Sarcopenia, Frailty, Malnutrition; Protein, Fall
Conditions
Keywords
Protein supplementation, Home exercise program, Falls prevention, Seniors, Autonomy
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 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.
Interventions
DIETARY_SUPPLEMENTProtein Supplement
Predosed protein powder; can be added to various dishes and drinks
DIETARY_SUPPLEMENTProtein-free Supplement
Predosed protein-free powder; can be added to various dishes and drinks
PROCEDUREActive Exercise
Program includes five strength exercises that can be easily performed at home
PROCEDUREControl Exercise
Program includes five flexibility exercises that can be easily performed at home
Sponsors
University of Zurich
Swiss National Science Foundation
University Hospital, Zürich
University Geriatric Medicine Felix Platter, Basel, Switzerland
Omanda AG, Baar, Switzerland
Ferrari Data Solution
City Hospital Waid and Triemli, Zurich, Switzerland
Cantonal Hospital of St. Gallen
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
2x2 factorial design
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of falling | 12 months | The circumstances and injuries associated with the fall will be ascertained with a questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional decline (change in lower extremity function) | Baseline, 6, and 12 months | will be assessed with the Short Physical Performance Battery (SPPB) |
| Proportion of seniors with any falls and injurious falls | every 2 months over 12 months | using the same method as for the primary endpoint |
| Proportion of seniors with established frailty | Baseline, 6, and 12 months | Frailty will be defined as 3 out of the following 5 criteria are met: 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 |
| Proportion of seniors with sarcopenia | Baseline, 6, and 12 months | will be assessed both with the Baumgartner definition (muscle mass alone) and the European Working Group definition by Cruz-Jentoft24 (composite definition of muscle mass and impaired grip strength or gait speed) |
| Proportion of seniors admitted to nursing homes (loss of autonomy) | every 2 months over 12 months | participants will be asked at visits/phone calls |
| Change in gait speed | Baseline, 6, and 12 months | Gait speed will be measured over a distance of 4 meters. The participants will be asked to walk in their usual pace |
| Change in reaction time | Baseline, 6, and 12 months | Reaction time will be assessed with repeated chair stands (5 repeats as part of the SPPB) |
| Change in grip strength | Baseline, 6, and 12 months | Measured with Martin Vigorimeter |
| Change in aerobic capacity | Baseline, 6, and 12 months | Aerobic capacity will be assessed with the 6 minute walk test. A walked distance of \< 300 m will be used as a frailty criteria |
| Change in muscle mass (arms and legs) | Baseline, 6, and 12 months | will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare) |
| Change in bone mineral density (hip and lumbar spine) | Baseline and 12 months | will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare) |
| Change in physical activity | Baseline, 6, and 12 months | will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire |
| Change in quality of life | Baseline, 6, and 12 months | will be assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale |
Countries
Switzerland
Contacts
PRINCIPAL_INVESTIGATORHeike A. Bischoff-Ferrari, MD, DrPH
University of Basel
Outcome results
None listed