STRONG Study: Prevention of Falls in Seniors at High Risk of Falling through Supplementation with Whey Protein and Strength Training
Zusammenfassung der Studie
Possible risk factors contributing to sarcopenia include physical inactivity and inadequate protein intake (= protein supply). It is suspected that in seniors with insufficient protein intake, supplementation with whey protein positively affects the maintenance of muscle mass. (Whey protein is a protein (= protein) derived from whey (whey is known as the watery by-product in cheese production). The whey protein used in this study has a particularly high proportion of L-leucine – an essential amino acid (= vital building block for protein that the human body cannot produce itself), which likely plays a central role in energy metabolism in muscle tissue.) The main objective of this study is to investigate the effect of whey protein as a supplement with and without a strength training program on the frequency of falls in older adults at high risk of falling. We are also interested in the effect on muscle strength, muscle mass, mobility, physical performance, and quality of life. The effect will be tested over 12 months in a total of 800 women and men who are at least 75 years old, have experienced a fall with injury in the last 12 months, and have reduced protein intake. Allocation to groups is done randomly. Neither the participants nor the investigator know which group the participants have been assigned to.
(BASEC)
Untersuchte Intervention
The study tests four groups. Two groups receive a whey protein powder (2x23.7 g per day), the other two groups receive a comparator powder without whey protein (2x23.7 g per day). Of the respective two groups, one group receives a home strength training program (3x30 min per week) and the other group a home mobility training program (3x30 min per week). This means the four groups are composed as follows:
Group 1: Whey protein powder + strength training
Group 2: Comparator powder without whey protein + strength training
Group 3: Whey protein powder + mobility training
Group 4: Comparator powder without whey protein + mobility training
(BASEC)
Untersuchte Krankheit(en)
Sarcopenia, the excessive loss of muscle mass and muscle strength with increasing age, significantly contributes to the risk of falling and loss of autonomy in seniors.
(BASEC)
- 75 years old or older - meets at least one of the following five criteria: 1) weight loss of more than 4.5 kg in the last 12 months, 2) muscle weakness measured by handgrip strength, 3) exhaustion, 4) slow walking speed, 5) low physical performance and/or has experienced a fall with injury in the last 12 months - Reduced protein intake - Lives independently at home or with assistance at home (BASEC)
Ausschlusskriterien
- Impairment of cognitive function - Cannot independently come to the study center - Cannot walk 3 meters without a walking aid - Severe renal dysfunction - Cannot follow the exercise program or take the powder - Diseases that impair walking function or increase the risk of falling (e.g., Parkinson's, hemiplegia) - Severe visual or hearing impairment - Insufficient German language skills to understand the instructions - Lives in a nursing or care home - Lives in the same household as another study participant (BASEC)
Studienstandort
Basel, Zürich
(BASEC)
Sponsor
Prof. Dr. med. Heike A. Bischoff-Ferrari
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Dr. med. Heike A. Bischoff-Ferrari
+41 44 255 27 57
heikea.bischoff-ferrari@clutteruzh.chUniversität Zürich
(BASEC)
Allgemeine Auskünfte
University of Zurich
(ICTRP)
Wissenschaftliche Auskünfte
University of Zurich
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.01.2018
(BASEC)
ICTRP Studien-ID
NCT03417531 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Sarcopenia PrevenTion with a TaRgeted Exercise and PrOtein SupplemeNtation ProGram (BASEC)
Wissenschaftlicher Titel
Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program (ICTRP)
Öffentlicher Titel
Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program (ICTRP)
Untersuchte Krankheit(en)
SarcopeniaFrailtyMalnutrition ProteinFall (ICTRP)
Untersuchte Intervention
Dietary Supplement: Protein SupplementDietary Supplement: Protein-free SupplementProcedure: Active ExerciseProcedure: Control Exercise (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Rate of falling (ICTRP)
Functional decline (change in lower extremity function);Proportion of seniors with any falls and injurious falls;Proportion of seniors with established frailty;Proportion of seniors with sarcopenia;Proportion of seniors admitted to nursing homes (loss of autonomy);Change in gait speed;Change in reaction time;Change in grip strength;Change in aerobic capacity;Change in muscle mass (arms and legs);Change in bone mineral density (hip and lumbar spine);Change in physical activity;Change in quality of life (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Swiss National Science Foundation;University Hospital, Z�rich;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 (ICTRP)
Weitere Kontakte
Heike A. Bischoff-Ferrari, MD, DrPH, University of Zurich (ICTRP)
Sekundäre IDs
2017-02045 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT03417531 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar