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

Sponsor
Tan Tock Seng Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04625933
Collaborator
(none)
247
1
17.9
13.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational
Actual Enrollment :
247 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Body Mass Index (BMI) on Inpatient Stroke Rehabilitation Outcome: A Prospective Study From an East-Asian Cohort
Actual Study Start Date :
Jan 31, 2019
Actual Primary Completion Date :
Jan 30, 2020
Actual Study Completion Date :
Jul 30, 2020

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Secondary Outcome Measures

  1. Mean Functional Independence Measure (FIM) Gain [Within 72 hours]

    Mean FIM gain, calculated as [Td-FIM - Ta-FIM] points

  2. 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)]

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tan Tock Seng Hospital Singapore Singapore 570186

Sponsors and Collaborators

  • Tan Tock Seng Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jong Sze Chin, Registrar, Tan Tock Seng Hospital
ClinicalTrials.gov Identifier:
NCT04625933
Other Study ID Numbers:
  • NHG-DSRB 2018/01084
First Posted:
Nov 12, 2020
Last Update Posted:
Nov 12, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jong Sze Chin, Registrar, Tan Tock Seng Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 12, 2020