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Completed

NCT Number: NCT04625933

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore, 570186

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Functional Independence Measure (FIM) on Admission

    Time frame: 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

    Time frame: 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 outcomes

  1. Mean Functional Independence Measure (FIM) Gain

    Time frame: Within 72 hours

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

  2. Mean Functional Independence Measure (FIM) efficiency

    Time frame: 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

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 12, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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