Status:
COMPLETED
Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Swiss National Science Foundation
University Hospital, Zürich
Conditions:
Sarcopenia
Frailty
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
Physical inactivity and protein malnutrition have been implicated to be key and modifiable causes of enhanced muscle mass loss among seniors. However, the individual benefit, as well as the additive o...
Detailed Description
The number of seniors age 75 and older is predicted to double by 2030, as is the number of seniors with mobility disability, physical frailty and resulting consequences, such as falls and loss of auto...
Eligibility Criteria
Inclusion
- At least 1 of 5 frailty criteria, definition by Linda Fried: 1) weight loss of \> 4.5 kg in the last 12 months; 2) reduced grip strength in Martin Vigorimeter test: ♂ ≤ 64 kPa, ♀ ≤ 42 kPa; 3) standardized question on exhaustion as published by Fried et al.; 4) gait speed \< 1 m/s; 5) 6-minute walk test \< 300 meters and/or Injurious (any injury) low trauma fall in the last 12 months prior to enrollment
- Reduced protein intake defined as a score ≤ 0.5 at item K of the Mini Nutritional Assessment (MNA)
- Community-dwelling or assisted living
Exclusion
- Mini-mental state examination (MMSE) \< 24 (inability to follow the study procedures and give written informed consent)
- Inability to come to the trial centers
- Inability to walk at least 3 meters with or without walking aid
- Severe kidney impairment (Glomerular filtration rate \[GFR\] \< 30 ml/min)
- Inability to follow exercise instruction or inability to take protein powder mixed in drink or food (test at baseline screening examination)
- Severe gait impairment or diseases with a risk of recurrent falling (due to conditions such as, e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
- 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 (necessary to follow instructions incl. STRONG exercise manual)
- Living in a nursing home
- Contraindication to treatment (e.g. allergy)
- Contraindication to the vitamin D standard of care therapy
Key Trial Info
Start Date :
June 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2025
Estimated Enrollment :
801 Patients enrolled
Trial Details
Trial ID
NCT03417531
Start Date
June 25 2018
End Date
March 24 2025
Last Update
May 1 2025
Active Locations (2)
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1
University Geriatric Medicine Felix Platter, Basel
Basel, Basel, Switzerland, 4012
2
Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli
Zurich, Canton of Zurich, Switzerland, 8037