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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625933
• Other study ID #: NHG-DSRB 2018/01084
• Status: Completed
• Start date: January 31, 2019
• Est. completion date: July 30, 2020

Study information

• Verified date: November 2020
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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". 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight Changes
• Stroke
• Weight Change, Body

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mean Functional Independence Measure (FIM) Gain	Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points	Within 72 hours
Secondary	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
Secondary	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
Secondary	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