NCT03417531

Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 801 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Accepted

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.

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 autonomy. This causes an enormous challenge to the individual, to medical care, and the society as a whole. A condition that is considered central to the development of physical frailty and its consequences is sarcopenia, the loss of muscle mass and strength. To date sarcopenia is underdiagnosed in clinical care and effective treatments for sarcopenia are missing. 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. The STRONG trial will be a 2x2 factorial design multi-centre double-blind randomized controlled clinical trial among 800 senior men and women; study duration is 12 months. The primary endpoint is the rate of falling. Key secondary endpoints include functional decline, and the proportion of seniors with frailty, sarcopenia, and loss of autonomy. STRONG will further assess the cost-effectiveness of the interventions based on health care utilization data collected every 2 months from each participant and observed incidence of the endpoints. Mechanistic endpoints include change in muscle mass by DXA(arms and legs), change in myostatin levels, and muscle quality (based on MRI). The interventions are (1) a simple home exercise program (a validated strength-enhancing or a control joint flexibility exercise program) to be performed 3x30 minutes/week; and (2) protein supplementation (either 20g of whey protein or isocaloric powder given in two portions for breakfast and dinner each day). All participants will receive a control dose of 24'000 IU vitamin D per month (equivalent to 800 IU vitamin D/day) to ensure that over 97% of STRONG participants will be vitamin D replete (25-hydroxyvitamin D \> 20 ng/ml) during the course of the trial. The trial will have clinical visits at baseline, 6 months, and 12 months. In between clinical visits, telephone interviews will be performed every 2 months.

Conditions

• Sarcopenia
• Frailty
• Malnutrition; Protein
• Fall

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Protein Supplement	Predosed protein powder; can be added to various dishes and drinks
DIETARY_SUPPLEMENT	Protein-free Supplement	Predosed protein-free powder; can be added to various dishes and drinks
PROCEDURE	Active Exercise	Program includes five strength exercises that can be easily performed at home
PROCEDURE	Control Exercise	Program includes five flexibility exercises that can be easily performed at home

Timeline

• Start date: 2018-06-25
• Primary completion: 2025-03-24
• Completion: 2025-03-24
• First posted: 2018-01-31
• Last updated: 2026-01-20

Locations

2 sites across 1 country: Switzerland