What is the clinical evidence from this study?

Study design: RCT. Population: Systolic heart failure (NYHA III) with an implantable cardioverter-defibrillator (n=84). Intervention: 6-month individual rehabilitation program vs. Standard heart failure care. Primary outcome: VO2 peak at 18 months (ml/kg/min) (p=<0.05).

What question did this study set out to answer?

The study aimed to assess the effects of individualized training on physical capacity and cardiac parameters in patients with systolic heart failure and implanted ICD.

September 19, 2016Archives of Medical ScienceOpen Access

Improvement of exercise tolerance in cardiopulmonary testing with sustained safety after regular training in outpatients with systolic heart failure (NYHA III) and an implantable cardioverter-defibrillator. Prospective 18-month randomized study

Q: What are the key findings of this study?

A 6-month individual training program significantly improved exercise tolerance, including peak oxygen uptake (15.9 vs 12.4 ml/kg/min), and echocardiographic parameters in patients with systolic heart failure and an implanted ICD.

Q: What question did this study set out to answer?

The study aimed to assess the effects of individualized training on physical capacity and cardiac parameters in patients with systolic heart failure and implanted ICD.

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Key result

A 6-month individual training program significantly improved exercise tolerance, including peak oxygen uptake (15.9 vs 12.4 ml/kg/min), and echocardiographic parameters in patients with systolic heart failure and an implanted ICD.

Why the study?

Does a 6-month individual training program improve physical capacity and echocardiographic parameters in patients with systolic heart failure (NYHA III) and an implantable cardioverter-defibrillator?

Population

n=84 patients with systolic heart failure of ischemic or non-ischemic etiology, NYHA class III, and an…

Comparison

Hospital rehabilitation program followed by an… vs Standard SHF care consisting of a training…

Design

RCT, randomly assigned to one of two groups

Follow-up

18 months

Authors

ESEdyta Smolis−BąkInstitute of Cardiology HRHanna RymuzaInstitute of Cardiology BKBarbara KazimierskaInstitute of Cardiology

Discussion

Member takes

Implication

Supports supervised exercise in NYHA III SHF with ICD; extends cardiac rehabilitation evidence to device recipients.

Key Points

The study aimed to assess the effects of individualized training on physical capacity and cardiac parameters in patients with systolic heart failure and implanted ICD.
84 patients with systolic heart failure were randomly assigned to training (ICD-Ex) or control (ICD-control) groups.
Patients in the ICD-Ex group underwent a hospital rehabilitation program followed by 6 months of individualized outpatient training.
Cardiopulmonary exercise tests and echocardiographic assessments were conducted at baseline, 6 months, and 18 months.
ICD-Ex group showed significant improvements in VO2 peak (13.0 vs. 15.9 ml/kg/min, p < 0.0017) and other CPX parameters at 18 months.
Left ventricular ejection fraction improved significantly in both groups, but ICD-Ex had better outcomes at 6 and 18 months compared to baseline.
The distance in the 6-minute walk test was significantly longer for the ICD-Ex group compared to the control group (491 vs. 423 m, p < 0.04).

Study Design

Type

RCT (n=84)

Blinding

Open-label

Randomization

Randomly assigned

Multicenter

Structured PICO

Does a 6-month individual training program improve physical capacity and echocardiographic parameters in patients with systolic heart failure (NYHA III) and an implantable cardioverter-defibrillator?

Population

84 outpatients with systolic heart failure (NYHA III, LVEF ≤ 35%) and an implanted cardioverter-defibrillator, followed for 18 months.

Intervention

Hospital rehabilitation program followed by an individual 6-month outpatient training program consisting of interval workouts with a cycloergometer (average 30 min, 55-64 rpm) and conditioning exercises with elements of resistance exercises (5-10 min, 10-12 reps) 3 times a week.

Comparator

Standard SHF care (ICD-control) consisting of a training program during hospitalization, but no controlled activities after discharge; received guidelines on a healthy lifestyle.

Outcome

Level of physical capacity (cardiopulmonary exercise testing parameters including VO2 peak, VCO2 peak, METs, work load) and echocardiographic parameters at 6 and 18 months.surrogate

Main Result

Absolute Event Rate: 15.9% vs 12.4%

p-value: p=<0.05

Limitations

Conducted in a single cardiology center
Relatively small sample size
Substantial number of dropouts during the study
Did not improve clinical outcomes such as hospitalizations or mortality

Cite This Study

Smolis−Bąk et al. (2016) conducted an RCT in Systolic heart failure (NYHA III) with an implantable cardioverter-defibrillator (n=84). 6-month individual rehabilitation program vs. Standard heart failure care was evaluated on VO2 peak at 18 months (ml/kg/min) (p=<0.05). A 6-month individual training program significantly improved exercise tolerance, including peak oxygen uptake (15.9 vs 12.4 ml/kg/min), and echocardiographic parameters in patients with systolic heart failure and an implanted ICD.

synapsesocial.com/papers/6a5371d5ccaddfa6a4d84151 https://doi.org/10.5114/aoms.2016.61938

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Improvement of exercise tolerance in cardiopulmonary testing with sustained safety after regular training in outpatients with systolic heart failure (NYHA III) and an implantable cardioverter-defibrillator. Prospective 18-month randomized study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Improvement of exercise tolerance in cardiopulmonary testing with sustained safety after regular training in outpatients with systolic heart failure (NYHA III) and an implantable cardioverter-defibrillator. Prospective 18-month randomized study

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Also Consider