| ID | Type | Description | Link |
|---|---|---|---|
| 278803-2 | Other Identifier | European Commission: CORDIS: Seventh Framework Programme (FP7) |
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| Name | Class |
|---|---|
| Cardiff University | OTHER |
| Igen Biotech SL | UNKNOWN |
| University Hospital, Bordeaux | OTHER |
| Hexabio Sarl |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Group | No Intervention | Subjects undergo usual standard of care | |
| Intervention Group | Experimental | Intervention with exercise, dietary and educational programs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise, dietary and educational program | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lawton Instrumental Activity of Daily Living (IADL) scale | 2 years | |
| Barthel index of activities of daily living | 2 years | |
| Euro-Quality of Life (QoL) index |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leocadio Rodríguez Mañas, MD | Hospital Universitario de Getafe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Getafe | Madrid | Getafe | 28905 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39954533 | Derived | Laosa O, Topinkova E, Bourdel-Marchasson I, Vellas B, Izquierdo M, Paolisso G, Hardman T, Zeyfang A, Pedraza L, Carnicero JA, Rodriguez-Manas L, Sinclair AJ; MIDFRAIL consortium. Long-term frailty and physical performance transitions in older people with type-2 diabetes. The MIDFRAIL randomized clinical study. J Nutr Health Aging. 2025 Apr;29(4):100512. doi: 10.1016/j.jnha.2025.100512. Epub 2025 Feb 14. | |
| 31316984 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004032 | Diet |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| UNKNOWN |
| University of Campania Luigi Vanvitelli | OTHER |
| University Hospital, Toulouse | OTHER |
| University of Ulm | OTHER |
| University Ghent | OTHER |
| University of Castilla-La Mancha | OTHER |
| Univerzita Karlova v Praze | OTHER |
| Niche Science & Technology Ltd | UNKNOWN |
| Catholic University of the Sacred Heart | OTHER |
| Vrije Universiteit Brussel | OTHER |
| Diabetes Frail Ltd | OTHER |
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| 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). | 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) | 2 years |
| Hospital admissions | Episodes of hospital admission (i.e., any admission involving an overnight stay) | 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). | 2 years |
| Caregiver Strain Index | Burden of the carer, as assessed by the modified Caregiver Strain Index | 2 years |
| Mortality | 2 years |
| Derived |
| Regueme SC, Cowtan C, Sedgelmaci MY, Kelson M, Poustis J, Rodriguez-Manas L, Sinclair AJ, Dallaudiere B, Bourdel-Marchasson I. A Therapeutic Insole Device for Postural Stability in Older People With Type 2 Diabetes. A Feasibility Study (SENSOLE Part I). Front Med (Lausanne). 2019 Jun 27;6:127. doi: 10.3389/fmed.2019.00127. eCollection 2019. |
| 24456998 | Derived | Rodriguez-Manas L, Bayer AJ, Kelly M, Zeyfang A, Izquierdo M, Laosa O, Hardman TC, Sinclair AJ, Moreira S, Cook J; MID-Frail Consortium. An evaluation of the effectiveness of a multi-modal intervention in frail and pre-frail older people with type 2 diabetes--the MID-Frail study: study protocol for a randomised controlled trial. Trials. 2014 Jan 24;15:34. doi: 10.1186/1745-6215-15-34. |
| D004700 | Endocrine System Diseases |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |