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Trial record 1 of 5 for:    hulk
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Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome (HULK)

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ClinicalTrials.gov Identifier: NCT03021044
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: physical activity intervention Other: standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity Intervention for Patients With Reduced Physical Performance After Acute Coronary Syndrome: a Randomized Clinical Trial (The HULK Pilot Study).
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
STANDARD OF CARE
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
30, 60, 90 and 120 days after hospital discharge a clinical visit with correct style life recommendation

Experimental: PHYSICAL ACTIVITY INTERVENTION
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
30, 60, 90 and 120 days after hospital discharge a clinical visit and session of physical activity training and program




Primary Outcome Measures :
  1. Physical performance [ Time Frame: 6 months ]
    result of the short physical performance battery test


Secondary Outcome Measures :
  1. Physical performance [ Time Frame: 1 year ]
    result of the short physical performance battery test

  2. Physical performance [ Time Frame: 2 years ]
    result of the short physical performance battery test

  3. Physical performance [ Time Frame: 3 years ]
    result of the short physical performance battery test

  4. clinical adverse events [ Time Frame: 1 year ]
    cumulative occurrence of all-cause mortality and all-cause hospital readmission

  5. clinical adverse events [ Time Frame: 2 years ]
    cumulative occurrence of all-cause mortality and all-cause hospital readmission

  6. clinical adverse events [ Time Frame: 3 years ]
    cumulative occurrence of all-cause mortality and all-cause hospital readmission

  7. cardiac adverse events [ Time Frame: 1 year ]
    cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause

  8. cardiac adverse events [ Time Frame: 2 years ]
    cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause

  9. cardiac adverse events [ Time Frame: 3 years ]
    cumulative occurrence of cardiovascular death and hospital readmission for cardiovascular cause


Other Outcome Measures:
  1. compliance to antiplatelet agents [ Time Frame: 1 year ]
    percentage of patients maintaining dual antiplatelet regimen

  2. physical training and session side effects [ Time Frame: 6 months ]
    cumulative occurrence of any complications or adverse events during the physical activity training and session



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021044


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Ospedale Guglielmo da Saliceto
Piacenza, Italy
Ospedale Santa maria delle Croci
Ravenna, Italy
Sponsors and Collaborators
University Hospital of Ferrara
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gianluca Campo, Interventional cardiologist and Associate Professor, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03021044    
Other Study ID Numbers: 161098
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases