Multi-Modal Intervention In Frail And Prefrail Older People With Type 2 Diabetes

NCT01654341 | Completed

• 2 other identifiers: MID-Frail278803-2
• Study Type: interventional
• Target: 986
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• 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

  2 years

• Economic costs/healthcare expenditure due to diabetes and its impact on disability and quality of life,

  2 years

• Symptomatic hypoglycaemia

  2 years

Study Arms (2)

Usual Care Group

NO INTERVENTION

Subjects undergo usual standard of care

Intervention Group

EXPERIMENTAL

Intervention with exercise, dietary and educational programs

Behavioral: Exercise, dietary and educational program

Interventions

Exercise, dietary and educational program BEHAVIORAL

Intervention Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead
• Cardiff University: collaborator
• Igen Biotech SL: collaborator
• University Hospital, Bordeaux: collaborator
• Hexabio Sarl: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University Hospital, Toulouse: collaborator
• University of Ulm: collaborator
• University Ghent: collaborator
• University of Castilla-La Mancha: collaborator
• Univerzita Karlova v Praze: collaborator
• Niche Science & Technology Ltd: collaborator
• Catholic University of the Sacred Heart: collaborator
• Vrije Universiteit Brussel: collaborator
• Diabetes Frail Ltd: collaborator

Study Sites (1)

Hospital Universitario de Getafe

Madrid, Getafe, 28905, Spain

Location

Related Publications (3)

• 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.

  PMID: 39954533 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.

  PMID: 31316984 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.

  PMID: 24456998 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exercise; Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Leocadio Rodríguez Mañas, MD

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2012
• First Posted: July 31, 2012
• Study Start: December 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 26, 2019

Record last verified: 2019-03

Locations

ES (1)