Enhancing Muscle POWER in Geriatric Rehabilitatio
- Conditions
- Sarcopenia
- Registration Number
- NL-OMON26761
- Lead Sponsor
- Vrije Universiteit Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
1) Admitted to a geriatric rehabilitation centre for a hip fracture
2) Aged 65 years or older
3) Diagnosed with stage 1 or 2 sarcopenia (sarcopenia probable or confirmed) according to the revised European Working Group on Sarcopenia in Older People (EWGSOP2) definition
4) Written informed consent
1) Palliative care or other adverse prognosis precluding post-intervention follow-up
2) Specific medical history such as:
• Patients with ongoing cancer treatment or radiotherapy/ chemotherapy in the last 6 months.
• Any gastrointestinal disease that interferes with bowel function and nutritional intake (e.g. constipation or diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding)
• Other relevant medical history or medication that could prevent participation in the intervention or affect the study outcome as judged by the investigator (e.g. severe dementia, hypercalcaemia)
3) Patients in isolation/quarantaine
4) BMI >40 kg/m2 (morbid obesity)
5) Renal impairment (estimated Glomerular Filtration Rate <30 mL/min/1.73m2)
6) Dietary characteristics: known allergy to cow’s milk and milk products or the ingredients of the study products, known allergy to soy, known galactosaemia, known severe lactose intolerance, patients requiring a fibre-free diet
7) Current alcohol or drug abuse in opinion of the investigator
8) Unable to provide informed consent (e.g. severe dementia or deliriumpatient and legal representative)
9) Not understanding Dutch
10) Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
11) Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Feasibility (adherence to the RET and ONS intervention, drop-out rate and overall feasibility)<br>- Skeletal muscle mass (SMM)
- Secondary Outcome Measures
Name Time Method - Feasibility: participation rate<br>- Relative muscle mass: fat free mass percentage and relative SMM<br>- Muscle strength: handgrip strength and leg press 1-repetition maximum (1-RM)<br>- Physical performance: total Short Physical Performance Battery (SPPB) score and individual chair stand test and gait speed test<br>- Functional performance: Katz index for ADL and Lawton and Brody scale for IADL<br>- Mobility: Functional Ambulation Classification (FAC)<br>- Quality of life: EQ-5D-5L<br>- Malnutrition: Global Leadership Initiative on Malnutrition (GLIM) criteria <br>- Dietary intake: three-day dietary record <br>- Length of stay in geriatric rehabilitation, six-month institutionalization and hospitalization and six-month and two-year mortality