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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 May 2021
• Main ID: NCT03021044
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: University Hospital of Ferrara
• Public title: Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome HULK
• Scientific title: Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome: a Randomized Clinical Trial (The HULK Pilot Study).
• Date of first enrolment: January 2017
• Target sample size: 235
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03021044
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion Criteria:

- informed consent

- age =70 years old

- hospital admission for acute coronary syndrome

- coronary artery angiography and successfully percutaneous coronary revascularization

- result of the short physical performance battery test at the inclusion visit between 4
and 9

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Acute Coronary Syndrome

Intervention(s)

Other: standard of care

Other: physical activity intervention

Primary Outcome(s)

Physical performance [Time Frame: 6 months]

Secondary Outcome(s)

cardiac adverse events [Time Frame: 2 years]

clinical adverse events [Time Frame: 2 years]

Physical performance [Time Frame: 1 year]

Physical performance [Time Frame: 3 years]

cardiac adverse events [Time Frame: 3 years]

clinical adverse events [Time Frame: 3 years]

Physical performance [Time Frame: 2 years]

cardiac adverse events [Time Frame: 1 year]

clinical adverse events [Time Frame: 1 year]

Secondary ID(s)

161098

Source(s) of Monetary Support

Please refer to primary and secondary sponsors