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

NCT04625933 | Completed

• 1 other identifier: NHG-DSRB 2018/01084
• Study Type: observational
• Target: 247
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Change, Body; Stroke

Keywords

Body Mass Index; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mean Functional Independence Measure (FIM) Gain

  Within 72 hours

• Mean Functional Independence Measure (FIM) efficiency

  Through study completion, an average of 1 year

• Mean Functional Independence Measure (FIM) effectiveness

  Within 72 hours

• Body Mass Index (BMI)

  Within 72 hours

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 570186, Singapore

Location

MeSH Terms

Conditions

Body Weight Changes; Stroke

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• SZE CHIN JONG, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 12, 2020
• Study Start: January 31, 2019
• Primary Completion: January 30, 2020
• Study Completion: July 30, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)