Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program (NCT03417531) | Clinical Trial Compass
CompletedNot Applicable
Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program
Switzerland801 participantsStarted 2018-06-25
Plain-language 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 or possibly interactive benefit of exercise and Protein supplementation on fall prevention has yet to be confirmed in a large clinical trial. This study aims to test the individual and combined effect and cost-effectiveness of a simple home exercise program and / or protein supplementation on the risk of falling in seniors at high risk of progressive muscle mass loss and sarcopenia.
Who can participate
Age range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 fol…