Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program

Sarcopenia Clinical Trial

— STRONG  

Official title:

Sarcopenia Prevention With a Targeted Exercise and Protein Supplementation Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417531
• Other study ID #: 2017-02045
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: Heike A. Bischoff-Ferrari, MD, DrPH
• Phone: +41 44 255 27 57
• Email: heike.bischoff[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Frailty
• Kwashiorkor
• Malnutrition
• Malnutrition; Protein
• Sarcopenia

Intervention

Dietary Supplement:
• Protein Supplement
Predosed protein powder; can be added to various dishes and drinks
• 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
• Control Exercise
Program includes five flexibility exercises that can be easily performed at home

Locations

Country	Name	City	State
Switzerland	University Geriatric Medicine Felix Platter, Basel	Basel
Switzerland	Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli	Zurich	ZH

Sponsors (9)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Myostatin	Blood Sample Assessment: Myostatin	Baseline, 6, and 12 months
Other	IGF-1	Blood Sample Assessment: Insulin-like growth factor-1	Baseline, 6, and 12 months
Other	CRP	Blood Sample Assessment: C-Reactive Protein	Baseline, 6, and 12 months
Other	Kidney function	Blood Sample Assessment: creatinine	Baseline, 6, and 12 months
Other	25-hydroxyvitamin D	Blood Sample Assessment: 25-hydroxyvitamin D	Baseline, 6, and 12 months
Other	Fasting insulin levels	Blood Sample Assessment: fasting insulin levels	Baseline, 6, and 12 months
Other	Fasting blood glucose	Blood Sample Assessment: fasting blood glucose	Baseline, 6, and 12 months
Other	Change muscle quality (sub-sample of 140 participants)	Assessed with whole Body MRI's in a subsample of f140 participants	Baseline and 12 months
Other	Any non-vertebral fracture	All fractures will be confirmed by x-ray or medical record.	every 2 months over 12 months
Other	Mortality	will be assessed by personal contact	every 2 months over 12 months
Other	Rate of SAEs in general	Serious Adverse Events	over 12 months
Other	Rate of SAEs related to study intervention	Serious Adverse Events	over 12 months
Other	Adherence to intervention (dietary supplement)	nitrogen excretion from 24-h/spot urine	Baseline, 6, and 12 months
Other	Adherence to intervention (dietary supplement)	will be assessed by questionnaire and diary	over 12 months
Other	Adherence to intervention (exercise)	will be assessed by questionnaire and diary	over 12 months
Other	Covariate: Hearing	will be assessed by a hearing test	over 12 months
Primary	Rate of falling	The circumstances and injuries associated with the fall will be ascertained with a questionnaire.	12 months
Secondary	Functional decline (change in lower extremity function)	will be assessed with the Short Physical Performance Battery (SPPB)	Baseline, 6, and 12 months
Secondary	Proportion of seniors with any falls and injurious falls	using the same method as for the primary endpoint	every 2 months over 12 months
Secondary	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
Secondary	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
Secondary	Proportion of seniors admitted to nursing homes (loss of autonomy)	participants will be asked at visits/phone calls	every 2 months over 12 months
Secondary	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
Secondary	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
Secondary	Change in grip strength	Measured with Martin Vigorimeter	Baseline, 6, and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in physical activity	will be assessed by an excerpt from the Nurses' Health Study (NHS) questionnaire	Baseline, 6, and 12 months
Secondary	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