A RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF A MULTI-MODAL INTERVENTION IN FRAIL AND PREFRAIL OLDER PEOPLE WITH TYPE 2 DIABETES ON FRAILTY AND QUALITY OF LIFE: THE MID-Frail STUDY
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Hospital Universitario Getafe
- Enrollment
- 986
- Locations
- 1
- Primary Endpoint
- Changes in summary ordinal score on the Short Physical Performance Battery test
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Changes in summary ordinal score on the Short Physical Performance Battery test
Time Frame: 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 Outcomes
- Symptomatic hypoglycaemia(2 years)
- Lawton Instrumental Activity of Daily Living (IADL) scale(2 years)
- Caregiver Strain Index(2 years)
- 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)
- Hospital admissions(2 years)
- Mortality(2 years)
- Episodes of permanent institutionalization(2 years)