Multicomponent Intervention for Physical Frailty and Sarcopenia
- Conditions
- Sarcopenia
- Interventions
- Other: Healthy Aging Lifestyle Education (HALE)Other: Multicomponent intervention (MCI)
- Registration Number
- NCT02582138
- Lead Sponsor
- Catholic University of the Sacred Heart
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Aging Lifestyle Education (HALE) Healthy Aging Lifestyle Education (HALE) The health aging lifestyle education programme will be based on workshops. Participants will receive information on a variety of topics of relevance to older persons (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. Multicomponent intervention (MCI) Multicomponent intervention (MCI) The multicomponent intervention will include a physical activity programme, a nutritional intervention and an information and communications intervention.
- Primary Outcome Measures
Name Time Method Incident of major mobility disability 36 months Incident inability to complete the 400-metre walk test (incidence of major mobility disability)
- Secondary Outcome Measures
Name Time Method Persistent mobility disability 36 months Inability to complete the 400-metre walk test at two consecutive semiannual visits
Changes in lower extremity physical performance 36 months Changes in short physical performance battery (SPPB) summary score
Changes in nutritional status 36 months Changes in Mini Nutritional Assessment-Short Form (MNA-SF) score
Incidence of injurious falls 36 months Number of injurious falls assessed by questionnaires
All-cause mortality 36 months Mortality rate
Changes in mood 36 months Changes in 11-item Center for Epidemiological Studies - Depression (CES-D) scale score
Changes in crude appendicular lean mass 36 months Changes in crude in appendicular lean mass (kg) by Dual Energy X-Ray Absorptiometry
Changes in body mass index 36 months Changes in body mass index (kg/m\^2)
Changes in mid-arm circumference 36 months Changes in mid-arm circumference (cm)
Changes in hip circumference 36 months Changes in hip circumference (cm)
Changes in upper extremity muscle strength 36 months Changes in handgrip strength test performance (kg)
Changes in functional status (instrumental activities of daily living) 36 months Changes in Instrumental Activities of Daily Living (IADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)
Changes in waist circumference 36 months Changes in waist circumference (cm)
Changes in calf circumference 36 months Changes in calf circumference (cm)
Changes in body mass index-adjusted appendicular lean mass 36 months Changes in body mass index-adjusted appendicular lean mass (adimensional) by Dual Energy X-Ray Absorptiometry
Changes in cognitive function 36 months Changes in Mini Mental State Examination (MMSE) score
Changes in functional status (activities of daily living) 36 months Changes in Activities of Daily Living (ADL) score computed through a modified version of the Pepper Assessment Tool for Disability (PAT-D)
Changes in body weight 36 months Changes in body weight (kg)
Incidence of self-reported falls 36 months Number of falls assessed by questionnaires
Changes in quality of life 36 months Changes in EuroQoL-5D (EQ5D) score
Changes in the use of healthcare services 36 months Health economics questionnaire
Cost effectiveness 36 months Cost effectiveness analysis
Trial Locations
- Locations (1)
Catholic University of the Sacred Heart
🇮🇹Rome, Italy