Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome

NCT03021044 | Completed DMC

• 1 other identifier: 161098
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE AND OBJECTIVE OF THE STUDY Patients with low functional capacity (frail patients) with cardiovascular disease, in particular those undergoing invasive procedures or suffering from coronary artery disease, have a much higher adverse events, death and re-hospitalizations. and complications, suggesting the need for a more accurate functional stratification and a more careful evaluation of the risk/benefit ratio of some invasive procedures. An early and ad hoc physical activity intervention could be improve functional autonomy of these patients early after discharge with benefit on long-term outcome. The present study is performed to assess the impact, evaluated by Short Physical Performance Battery (SPPB), of a program of physical activity early after discharge in elderly patients aged 75 years and older with low physical performance. This is an interventional, multicenter, prospective, randomized, phase III study. The present study is expected to enroll elderly patients admitted to hospital for acute coronary syndrome undergoing percutaneous coronary angioplasty and stratified with SPPB score predischarge. At the moment of discharge there will be a screening: patients with SPPB score 0-2 o 10-12 will be exclusively followed up by clinical visit every year. Patients with SPPB score 3-9 will be evaluated during the inclusion visit when SPPB will be repeated. If SPPB score will be 0-3 or 10-12, patients will be considered screening failure and will be followed up by clinical visit; patients with SPPB score between 4 to 9 will be randomized to standard of care (see below) or to an ad hoc physical activity program (see below). The aim of the study is to demonstrate 6 months later an improvement in the SPPB score (at least 1 point) in patients randomized to physical activity intervention versus patients randomized to standard of care. All patients will be evaluated until 3 years after randomization.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Physical performance

  result of the short physical performance battery test

  6 months

Secondary Outcomes (9)

• Physical performance

  1 year

• Physical performance

  2 years

• Physical performance

  3 years

• clinical adverse events

  1 year

• clinical adverse events

  2 years

Other Outcomes (2)

• compliance to antiplatelet agents

  1 year

• physical training and session side effects

  6 months

Study Arms (2)

STANDARD OF CARE

OTHER

The standard of care group will be recommended about medications and a correct life style (physical activity, low salt and low fat diet, no smoking) in order to prevent cardiovascular events. In this 15-minutes talk study doctor will explain to patients and relatives the importance of aerobic physical activity (30-60 minutes daily, moderate intensity, for example speedy walking, for at least 5 days/weekly) with the aim of reducing cardiovascular risk. Patients will also receive a brochure with clear explanations. Study doctor and study coordinator will be helpful for any question and they will ensure that patients and relatives understand the importance of physical activity for cardiovascular health.

Other: standard of care

PHYSICAL ACTIVITY INTERVENTION

EXPERIMENTAL

Besides standard of care, the experimental group will participate to a program of physical activity intervention. Following hospital discharge, participants in stable clinical conditions will be referred by their cardiologist to the exercise-based secondary prevention program. All exercise testing and training sessions will be performed without discontinuing the prescribed medications. On admission to the program, and quarterly during follow-up, each patient will perform a 1-km treadmill walk test as previously described (1k-TWT).

Other: physical activity intervention

Interventions

physical activity intervention OTHER

30, 60, 90 and 120 days after hospital discharge a clinical visit and session of physical activity training and program

PHYSICAL ACTIVITY INTERVENTION

standard of care OTHER

30, 60, 90 and 120 days after hospital discharge a clinical visit with correct style life recommendation

STANDARD OF CARE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• informed consent
• age ≥70 years old
• hospital admission for acute coronary syndrome
• coronary artery angiography and successfully percutaneous coronary revascularization

You may not qualify if:

• chronic heart failure (new york heart association classification III-IV)
• left ventricle ejection fraction \<30%.
• severe aortic or mitral valvulopathy
• three vessel coronary artery disease or left main coronary artery disease requiring surgical coronary revascularization
• need of staged percutaneous coronary intervention
• severe cognitive impairment (defined as short portable mental status questionnaire \< 4)
• physical limitation/impairment not permitting physical activity training annd program
• life expectancy \<12 months

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (3)

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

Location

Ospedale Guglielmo da Saliceto

Piacenza, Italy

Location

Ospedale Santa maria delle Croci

Ravenna, Italy

Location

Related Publications (4)

• Raisi A, Zerbini V, Myers J, Piva T, Campo G, Mazzoni G, Grazzi G, Mandini S. A Novel Motivational Approach in the Management of Older Patients With Cardiovascular Disease. J Cardiopulm Rehabil Prev. 2023 Jul 1;43(4):309-310. doi: 10.1097/HCR.0000000000000791. Epub 2023 Apr 5. No abstract available.

  PMID: 37014940 DERIVED

• Erriquez A, Pavasini R, Biscaglia S, Tebaldi M, Tonet E, Maietti E, Cimaglia P, Grazzi G, Scoccia A, Cardelli LS, Verardi FM, Morelli C, Campana R, Rubboli A, Mazzoni G, Volpato S, Ferrari R, Campo G. The impact of periprocedural myocardial infarction on mortality in older adults with non-ST-segment elevation acute coronary syndrome: a pooled analysis of the FRASER and HULK studies. J Cardiovasc Med (Hagerstown). 2021 Jul 1;22(7):546-552. doi: 10.2459/JCM.0000000000001146.

  PMID: 34076602 DERIVED

• Campo G, Tonet E, Chiaranda G, Sella G, Maietti E, Bugani G, Vitali F, Serenelli M, Mazzoni G, Ruggiero R, Villani G, Biscaglia S, Pavasini R, Rubboli A, Campana R, Caglioni S, Volpato S, Myers J, Grazzi G. Exercise intervention improves quality of life in older adults after myocardial infarction: randomised clinical trial. Heart. 2020 Nov;106(21):1658-1664. doi: 10.1136/heartjnl-2019-316349. Epub 2020 Mar 6.

  PMID: 32144189 DERIVED

• Tonet E, Maietti E, Chiaranda G, Vitali F, Serenelli M, Bugani G, Mazzoni G, Ruggiero R, Myers J, Villani GQ, Corvi U, Pasanisi G, Biscaglia S, Pavasini R, Lucchi GR, Sella G, Ferrari R, Volpato S, Campo G, Grazzi G. Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial. BMC Cardiovasc Disord. 2018 May 21;18(1):98. doi: 10.1186/s12872-018-0839-8.

  PMID: 29783928 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional cardiologist and Associate Professor

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 13, 2017
• Study Start: January 1, 2017
• Primary Completion: October 30, 2018
• Study Completion: April 28, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)