Physical Activity Intervention in ELderly Patients With Myocardial INfarction

NCT04183465 | Active Not Recruiting DMC

• 1 other identifier: 376/2019/Sper/AOUFe
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 7

Brief Summary

Elderly patients presenting with myocardial infarction (MI) are the highest risk population with the worst prognosis. No trial has ever been designed to optimize their outcome through a systematic improvement of their physical performance. Cardiac rehabilitation demonstrated to improve prognosis of patients after MI. However, real-life data shows that older patients are not referred to rehabilitation centers or they have low rate of attendance because of the high number of rehabilitation sessions and of logistic problems. So, data about effectiveness of rehabilitation programs in older MI patients is lacking. The "Physical Activity Intervention for Elderly Patients with Reduced Physical Performance after acute coronary syndrome (HULK)" pilot study (NCT03021044) enrolled older MI patients and it demonstrated the feasibility and effectiveness of an early, tailored and low-cost physical activity intervention in terms of physical performance assessed by Short Physical Performance Battery (SPPB) score, that is strongly related to prognosis. The HULK study was focused on exercise training and not powered for hard endpoints. If a multi-domain lifestyle intervention in an adequately powered study may further improve prognosis is unknown. Thus, the investigator's hypothesis for the PIpELINe trial is that an early, tailored and low-cost multi-domain lifestyle intervention may improve prognosis of older MI patients compared to health education alone. The primary outcome is a composite of 1-year cardiovascular death and hospital readmission for cardiovascular cause.

Conditions

Myocardial Infarction; Aging

Outcome Measures

Primary Outcomes (1)

• Cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause

  To assess the superiority of the early and tailored physical activity intervention over health education alone in terms of 1-year composite endpoint of cardiovascular death plus hospital readmission for cardiovascular cause.

  1-year

Secondary Outcomes (21)

• Cumulative occurrence of all-cause death

  1-year

• Cumulative occurrence of all-cause death

  3-year

• Cumulative occurrence of cardiovascular death

  1-year

• Cumulative occurrence of cardiovascular death

  3-year

• Cumulative occurrence of hospital readmission for cardiovascular cause

  1-year

Other Outcomes (12)

• Short Physical Performance Battery

  6-month

• Short Physical Performance Battery

  1-year

• Short Physical Performance Battery

  3-year

Study Arms (2)

Health Education

ACTIVE COMPARATOR

All patients randomized to health education received a single in-person visit, one month post discharge, which included a 30-minute counselling session, supported by educational materials and tailoring of the medical treatment. The educational material provided standardized recommendations on diet, smoking cessation, and physical activity. Quality of life, functional capacity and home physical activity are assessed by proper tools.

Other: Health Education

Multi-domain lifestyle intervention

EXPERIMENTAL

All patients randomized to experimental arm will receive diet counselling, aggressive control of CV risk factors, smoke cessation program and exercise training. The physical activity (PA) intervention will start the program with a supervised PA session immediately after the inclusion visit. Quality of life, functional capacity and daily activities will be assessed by proper tools. The program provides 6 supervised PA sessions (30, 60, 90, 180, 270 and 360 days after hospital discharge \[T0\]). At the end of each supervised session, calisthenics exercises derived from Otago Exercise Program are prescribed.

Other: Multi-domain lifestyle intervention

Interventions

Health Education OTHER

Current gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients

Health Education

Multi-domain lifestyle intervention OTHER

The intervention includes diet counselling, smoke cessation program, aggressive CV risk control and PA intervention. The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members.

Multi-domain lifestyle intervention

Eligibility Criteria

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

You may qualify if:

• Patients ≥65 years
• Hospital admission for myocardial infarction
• Invasive management during index hospitalization including coronary artery angiography (± percutaneous coronary revascularization)
• SPPB value 4-9 at 1-month visit after hospital discharge
• Informed consent

You may not qualify if:

• Multivessel coronary artery disease or left main coronary artery disease candidate to surgical revascularization
• Planned staged percutaneous coronary intervention (PCI)
• Non-cardiovascular co-morbidity reducing life expectancy to \< 1 year
• Any factor precluding 1-year follow-up
• Severe aortic or mitral disease
• Ejection fraction \<30%
• Chronic heart failure New York Heart Association (NYHA) III-IV
• Severe cognitive impairment (SPMSQ \<4)
• Impossibility to do physical activity due to physical impairment

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Azienda Usl di Bologna: collaborator
• Azienda Unita Sanitaria Locale di Piacenza: collaborator

Study Sites (7)

Medicina dello Sport SSD

Bologna, BO, Italy

Location

Centro Studi Biomedici applicati allo Sport, Ferrara

Ferrara, FE, Italy

Location

Ospedale Guglielmo da Saliceto, Piacenza

Piacenza, PC, Italy

Location

UO Cardiologia, Ospedale Maggiore

Bologna, Italy

Location

Cardiology Unit

Ferrara, Italy

Location

Cardiologia Riabilitativa, AUSL d Ferrara

Lagosanto, Italy

Location

Medicina dello Sport, AUSL Piacenza

Piacenza, Italy

Location

Related Publications (2)

• Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pavasini R, Vitali F, Gibiino F, Campana R, Boccadoro A, Scala A, Canovi L, Amantea V, Matese C, Berloni ML, Piva T, Zerbini V, Cardelli LS, Pasanisi G, Mazzoni G, Casella G, Grazzi G, Campo G. Multi-domain lifestyle intervention in older adults after myocardial infarction: rationale and design of the PIpELINe randomized clinical trial. Aging Clin Exp Res. 2023 May;35(5):1107-1115. doi: 10.1007/s40520-023-02389-9. Epub 2023 Mar 25.

  PMID: 36964866 RESULT

• Tonet E, Raisi A, Zagnoni S, Chiaranda G, Pasanisi G, Aschieri D, D'Intino PE, Pavasini R, Cimaglia P, Campana R, Vitali F, Piva T, Casella G, Caglioni S, Zerbini V, Bugani G, Cocco M, Menegatti E, De Raffele M, Mandini S, Martella D, Pesenti N, Mazzoni G, Biscaglia S, Volpato S, Grazzi G, Campo G; PIpELINe Trial Investigators. Multidomain Rehabilitation for Older Patients with Myocardial Infarction. N Engl J Med. 2025 Sep 11;393(10):973-982. doi: 10.1056/NEJMoa2502799. Epub 2025 Aug 29.

  PMID: 40879431 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The members of the Clinical Event Committee will be blinded to randomization arm during all phases of the adjudications of the adverse events
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 3, 2019
• Study Start: March 27, 2020
• Primary Completion: November 30, 2024
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of the main findings
• Access Criteria: It will be necessary a formal request to the Executive Committee of the study. The request will be analyzed and considered for acceptance

Locations

IT (7)