Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Behavioral: Exercise, dietary and educational program
- Registration Number
- NCT01654341
- Lead Sponsor
- Hospital Universitario Getafe
- Brief Summary
The MID-Frail STUDY project focuses on the use of interventions designed to improve functional status and enhance quality of life (rather than traditional treatments such as glucose- and blood pressure- lowering) by acting on the mechanisms involved in producing frailty and its progression to adverse outcomes.
- Detailed Description
Detailed Description: Subjects enrolled in the main study will also be invited to join the following sub-studies:
GENEFRAIL: this sub-study aims to determine the polymorphisms of several genes associated to frailty, in order to establish its predictive value for developing disability and response to treatment as well METABOFRAIL: this sub-study aims to investigate the metabolomic profile of frail and pre-frail patients. SARTRAIN: the combination of the assessment tools used in SARTRAIN (ARFI US, MRI, posturographic measurements) will provide a comprehensive study of the structural and functional characteristics of muscle and adjacent tissues and their change with time and the intervention. MID- POW: this sub-study aims to investigate changes in muscle power.
The project also include an randomized controlled ancillary study: SENSOLE for which the aim is to investigate the potential effects of vibrating insoles device on gait and posture.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 986
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Exercise, dietary and educational program Intervention with exercise, dietary and educational programs
- Primary Outcome Measures
Name Time Method Changes in summary ordinal score on the Short Physical Performance Battery test 2 years The Short Physical Performance Battery (SPPB) is a simple test to measure lower extremity function using tasks that mimic daily activities. The SPPB examines 3 areas of lower extremity function; static balance, gait speed, and getting in and out of a chair. These areas represent essential tasks important for independent living and are thus an important outcome measure for patients with cardiovascular and pulmonary disease.
- Secondary Outcome Measures
Name Time Method Symptomatic hypoglycaemia 2 years Episodes of symptomatic hypoglycaemia (i.e., a recorded blood sugar less than 4 mmol/L, or symptoms or signs attributed to low blood sugar and responding to appropriate treatment)
Lawton Instrumental Activity of Daily Living (IADL) scale 2 years Caregiver Strain Index 2 years Burden of the carer, as assessed by the modified Caregiver Strain Index
Barthel index of activities of daily living 2 years Euro-Quality of Life (QoL) index 2 years Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, 2 years Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life, using an economic model embracing the direct health-related costs (in-patient, out-patient, pharmaceutical, etc), formal care costs (home care, respite care, day centers, etc) and the informal care costs (carer).
Hospital admissions 2 years Episodes of hospital admission (i.e., any admission involving an overnight stay)
Mortality 2 years Episodes of permanent institutionalization 2 years Episodes of permanent institutionalization (i.e., permanent move to any care setting other than the patient's own home, where paid staff are available to provide care if needed at any time during the day or night).
Trial Locations
- Locations (1)
Hospital Universitario de Getafe
🇪🇸Madrid, Getafe, Spain