SarcopeniaSTRONGNCT03417531
Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program
A study testing Protein Supplement, Protein-free Supplement and Active Exercise in people with Sarcopenia and Frailty, run by University of Zurich at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Malnutrition; Protein
- What is being tested?
- Protein Supplement, Protein-free Supplement and Active Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 801 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 25 Jun 2018to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Geriatric Medicine Felix Platter, Basel
Basel, Basel, 4012
Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli
Zurich, Canton of Zurich, 8037
About this study
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.
Read the 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
- Being tested
- Protein Supplement, Protein-free Supplement, Active Exercise, Control Exercise
- Keywords
- Protein supplementation, Home exercise program, Falls prevention, Seniors, Autonomy
- Medical subject headings
- Sarcopenia, Frailty, Kwashiorkor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein SupplementDietary supplement
Also called Moltein® Ready-to-Shake
Predosed protein powder; can be added to various dishes and drinks
Protein-free SupplementDietary supplement
Predosed protein-free powder; can be added to various dishes and drinks
Active ExerciseProcedure or surgery
Program includes five strength exercises that can be easily performed at home
Control ExerciseProcedure or surgery
Program includes five flexibility exercises that can be easily performed at home
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Protein Supplement; Procedure: Active Exercise |
| 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) Receives: Dietary Supplement: Protein-free Supplement; Procedure: Active Exercise |
| 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) Receives: Dietary Supplement: Protein Supplement; Procedure: Control Exercise |
| 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) Receives: Dietary Supplement: Protein-free Supplement; Procedure: Control Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of falling
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
Measured: 12 months
Secondary outcomes (13)
Functional decline (change in lower extremity function)
will be assessed with the Short Physical Performance Battery (SPPB)
Measured: Baseline, 6, and 12 months
Proportion of seniors with any falls and injurious falls
using the same method as for the primary endpoint
Measured: 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
Measured: 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)
Measured: Baseline, 6, and 12 months
Proportion of seniors admitted to nursing homes (loss of autonomy)
participants will be asked at visits/phone calls
Measured: 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
Measured: 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)
Measured: Baseline, 6, and 12 months
Change in grip strength
Measured with Martin Vigorimeter
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline and 12 months
Change in physical activity
will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire
Measured: 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
Measured: Baseline, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start25 Jun 2018
- Primary completion24 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 801 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- 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 of St. Gallen, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Heike A. Bischoff-Ferrari, MD, DrPH, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417531
- Sponsor's protocol ID
- 2017-02045
- Other IDs
- 2017
- Acronym
- STRONG
- Status last verified
- Jan 2026
- First submitted
- 9 Jan 2018
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program
- ClinicalTrials.gov ID
- NCT03417531
- Acronym / sponsor ID
- STRONG / 2017-02045
- Conditions
- Sarcopenia, Frailty, Malnutrition; Protein, Fall
- Keywords
- Protein supplementation, Home exercise program, Falls prevention, Seniors, Autonomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 801 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- 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 of St. Gallen, University Hospital, Basel, Switzerland
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 24 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Protein Supplement plus Active Exercise | Active comparator | Dietary Supplement: Protein Supplement, Procedure: Active ExerciseParticipants 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 | Dietary Supplement: Protein-free Supplement, Procedure: Active ExerciseParticipants 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 | Dietary Supplement: Protein Supplement, Procedure: Control ExerciseParticipants 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 | Dietary Supplement: Protein-free Supplement, Procedure: Control ExerciseParticipants 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) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protein SupplementAlso: Moltein® Ready-to-ShakePredosed protein powder; can be added to various dishes and drinks | Dietary supplement | Protein Supplement plus Active Exercise, Protein Supplement plus Control Exercise |
| Protein-free SupplementPredosed protein-free powder; can be added to various dishes and drinks | Dietary supplement | Protein-free Supplement plus Active Exercise, Protein-free Supplement plus Control Exercise |
| Active ExerciseProgram includes five strength exercises that can be easily performed at home | Procedure or surgery | Protein Supplement plus Active Exercise, Protein-free Supplement plus Active Exercise |
| Control ExerciseProgram includes five flexibility exercises that can be easily performed at home | Procedure or surgery | Protein Supplement plus Control Exercise, Protein-free Supplement plus Control Exercise |
Primary outcome
Rate of falling
Time frame: 12 months
The circumstances and injuries associated with the fall will be ascertained with a questionnaire.
13 secondary outcomes
Functional decline (change in lower extremity function)
Time frame: Baseline, 6, and 12 months
Proportion of seniors with any falls and injurious falls
Time frame: every 2 months over 12 months
Proportion of seniors with established frailty
Time frame: Baseline, 6, and 12 months
Proportion of seniors with sarcopenia
Time frame: Baseline, 6, and 12 months
Proportion of seniors admitted to nursing homes (loss of autonomy)
Time frame: every 2 months over 12 months
Change in gait speed
Time frame: Baseline, 6, and 12 months
Change in reaction time
Time frame: Baseline, 6, and 12 months
Change in grip strength
Time frame: Baseline, 6, and 12 months
Change in aerobic capacity
Time frame: Baseline, 6, and 12 months
Change in muscle mass (arms and legs)
Time frame: Baseline, 6, and 12 months
Change in bone mineral density (hip and lumbar spine)
Time frame: Baseline and 12 months
Change in physical activity
Time frame: Baseline, 6, and 12 months
Change in quality of life
Time frame: Baseline, 6, and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Related trials for Sarcopenia
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heike A. Bischoff-Ferrari, MD, DrPH principal investigator
University of Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protein Supplement, Protein-free Supplement and Active Exercise in people with Sarcopenia and Frailty, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of falling (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.