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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
| University Hospital, Zürich | OTHER |
| University Geriatric Medicine Felix Platter, Basel, Switzerland | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Supplement plus Active Exercise | Active Comparator | 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 program (3x30 minutes/week) |
|
| Protein-free Supplement plus Active Exercise | Active Comparator | Participants will ingest twice daily 23.7 g of a protein-free, isocaloric powder blend and perform a simple home exercise strength program (3x30 minutes/week) |
|
| Protein Supplement plus Control Exercise | Active Comparator | 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 program (3x30 minutes/week) |
|
| Protein-free Supplement plus Control Exercise | Sham Comparator | Participants will ingest twice daily 23.7 g of a protein-free, isocaloric powder blend and perform a joint flexibility home exercise program (3x30 minutes/week) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein Supplement | Dietary Supplement | Predosed protein powder; can be added to various dishes and drinks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of falling | The circumstances and injuries associated with the fall will be ascertained with a questionnaire. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional decline (change in lower extremity function) | will be assessed with the Short Physical Performance Battery (SPPB) | Baseline, 6, and 12 months |
| Proportion of seniors with any falls and injurious falls |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization | assessed with a simple questionnaire to collect health care utilization information prospectively (MD visit, PT visit, hospitalizations in acute care etc) | every 2 months over 12 months |
| Myostatin |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heike A. Bischoff-Ferrari, MD, DrPH | University of Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Geriatric Medicine Felix Platter, Basel | Basel | Basel | 4012 | Switzerland | ||
| Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D000073496 | Frailty |
| D007732 | Kwashiorkor |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D052580 | Muscle Stretching Exercises |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Omanda AG, Baar, Switzerland |
| UNKNOWN |
| Ferrari Data Solution | OTHER |
| City Hospital Waid and Triemli, Zurich, Switzerland | UNKNOWN |
| Cantonal Hospital of St. Gallen | OTHER |
| University Hospital, Basel, Switzerland | OTHER |
2x2 factorial design
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|
| Protein-free Supplement | Dietary Supplement | Predosed protein-free powder; can be added to various dishes and drinks |
|
| Active Exercise | Procedure | Program includes five strength exercises that can be easily performed at home |
|
| Control Exercise | Procedure | Program includes five flexibility exercises that can be easily performed at home |
|
using the same method as for the primary endpoint
| every 2 months over 12 months |
| Proportion of seniors with established frailty | 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 | Baseline, 6, and 12 months |
| Proportion of seniors with sarcopenia | 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) | Baseline, 6, and 12 months |
| Proportion of seniors admitted to nursing homes (loss of autonomy) | participants will be asked at visits/phone calls | every 2 months over 12 months |
| Change in gait speed | Gait speed will be measured over a distance of 4 meters. The participants will be asked to walk in their usual pace | Baseline, 6, and 12 months |
| Change in reaction time | Reaction time will be assessed with repeated chair stands (5 repeats as part of the SPPB) | Baseline, 6, and 12 months |
| Change in grip strength | Measured with Martin Vigorimeter | Baseline, 6, and 12 months |
| Change in aerobic capacity | Aerobic capacity will be assessed with the 6 minute walk test. A walked distance of < 300 m will be used as a frailty criteria | Baseline, 6, and 12 months |
| Change in muscle mass (arms and legs) | will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare) | Baseline, 6, and 12 months |
| Change in bone mineral density (hip and lumbar spine) | will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare) | Baseline and 12 months |
| Change in physical activity | will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire | Baseline, 6, and 12 months |
| Change in quality of life | will be assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale | Baseline, 6, and 12 months |
Blood Sample Assessment: Myostatin
| Baseline, 6, and 12 months |
| IGF-1 | Blood Sample Assessment: Insulin-like growth factor-1 | Baseline, 6, and 12 months |
| CRP | Blood Sample Assessment: C-Reactive Protein | Baseline, 6, and 12 months |
| Kidney function | Blood Sample Assessment: creatinine | Baseline, 6, and 12 months |
| 25-hydroxyvitamin D | Blood Sample Assessment: 25-hydroxyvitamin D | Baseline, 6, and 12 months |
| Fasting insulin levels | Blood Sample Assessment: fasting insulin levels | Baseline, 6, and 12 months |
| Fasting blood glucose | Blood Sample Assessment: fasting blood glucose | Baseline, 6, and 12 months |
| Change muscle quality (sub-sample of 140 participants) | Assessed with whole Body MRI's in a subsample of f140 participants | Baseline and 12 months |
| Any non-vertebral fracture | All fractures will be confirmed by x-ray or medical record. | every 2 months over 12 months |
| Mortality | will be assessed by personal contact | every 2 months over 12 months |
| Rate of SAEs in general | Serious Adverse Events | over 12 months |
| Rate of SAEs related to study intervention | Serious Adverse Events | over 12 months |
| Adherence to intervention (dietary supplement) | nitrogen excretion from 24-h/spot urine | Baseline, 6, and 12 months |
| Adherence to intervention (dietary supplement) | will be assessed by questionnaire and diary | over 12 months |
| Adherence to intervention (exercise) | will be assessed by questionnaire and diary | over 12 months |
| Covariate: Hearing | will be assessed by a hearing test | over 12 months |
| Zurich |
| Canton of Zurich |
| 8037 |
| Switzerland |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D010335 | Pathologic Processes |
| D000067011 | Severe Acute Malnutrition |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |