NCT03417531.
| Trial name or title | Sarcopenia prevention with a targeted exercise and protein supplementation program |
| Methods | RCT, 2x2 factorial design, triple‐blinded |
| Participants | Target sample size: 800 participants Inclusion: age 80+; at least 1 of 5 Cardiovascular Health Study frailty criteria ( i) weight loss of > 4.5 kg in the last 12 months; ii) reduced grip strength in Martin Vigorimeter test: men ≤ 64 kPa, women ≤ 42 kPa; iii) standardised question on exhaustion as published by Fried et al. (Fried 2001); iv) gait speed < 1 m/s; v) 6‐minute walk test < 300 metres; Injurious (any injury) low trauma fall in the last 12 months prior to enrolment; At risk of malnutrition or established malnutrition based on the Mini Nutritional Assessment (MNA) screening tool (score ≤ 11); Community‐dwelling or assisted living Exclusion: MMSE < 24; inability to come to the trial centres; inability to walk at least 3 meters with or without walking aid; severe kidney impairment; inability to follow exercise instruction or inability to take protein powder mixed in drink or food; severe gait impairment or diseases with a risk of recurrent falling; major visual or hearing impairment or other serious illness that would preclude participation (e.g. alcohol abuse, alcoholic disease); inability to read/speak/write in German; living in a nursing home; contraindication to treatment (e.g. allergy); contraindication to the vitamin D standard of care therapy |
| Interventions | 1. Protein supplement plus active exercise: Participants will ingest twice daily 23.7 g of L‐leucine‐enriched whey protein isolate powder (equivalent to 20 g of protein) and perform a simple home exercise strength programme (3 x 30 minutes a week) 2. Active comparator: Protein‐free supplement plus active exercise: Participants will ingest twice daily 23.7 g of a protein‐free, isocaloric powder blend and perform a simple home exercise strength programme (3 x 30 minutes a week) 3. Active comparator: Protein supplement plus control exercise: Participants will ingest twice daily 23.7 g of L‐leucine‐enriched whey protein isolate powder (equivalent to 20 g of protein) and perform a joint flexibility home exercise programme (3 x 30 minutes a week) 4. Sham comparator: Protein‐free supplement plus control exercise: Participants will ingest twice daily 23.7 g of a protein‐free, isocaloric powder blend and perform a joint flexibility home exercise programme (3 x 30 minutes a week) |
| Outcomes | 1. Rate of falling 2. Mobility 3. Fallers, number of people with injurious falls 4. Frailty 5. Sarcopenia 6. Institutionalisation 7. Health care utilisation |
| Starting date | May 2018 |
| Contact information | Heike A. Bischoff‐Ferrari University of Zurich, SWITZERLAND Ph: +41 44 255 27 57 Email: heike.bischoff@usz.ch |
| Notes |