Frail ElderlyMEFAPNCT03568084
Effectiveness of an Intervention in Multicomponent Exercise in Patients Over 70 Years in Primary Care
A study testing MEFAP in people with Frail Elderly and Physical Activity, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Frail Elderly, Physical Activity
- What is being tested?
- MEFAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Intervention in Multicomponent Exercise (MEFAP) in Patients Over 70 Years in Primary Care: Reversibility of Prefrailty
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.
Read the detailed description
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.
Location: primary care setting (Madrid Region).
Population: non-dependent and pre-frailty patients ≥ 70 years old, who attend the health centers included in the study.
Design: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
Intervention: 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).
Main measures: Main variable: pre-frailty according to Fried phenotype. Secondary variables: sociodemographic, clinical and function variables; adherence, user satisfaction, quality of life.
Analysis: 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) at the end of the intervention, 6 months after the intervention and one year after the intervention. Cumulative incidence, Relative Risk and Number Needed to Treat with a 95% Confidence Interval. A Generalized Estimating Equation logit model will be adjusted to analyze the associated factors.
- Conditions
- Frail Elderly, Physical Activity
- Being tested
- MEFAP, control usual practice
- Keywords
- elderly, physical activity, exercise, frailty
- Medical subject headings
- Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEFAPOther
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).
control usual practiceOther
Individuals allocated to this arm, will be look after as usual in their health Centers.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: control usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: one year after the intervention.
Secondary outcomes (5)
Change from baseline frail elderly level at at the end of the intervention (12 weeks)
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)
Measured: at the end of the intervention (12 weeks)
Change from baseline frail elderly level at at the at 6 month
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)
Measured: 6 month after the intervention
Adherence to intervention
degree of adherence to the program (number of sessions with assistance)
Measured: at the end of the intervention (12 weeks)
Euroqol utilities
Euroqol descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)
Measured: at the end of the intervention (12 weeks),
Visual Analog Scale
A Visual Analog Scale with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)
Measured: at the end of the intervention (12 weeks),
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018
- Primary completion1 Feb 2020
- Study completion10 Mar 2020
Why it stopped: SARS-CoV-2 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gerencia de Atención Primaria, Madrid
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568084
- Sponsor's protocol ID
- PI17/01889
- Acronym
- MEFAP
- Status last verified
- Apr 2022
- First submitted
- 24 May 2018
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30691405
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention in Multicomponent Exercise (MEFAP) in Patients Over 70 Years in Primary Care: Reversibility of Prefrailty
- ClinicalTrials.gov ID
- NCT03568084
- Acronym / sponsor ID
- MEFAP / PI17/01889
- Conditions
- Frail Elderly, Physical Activity
- Keywords
- elderly, physical activity, exercise, frailty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SARS-CoV-2 Pandemic
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Gerencia de Atención Primaria, MadridOther government
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Location: primary care setting (Madrid Region).
Population: non-dependent and pre-frailty patients ≥ 70 years old, who attend the health centers included in the study.
Design: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
Intervention: 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).
Main measures: Main variable: pre-frailty according to Fried phenotype. Secondary variables: sociodemographic, clinical and function variables; adherence, user satisfaction, quality of life.
Analysis: 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) at the end of the intervention, 6 months after the intervention and one year after the intervention. Cumulative incidence, Relative Risk and Number Needed to Treat with a 95% Confidence Interval. A Generalized Estimating Equation logit model will be adjusted to analyze the associated factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
| Arm | Type | Receives |
|---|---|---|
| MEFAP | Experimental | Other: MEFAP, Other: control usual practiceMEFAP (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). |
| Control: usual practice | Active comparator | Other: control usual practiceNo intervention. Individuals allocated to this arm, will be look after as usual in their health Centers. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEFAPmulticomponent 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). | Other | MEFAP |
| control usual practiceIndividuals allocated to this arm, will be look after as usual in their health Centers. | Other | Control: usual practice, MEFAP |
Primary outcome
Change from baseline frail elderly level at one year
Time frame: one year after the intervention.
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)
5 secondary outcomes
Change from baseline frail elderly level at at the end of the intervention (12 weeks)
Time frame: at the end of the intervention (12 weeks)
Change from baseline frail elderly level at at the at 6 month
Time frame: 6 month after the intervention
Adherence to intervention
Time frame: at the end of the intervention (12 weeks)
Euroqol utilities
Time frame: at the end of the intervention (12 weeks),
Visual Analog Scale
Time frame: at the end of the intervention (12 weeks),
Results and safety
The study was stopped early (reason given: SARS-CoV-2 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Derived from this study: PubMed 30691405Castell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEFAP in people with Frail Elderly and Physical Activity, run by Gerencia de Atención Primaria, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: SARS-CoV-2 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline frail elderly level at one year (time frame: one year after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03568084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.