Clinical trial NCT02582138: Multicomponent Intervention for Physical Frailty and Sarcopenia
Official title: Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sarcopenia
Keywords: physical frailty
sarcopenia
exercise
nutrition
information and communications technology
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The SPRINTT study will evaluate the efficacy of a multicomponent intervention programme (physical activity, nutritional counselling/dietary intervention, and information and communications technology intervention) compared with a healthy aging lifestyle education programme on mobility disability, in non-disabled older people with physical frailty and sarcopenia.

Detailed description: As the life expectancy in European countries continues to increase, the maintenance of physical independence in older persons has become a major public health priority. The ability to ambulate without assistance is crucial for independent living and it is often the first ability to be lost in the process leading to disability. Older people who have impaired walking function need more assistance and are more likely to be placed in nursing homes, have a higher risk of morbidity, mortality and hospitalisation, and experience a reduced quality of life. The ultimate goals of the Sarcopenia and Physical fRailty IN older people: multicomponenT Treatment strategies (SPRINTT) project are to offer efficient treatment options, based on a multicomponent intervention including physical activity, nutrition and information and communications technology, to physically frail, sarcopenic older persons and to improve their quality of life. The result will directly contribute to the long-term sustainability and efficiency of health- and social-care systems. The conceptualisation of physical frailty and sarcopenia (PF\&S) as proposed in SPRINTT will promote significant advancements over the traditional approaches by enabling the precise operationalisation of the condition, a clear identification of the affected population and the rapid translation of findings to the clinical arena.

Eligibility criteria: Inclusion criteria:

1. Short Physical Performance Battery (SPPB) score between 3 (included) and 9 (included);
2. Able to complete the 400-m walk test within 15 min without sitting down, help from another person, use of a walker, or stopping for more than 1 minute at a time;
3. Presence of low muscle mass based on Dual Energy X-Ray Absorptiometry (DXA) scan, according to the Foundation for the National Institutes of Health Sarcopenia Project (FNIH) criteria:

   * Body mass index-adjusted appendicular lean mass (aLM; i.e., the sum of lean mass from both arms and legs): \<0.789 in men, and \<0.512 in women OR
   * aLM \<19.75 kg in men and \<15.02 kg in women
4. Willingness to be randomised to either intervention group and to follow the study protocol.

Exclusion criteria:

General

1. Unable or unwilling to provide informed consent or accept randomisation to either study group.
2. Plans to relocate out of the study area within the next 2 years or plans to be out of the study area for more than 6 consecutive weeks in the next year;
3. Residence in long-term care;
4. Household member enrolled in the study.

Clinical conditions:

1. Current diagnosis of schizophrenia, other psychotic or bipolar disorder;
2. Consumption of more than 14 alcoholic drinks per week;
3. Difficulty communicating with the study personnel due to speech, language, or (non-corrected) hearing problems;
4. Mini Mental State Examination lower than 24/30;
5. Severe osteoarthritis (e.g., awaiting joint replacement) that would interfere with the ability to participate fully in either study arm;
6. Cancer requiring treatment in the past 3 years, except for non-melanoma skin cancers or cancers that have an excellent prognosis (e.g., early stage breast or prostate cancer);
7. Lung disease requiring regular use of supplemental oxygen;
8. Inflammatory conditions requiring regular use of oral or parenteral corticosteroid agents;
9. Severe cardiovascular disease (including New York Heart Association class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator, or uncontrolled angina)
10. Upper and/or lower extremity amputation;
11. Peripheral arterial disease Lériche-Fontaine 3 or 4;
12. Parkinson's disease or other progressive neurological disorder;
13. Renal disease requiring dialysis;
14. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline 400-metre walk test;
15. Current participation in a structured exercise programme, physical therapy or cardiopulmonary rehabilitation;
16. Current enrolment in another randomised clinical trial involving lifestyle, nutrition, or pharmaceutical interventions;
17. Other medical, psychiatric, or behavioural factors that in the judgment of the principal investigator may interfere with the study participation or the ability to autonomously follow either the multicomponent or the healthy aging lifestyle education programmes;
18. Other illness of such severity that life expectancy is expected to be less than 12 months;
19. Clinical judgment concerning safety or non-compliance.

Temporary exclusion criteria

1. Uncontrolled hypertension (systolic blood pressure \>200 mm Hg, or diastolic blood pressure \>110 mm Hg);
2. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent hypoglycaemia;
3. Hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
4. Serious cardiac conduction disorder (e.g., third-degree heart block), uncontrolled arrhythmia, new Q waves within the past 6 months or ST-segment depression (\>3 mm) on the electrocardiogram;
5. Myocardial infarction, major heart surgery (i.e., valve replacement or coronary bypass graft), stroke, deep vein thrombosis, or pulmonary embolism in the past 6 months;
6. Use of growth hormone, oestrogens, progesterone, or testosterone supplementation in the past 3 months.

Primary outcomes:
measure: Incident of major mobility disability
timeFrame: 36 months
Secondary outcomes:
measure: Changes in lower extremity physical performance
timeFrame: 36 months
measure: Changes in upper extremity muscle strength
timeFrame: 36 months
measure: Changes in functional status (activities of daily living)
timeFrame: 36 months
measure: Changes in functional status (instrumental activities of daily living)
timeFrame: 36 months
measure: Changes in crude appendicular lean mass
timeFrame: 36 months
measure: Changes in body mass index-adjusted appendicular lean mass
timeFrame: 36 months
measure: Persistent mobility disability
timeFrame: 36 months
measure: Changes in body weight
timeFrame: 36 months
measure: Changes in body mass index
timeFrame: 36 months
measure: Changes in mid-arm circumference
timeFrame: 36 months
measure: Changes in waist circumference
timeFrame: 36 months
measure: Changes in hip circumference
timeFrame: 36 months
measure: Changes in calf circumference
timeFrame: 36 months
measure: Changes in nutritional status
timeFrame: 36 months
measure: Changes in cognitive function
timeFrame: 36 months
measure: Changes in mood
timeFrame: 36 months
measure: Incidence of self-reported falls
timeFrame: 36 months
measure: Incidence of injurious falls
timeFrame: 36 months
measure: Changes in quality of life
timeFrame: 36 months
measure: Changes in the use of healthcare services
timeFrame: 36 months
measure: All-cause mortality
timeFrame: 36 months
measure: Cost effectiveness
timeFrame: 36 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Francesco Landi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernabei R, Landi F, Calvani R, Cesari M, Del Signore S, Anker SD, Bejuit R, Bordes P, Cherubini A, Cruz-Jentoft AJ, Di Bari M, Friede T, Gorostiaga Ayestaran C, Goyeau H, Jonsson PV, Kashiwa M, Lattanzio F, Maggio M, Mariotti L, Miller RR, Rodriguez-Manas L, Roller-Wirnsberger R, Ryznarova I, Scholpp J, Schols AMWJ, Sieber CC, Sinclair AJ, Skalska A, Strandberg T, Tchalla A, Topinkova E, Tosato M, Vellas B, von Haehling S, Pahor M, Roubenoff R, Marzetti E; SPRINTT consortium. Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). BMJ. 2022 May 11;377:e068788. doi: 10.1136/bmj-2021-068788.