Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program

NCT03417531 | Completed

• 1 other identifier: 2017-02045
• Study Type: interventional
• Target: 801
• Locations: 1 country
• Sites: 2

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.

Conditions

Sarcopenia; Frailty; Malnutrition; Protein; Fall

Keywords

Protein supplementation; Home exercise program; Falls prevention; Seniors; Autonomy

Outcome Measures

Primary Outcomes (1)

• Rate of falling

  The circumstances and injuries associated with the fall will be ascertained with a questionnaire.

  12 months

Secondary Outcomes (13)

• Functional decline (change in lower extremity function)

  Baseline, 6, and 12 months

• Proportion of seniors with any falls and injurious falls

  every 2 months over 12 months

• Proportion of seniors with established frailty

  Baseline, 6, and 12 months

• Proportion of seniors with sarcopenia

  Baseline, 6, and 12 months

• Proportion of seniors admitted to nursing homes (loss of autonomy)

  every 2 months over 12 months

Other Outcomes (17)

• Health care utilization

  every 2 months over 12 months

• Myostatin

  Baseline, 6, and 12 months

• IGF-1

  Baseline, 6, and 12 months

Study Arms (4)

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)

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)

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)

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)

Dietary Supplement: Protein-free Supplement; Procedure: Control Exercise

Interventions

Protein Supplement DIETARY_SUPPLEMENT

Predosed protein powder; can be added to various dishes and drinks

Also known as: Moltein® Ready-to-Shake

Protein Supplement plus Active Exercise; Protein Supplement plus Control Exercise

Protein-free Supplement DIETARY_SUPPLEMENT

Predosed protein-free powder; can be added to various dishes and drinks

Protein-free Supplement plus Active Exercise; Protein-free Supplement plus Control Exercise

Active Exercise PROCEDURE

Program includes five strength exercises that can be easily performed at home

Protein Supplement plus Active Exercise; Protein-free Supplement plus Active Exercise

Control Exercise PROCEDURE

Program includes five flexibility exercises that can be easily performed at home

Protein Supplement plus Control Exercise; Protein-free Supplement plus Control Exercise

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator
• University Hospital, Zürich: collaborator
• University Geriatric Medicine Felix Platter, Basel, Switzerland: collaborator
• Omanda AG, Baar, Switzerland: collaborator
• Ferrari Data Solution: collaborator
• City Hospital Waid and Triemli, Zurich, Switzerland: collaborator
• Cantonal Hospital of St. Gallen: collaborator
• University Hospital, Basel, Switzerland: collaborator

Study Sites (2)

University Geriatric Medicine Felix Platter, Basel

Basel, Basel, 4012, Switzerland

Location

Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli

Zurich, Canton of Zurich, 8037, Switzerland

Location

MeSH Terms

Conditions

Sarcopenia; Frailty; Kwashiorkor

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Severe Acute Malnutrition; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Heike A. Bischoff-Ferrari, MD, DrPH

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2x2 factorial design

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 31, 2018
• Study Start: June 25, 2018
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

CH (2)