An interventional study of Exercise, dietary and educational program in Type 2 Diabetes Mellitus, sponsored by Hospital Universitario Getafe. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Hospital Universitario Getafe · Not applicable, Interventional, and Prevention
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: 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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 986 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hospital Universitario Getafe is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subjects undergo usual standard of care
Intervention with exercise, dietary and educational programs
Behavioral: Exercise, dietary and educational program
Changes in summary ordinal score on the Short Physical Performance Battery test
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.
Time frame: 2 years
Lawton Instrumental Activity of Daily Living (IADL) scale
Time frame: 2 years
Barthel index of activities of daily living
Time frame: 2 years
Euro-Quality of Life (QoL) index
Time frame: 2 years
Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,
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).
Time frame: 2 years
Symptomatic hypoglycaemia
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)
Time frame: 2 years
Hospital admissions
Episodes of hospital admission (i.e., any admission involving an overnight stay)
Time frame: 2 years
Episodes of permanent institutionalization
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).
Time frame: 2 years
Caregiver Strain Index
Burden of the carer, as assessed by the modified Caregiver Strain Index
Time frame: 2 years
Mortality
Time frame: 2 years
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Getafe