Multicomponent Intervention for Physical Frailty and Sarcopenia

Sarcopenia Clinical Trial

— SPRINTT  

Official title:

Sarcopenia and Physical fRailty IN Older People: Multi-componenT Treatment Strategies (SPRINTT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02582138
• Other study ID #: 115621
• Secondary ID: IMI-JU-09-2013-0
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2015
• Last updated: February 1, 2017
• Start date: January 2016
• Est. completion date: December 2018

Study information

• Verified date: February 2017
• Source: Catholic University of the Sacred Heart
• Contact: Emanuele Marzetti, MD, PhD
• Phone: +39 06 3015
• Email: emarzetti[@]live.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Multicomponent intervention (MCI)
The multicomponent intervention will include physical activity (PA), nutrition and information and communications technology (ICT). The PA will be of moderate intensity and will include aerobic, strength, flexibility, and balance training. Walking will be the primary mode of PA . The nutritional intervention will combine individual nutritional assessment and personalised dietary recommendations to achieve: a daily total energy intake of 25-30 kcal/kg body weight; an average protein daily intake between 1.0 and 1.2 g/Kg/body weight. The ICT component will involve the use of an ad hoc technological device to record actimetry data to support the elaboration of a personalised training programme.
• Healthy Aging Lifestyle Education (HALE)
The healthy aging lifestyle education programme will be based on a workshop series. Participants will receive information on a variety of topics of relevance to older adults (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop.

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident of major mobility disability	Incident inability to complete the 400-metre walk test (incidence of major mobility disability)	36 months
Secondary	Changes in lower extremity physical performance	Changes in short physical performance battery (SPPB) summary score	36 months
Secondary	Changes in upper extremity muscle strength	Changes in handgrip strength test performance (kg)	36 months
Secondary	Changes in functional status (activities of daily living)	Changes in Activities of Daily Living (ADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)	36 months
Secondary	Changes in functional status (instrumental activities of daily living)	Changes in Instrumental Activities of Daily Living (IADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)	36 months
Secondary	Changes in crude appendicular lean mass	Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry	36 months
Secondary	Changes in body mass index-adjusted appendicular lean mass	Changes in body mass index-adjusted appendicular lean mass (adimensional) by Dual Energy X-Ray Absorptiometry	36 months
Secondary	Persistent mobility disability	Inability to complete the 400-metre walk test at two consecutive semiannual visits	36 months
Secondary	Changes in body weight	Changes in body weight (kg)	36 months
Secondary	Changes in body mass index	Changes in body mass index (kg/m^2)	36 months
Secondary	Changes in mid-arm circumference	Changes in mid-arm circumference (cm)	36 months
Secondary	Changes in waist circumference	Changes in waist circumference (cm)	36 months
Secondary	Changes in hip circumference	Changes in hip circumference (cm)	36 months
Secondary	Changes in calf circumference	Changes in calf circumference (cm)	36 months
Secondary	Changes in nutritional status	Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score	36 months
Secondary	Changes in cognitive function	Changes in Mini Mental State Examination (MMSE) score	36 months
Secondary	Changes in mood	Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score	36 months
Secondary	Incidence of self-reported falls	Number of falls assessed by questionnaires	36 months
Secondary	Incidence of injurious falls	Number of injurious falls assessed by questionnaires	36 months
Secondary	Changes in quality of life	Changes in EuroQoL-5D (EQ5D) score	36 months
Secondary	Changes in the use of healthcare services	Health economics questionnaire	36 months
Secondary	All-cause mortality	Mortality rate	36 months
Secondary	Cost effectiveness	Cost effectiveness analysis	36 months