Body Composition, Frailty, and Function in Rehabilitation

NCT06527742 | Recruiting

• 1 other identifier: CGOct23S04
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frailty; Stroke; Debility Due to Disease

Keywords

Stroke; Frailty; Sarcopenia; Deconditioning; Body fat; Skeletal muscle mass; Phase angle; Bioimpedance analysis; Body composition measurement

Outcome Measures

Primary Outcomes (1)

• M-FIM

  Motor component of the Functional Independence Measure

  Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later

Secondary Outcomes (2)

• M-FIM effectiveness

  Upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later

• Grip strength

  Baseline at recruitment, and upon discharge from the inpatient rehabilitation unit which is an average of 2 weeks later

Study Arms (1)

Eligible patients

Consecutive purposive sample of all patients with stroke, deconditioning, lung disease, or amputation admitted to the Changi General Hospital Rehabilitation Medicine unit All patients transferred in for inpatient rehabilitation will undergo case note screening and physical examination as part of their routine post-transfer clerking. Patients fulfilling the inclusion and exclusion criteria will be approached for recruitment and enrolment within 48 work hours of transfer in to the unit. Baseline measurements will be collected, and they will undergo usual rehabilitation with our multidisciplinary team. Repeat measurements will also be collected upon discharge.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Transferred under the Rehabilitation Medicine service for post-acute rehabilitation
• Rehabilitation diagnosis of:
• 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
• Lower limb amputees (transtibial or transfemoral)
• Medically stable
• Able to understand English consent form or suitably-translated document, or have a family member/legally-authorised representative who is able to do so and willing to provide consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

RECRUITING

MeSH Terms

Conditions

Frailty; Stroke; Sarcopenia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• Edmund JR Neo, MBBS

  Singapore Health Services Pte Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edmund JR Neo, MBBS

CONTACT

065 6936 6462; edmund.neo.jin.rui@singhealth.com.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 30, 2024
• Study Start: December 9, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)