No registrations found.
ID
Source
Brief title
Health condition
Sarcopenia
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Feasibility (adherence to the RET and ONS intervention, drop-out rate and overall feasibility)
- Skeletal muscle mass (SMM)
Secondary outcome
- Feasibility: participation rate
- Relative muscle mass: fat free mass percentage and relative SMM
- Muscle strength: handgrip strength and leg press 1-repetition maximum (1-RM)
- Physical performance: total Short Physical Performance Battery (SPPB) score and individual chair stand test and gait speed test
- Functional performance: Katz index for ADL and Lawton and Brody scale for IADL
- Mobility: Functional Ambulation Classification (FAC)
- Quality of life: EQ-5D-5L
- Malnutrition: Global Leadership Initiative on Malnutrition (GLIM) criteria
- Dietary intake: three-day dietary record
- Length of stay in geriatric rehabilitation, six-month institutionalization and hospitalization and six-month and two-year mortality
Background summary
Sarcopenia and (risk of) malnutrition are estimated to be present in 56% and 47% of geriatric rehabilitation patients respectively. Resistance exercise training (RET) combined with protein supplementation has been recommended to increase muscle mass and strength in older adults. However, feasibility and efficacy in a geriatric rehabilitation setting remains to be established.
Study objective
The EMPOWER-GR RCT will test the hypothesis that a combined intervention of RET and protein supplementation with an oral nutritional supplement (ONS) is feasible in sarcopenic geriatric rehabilitation inpatients admitted after a hip fracture and increases muscle mass during the stay in geriatric rehabilitation and after discharge.
Study design
V0 (screening at admission to geriatric rehabilitation), V1 (week 0, randomisation, baseline), V2 (discharge from geriatric rehabilitation), V3 (week 13, end of intervention)
Intervention
The intervention group will receive a combination of three RET sessions per week with a leucine and vitamin D enriched whey protein-based oral nutritional supplement (ONS) twice daily on top of usual care for a total duration of 13 weeks. The control group will receive usual care.
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9444 |
| Other | METC VUmc : 2020.0621 |