.
Functional Independence Measure (FIM) on Admission	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.

Secondary Outcome Measures

Name	Time	Method
Mean Functional Independence Measure (FIM) efficiency	Through study completion, an average of 1 year	Mean FIM efficiency, calculated as \[FIM gain\]/ \[rehabilitation length of stay (days)\]
Mean Functional Independence Measure (FIM) effectiveness	Within 72 hours	Mean FIM effectiveness was calculated as FIM gain/(126 points-FIM admission scores) with a value of 0-1.
Mean Functional Independence Measure (FIM) Gain	Within 72 hours	Mean FIM gain, calculated as \[Td-FIM - Ta-FIM\] points
Body Mass Index (BMI)	Within 72 hours	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.

Trial Locations

Locations (1)

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore