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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 986
- Locations
- 2
- Primary Endpoint
- Changes in summary ordinal score on the Short Physical Performance Battery test
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is willing and able to give written informed consent for participation in the study.
- •Subjects aged 70 years or older, with a diagnosis of type 2 diabetes mellitus for at least 2 years.
- •Require to fulfill Fried ́s criteria for frail or pre-frail individuals.
Exclusion Criteria
- •Barthel score lower than 60 points.
- •Inability to carry out SPPB test (total score=0).
- •Mini Mental State Examination score less than 20 points.
- •Subjects unwilling or unable to consent or unable to participate safely in intervention program.
- •Previous history of myocardial infarction within 6 months, unstable angina or congestive heart failure in III-IV NYHA stage.
- •Clinically instable patients in the clinical judgment of the investigator.
- •Terminal illness (life expectancy < 6 months).
- •Any other condition that, in the clinical judgment of the investigator, means that it would not in the patient's best interests to enter the study.
- •Current participation in clinical trial or any other investigational study.
Arms & Interventions
Usual Care Group
Subjects undergo usual standard of care
Intervention Group
Intervention with exercise, dietary and educational programs
Intervention: Exercise, dietary and educational program (Behavioral)
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)