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Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program (STRONG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417531
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : September 16, 2020
Sponsor:
Collaborators:
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 St. Gallen, Switzerland
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Frailty Malnutrition; Protein Fall Dietary Supplement: Protein Supplement Dietary Supplement: Protein-free Supplement Procedure: Active Exercise Procedure: Control Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: 2x2 factorial design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Protein Supplement plus Active Exercise
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)
Dietary Supplement: Protein Supplement
Predosed protein powder; can be added to various dishes and drinks
Other Name: Moltein® Ready-to-Shake

Procedure: Active Exercise
Program includes five strength exercises that can be easily performed at home

Active Comparator: Protein-free Supplement plus Active Exercise
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)
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

Active Comparator: Protein Supplement plus Control Exercise
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)
Dietary Supplement: Protein Supplement
Predosed protein powder; can be added to various dishes and drinks
Other Name: Moltein® Ready-to-Shake

Procedure: Control Exercise
Program includes five flexibility exercises that can be easily performed at home

Sham Comparator: Protein-free Supplement plus Control Exercise
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)
Dietary Supplement: Protein-free Supplement
Predosed protein-free powder; can be added to various dishes and drinks

Procedure: Control Exercise
Program includes five flexibility exercises that can be easily performed at home




Primary Outcome Measures :
  1. Rate of falling [ Time Frame: 12 months ]
    The circumstances and injuries associated with the fall will be ascertained with a questionnaire.


Secondary Outcome Measures :
  1. Functional decline (change in lower extremity function) [ Time Frame: Baseline, 6, and 12 months ]
    will be assessed with the Short Physical Performance Battery (SPPB)

  2. Proportion of seniors with any falls and injurious falls [ Time Frame: every 2 months over 12 months ]
    using the same method as for the primary endpoint

  3. Proportion of seniors with established frailty [ Time Frame: 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

  4. Proportion of seniors with sarcopenia [ Time Frame: 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)

  5. Proportion of seniors admitted to nursing homes (loss of autonomy) [ Time Frame: every 2 months over 12 months ]
    participants will be asked at visits/phone calls

  6. Change in gait speed [ Time Frame: 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

  7. Change in reaction time [ Time Frame: Baseline, 6, and 12 months ]
    Reaction time will be assessed with repeated chair stands (5 repeats as part of the SPPB)

  8. Change in grip strength [ Time Frame: Baseline, 6, and 12 months ]
    Measured with Martin Vigorimeter

  9. Change in aerobic capacity [ Time Frame: 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

  10. Change in muscle mass (arms and legs) [ Time Frame: Baseline, 6, and 12 months ]
    will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare)

  11. Change in bone mineral density (hip and lumbar spine) [ Time Frame: Baseline and 12 months ]
    will be measured with IDXA machines (intelligent dual x-ray absorptiometry by GE Healthcare)

  12. Change in physical activity [ Time Frame: Baseline, 6, and 12 months ]
    will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire

  13. Change in quality of life [ Time Frame: Baseline, 6, and 12 months ]
    will be assessed using the German Version of EuroQuol EQ5D-3L questionnaire according to the Austrian reference scale


Other Outcome Measures:
  1. Health care utilization [ Time Frame: every 2 months over 12 months ]
    assessed with a simple questionnaire to collect health care utilization information prospectively (MD visit, PT visit, hospitalizations in acute care etc)

  2. Myostatin [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: Myostatin

  3. IGF-1 [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: Insulin-like growth factor-1

  4. CRP [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: C-Reactive Protein

  5. Kidney function [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: creatinine

  6. 25-hydroxyvitamin D [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: 25-hydroxyvitamin D

  7. Fasting insulin levels [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: fasting insulin levels

  8. Fasting blood glucose [ Time Frame: Baseline, 6, and 12 months ]
    Blood Sample Assessment: fasting blood glucose

  9. Change muscle quality (sub-sample of 140 participants) [ Time Frame: Baseline and 12 months ]
    Assessed with whole Body MRI's in a subsample of f140 participants

  10. Any non-vertebral fracture [ Time Frame: every 2 months over 12 months ]
    All fractures will be confirmed by x-ray or medical record.

  11. Mortality [ Time Frame: every 2 months over 12 months ]
    will be assessed by personal contact

  12. Rate of SAEs in general [ Time Frame: over 12 months ]
    Serious Adverse Events

  13. Rate of SAEs related to study intervention [ Time Frame: over 12 months ]
    Serious Adverse Events

  14. Adherence to intervention (dietary supplement) [ Time Frame: Baseline, 6, and 12 months ]
    nitrogen excretion from 24-h/spot urine

  15. Adherence to intervention (dietary supplement) [ Time Frame: over 12 months ]
    will be assessed by questionnaire and diary

  16. Adherence to intervention (exercise) [ Time Frame: over 12 months ]
    will be assessed by questionnaire and diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417531


Contacts
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Contact: Heike A. Bischoff-Ferrari, MD, DrPH +41 44 255 27 57 heike.bischoff@usz.ch
Contact: Annemarie Fridrich, PhD +41 44 417 30 48 Annemarie.Fridrich@usz.ch

Locations
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Switzerland
Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli Recruiting
Zurich, ZH, Switzerland, 8037
Contact: Heike A Bischoff-Ferrari, MD, DrPH    +41 44 255 27 57    Heike.Bischoff@usz.ch   
Contact: Lena Mink    +41 44 417 20 14    Lena.Mink@usz.ch   
Principal Investigator: Heike A Bischoff-Ferrari, MD, DrPH         
University Geriatric Medicine Felix Platter, Basel Recruiting
Basel, Switzerland, 4012
Contact: Reto W Kressig, MD    +41 61 326 40 22    RetoW.Kressig@felixplatter.ch   
Contact: Stephanie Bridenbaugh, MD    +41 61 326 48 21    Stephanie.Bridenbaugh@felixplatter.ch   
Principal Investigator: Reto W Kressig, MD         
Sponsors and Collaborators
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 St. Gallen, Switzerland
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Heike A. Bischoff-Ferrari, MD, DrPH University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03417531    
Other Study ID Numbers: 2017-02045
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
Protein supplementation
Home exercise program
Falls prevention
Seniors
Autonomy
Additional relevant MeSH terms:
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Sarcopenia
Malnutrition
Kwashiorkor
Frailty
Nutrition Disorders
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Severe Acute Malnutrition