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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,500
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.
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.
Catholic University of the Sacred Heart
Rome, Rome, Italy
RECRUITINGIncident of major mobility disability
Incident inability to complete the 400-metre walk test (incidence of major mobility disability)
Time frame: 36 months
Changes in lower extremity physical performance
Changes in short physical performance battery (SPPB) summary score
Time frame: 36 months
Changes in upper extremity muscle strength
Changes in handgrip strength test performance (kg)
Time frame: 36 months
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)
Time frame: 36 months
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)
Time frame: 36 months
Changes in crude appendicular lean mass
Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry
Time frame: 36 months
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
Time frame: 36 months
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Persistent mobility disability
Inability to complete the 400-metre walk test at two consecutive semiannual visits
Time frame: 36 months
Changes in body weight
Changes in body weight (kg)
Time frame: 36 months
Changes in body mass index
Changes in body mass index (kg/m\^2)
Time frame: 36 months
Changes in mid-arm circumference
Changes in mid-arm circumference (cm)
Time frame: 36 months
Changes in waist circumference
Changes in waist circumference (cm)
Time frame: 36 months
Changes in hip circumference
Changes in hip circumference (cm)
Time frame: 36 months
Changes in calf circumference
Changes in calf circumference (cm)
Time frame: 36 months
Changes in nutritional status
Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score
Time frame: 36 months
Changes in cognitive function
Changes in Mini Mental State Examination (MMSE) score
Time frame: 36 months
Changes in mood
Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score
Time frame: 36 months
Incidence of self-reported falls
Number of falls assessed by questionnaires
Time frame: 36 months
Incidence of injurious falls
Number of injurious falls assessed by questionnaires
Time frame: 36 months
Changes in quality of life
Changes in EuroQoL-5D (EQ5D) score
Time frame: 36 months
Changes in the use of healthcare services
Health economics questionnaire
Time frame: 36 months
All-cause mortality
Mortality rate
Time frame: 36 months
Cost effectiveness
Cost effectiveness analysis
Time frame: 36 months