Body Composition, Frailty, and Function in Rehabilitation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorChangi General Hospital
About this trial
The investigators are investigating if body composition measures - in particular muscle mass, body fat, and something called the phase angle - are able to reliably predict functional outcomes for patients who are in an acute hospital for inpatient rehabilitation. The investigators also want to see if age and frailty affect these relationships.
Patients undergoing inpatient rehabilitation in our hospital will be monitored through a variety of frailty-specific tools, including strength and speed. The investigators will use a device called a body composition monitor (BCM) to record their body composition measurements. These will then be compared against their usual rehabilitation outcomes.
The investigators believe that there is a correlation between these measures and a patient's functional outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Transferred under the Rehabilitation Medicine service for post-acute rehabilitation
Stroke with motor weakness (modified Rankin scale 1-5), or
Deconditioning (from sepsis, post-ICU admission, heart failure, falls, musculoskeletal conditions with or without pain, or other conditions), or
Pulmonary rehabilitation (with or with long-term oxygen therapy), or
Disqualifiers
Pacemaker or implantable defibrillator in-situ
Medical devices or surgical implants that will interfere with BIA measurement per the manufacturer's guidelines
Abnormal fluid status (overloaded or depleted) at the point of screening
Cognitive or physical inability to tolerate sitting/lying still for 2mins (for BIA measurement)
Trial population
All patients over the age of 21 years admitted to the Changi General Hospital Rehabilitation Medicine unit in Singapore, up to a target sample size of 345 patients. There are no race-based subject restrictions. There will not be any gender-based or minority-based exclusion. Our patients come from other departments such as the Acute Stroke Unit and General Surgery, and have various medical backgrounds as well as medical conditions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
345 Participants
are grouped into 1 trial groupGroup A: Eligible patients
Trial outcomes
Primary outcomes
1
M-FIM
Motor component of the Functional Independence Measure
Time frame
Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks laterSecondary outcomes
1
M-FIM effectiveness
M-FIM effectiveness is a derivative of the M-FIM value which has been corrected for the ceiling effect that the M-FIM value sometimes encounters in patients with higher baseline FIM scores. This is a single outcome value with a single unit of measure.
Time frame
Upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later2
Grip strength
Handgrip strength measured in kg
Time frame
Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov