Effectiveness of an Intervention in Multicomponent Exercise in Patients Over 70 Years in Primary Care

NCT03568084 | Terminated DMC

• 1 other identifier: PI17/01889
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To evaluate the effect of a multicomponent physical activity program, compared with the usual medical practice, to reverse prefrailty by Fried in people over 70 years, one year after the end of the intervention.

Conditions

Frail Elderly; Physical Activity

Keywords

elderly; physical activity; exercise; frailty

Outcome Measures

Primary Outcomes (1)

• Change from baseline frail elderly level at one year

  It will be carried out an analysis by intention to treat comparing the retrogression from pre-frailty (1 or 2 Fried criteria) to robust (0 Fried criteria)

  one year after the intervention.

Secondary Outcomes (5)

• Change from baseline frail elderly level at at the end of the intervention (12 weeks)

  at the end of the intervention (12 weeks)

• Change from baseline frail elderly level at at the at 6 month

  6 month after the intervention

• Adherence to intervention

  at the end of the intervention (12 weeks)

• Euroqol utilities

  at the end of the intervention (12 weeks),

• Visual Analog Scale

  at the end of the intervention (12 weeks),

Study Arms (2)

MEFAP

EXPERIMENTAL

MEFAP (multicomponent physical activity program) for 12 weekly sessions of an hour and a half which includes 1) briefing 2) exercises for improving aerobic resistance, muscle strength, proprioception-balance and flexibility and 3) delivery of exercise chart to do at home (two times per week).

Other: MEFAP; Other: control usual practice

Control: usual practice

ACTIVE COMPARATOR

No intervention. Individuals allocated to this arm, will be look after as usual in their health Centers.

Other: control usual practice

Interventions

MEFAP OTHER

multicomponent physical activity program (MEFAP) with 12 weekly sessions of an hour and a half which includes 1) briefing 2) exercises for improving aerobic resistance, muscle strength, proprioception-balance and flexibility and 3) delivery of exercise chart to do at home (two times per week).

MEFAP

control usual practice OTHER

Individuals allocated to this arm, will be look after as usual in their health Centers.

Control: usual practice; MEFAP

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals aged \>70 years with a Barthel test ≥90 and pre-frailty (1-2 Fried phenotype frailty criteria).
• For Health Care Centers: Centers who deliver patient to Physiotherapy Units who participate in this Project. Centers where at least two General Practitioners accept to participate in the Project.

You may not qualify if:

• Moderate to severe dependency (impairment) for daily living activities (Barthel test \<90)
• Enable to achieve Health Care Center for any reason.
• Moderate to severe cognitive impairment (MEC 35 Lobo≤21)
• Severe illness that contraindicates to practice exercise by medical criteria: recent hearth attack (6 months), not controlled arrhythmia, severe hearth valvular disease, not controlled arterial hypertension (systolic blood pressure\>180/diastolic blood pressure\>100), severe heart failure, severe respiratory failure, diabetes mellitus with frequent acute hypoglycemia, any other circumstance that makes the individual unable to do exercise under medical criteria.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Maria Victoria Castell

Madrid, 28035, Spain

Location

Related Publications (1)

• Castell MV, Gutierrez-Misis A, Sanchez-Martinez M, Prieto MA, Moreno B, Nunez S, Triano R, de Antonio MP, Mateo C, Cano MD, Garrido A, Julian R, Polentinos E, Rodriguez-Barrientos R, Otero Puime A; MEFAP Group. Effectiveness of an intervention in multicomponent exercise in primary care to improve frailty parameters in patients over 70 years of age (MEFAP-project), a randomised clinical trial: rationale and study design. BMC Geriatr. 2019 Jan 28;19(1):25. doi: 10.1186/s12877-018-1024-8.

  PMID: 30691405 DERIVED

MeSH Terms

Conditions

Motor Activity; Frailty

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 26, 2018
• Study Start: July 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: March 10, 2020
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

ES (1)