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…
ID
Bron
Verkorte titel
Aandoening
Sarcopenia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
- Feasibility (adherence to the RET and ONS intervention, drop-out rate and overall feasibility)
- Skeletal muscle mass (SMM)
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
V0 (screening at admission to geriatric rehabilitation), V1 (week 0, randomisation, baseline), V2 (discharge from geriatric rehabilitation), V3 (week 13, end of intervention)
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL9444 |
Ander register | METC VUmc : 2020.0621 |