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

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 Overview

• Status: Completed
• Conditions: Stroke; Weight Change, Body
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 570186
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Functional Independence Measure (FIM) was measured within 72 hours of discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Functional Independence Measure (FIM) Gain	Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points	Within 72 hours
Mean Functional Independence Measure (FIM) efficiency	Mean FIM efficiency, calculated as [FIM gain]/ [rehabilitation length of stay (days)]	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.	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.	Within 72 hours

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: SZE CHIN JONG, MD, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Body Mass Index; Stroke Rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Body Weight; Stroke; Body Weight Changes
• Other Study ID Numbers: NHG-DSRB 2018/01084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No