To explore the feasibility, safety, health and psychological benefits of a 12-week high intensity exercise programme in a young group of individuals with hypertrophic cardiomyopathy (HCM). This will pave the way for a large-scale randomised study of safety of exercise in HCM, the results of which will strengthen the evidence base for exercise recommendations.
A greater understanding of the pathogenic mechanisms underpinning HCM has translated to improved medical care and better survival of affected individuals. Historically these patients were considered to be at high risk of sudden cardiac death during exercise, therefore exercise recommendations were highly conservative and promoted a sedentary life style. There is emerging evidence which suggests that exercise in HCM has a favourable effect on cardiovascular remodelling and moderate exercise programmes have not raised any safety concerns. Furthermore, individuals with HCM have a similar burden of atherosclerotic risk factors as the general population in whom exercise has been associated with a reduction in myocardial infarction, stroke and heart failure, especially among those with a high-risk burden. Small studies have revealed that athletes who choose to continue with regular competition do not demonstrate adverse outcomes when compared to those who discontinue sport, and active individuals implanted with an implantable cardioverter defibrillator (ICD) do not have an increased risk of appropriate shocks or other adverse events. The recently published exercise recommendations from the European Society of Cardiology account for more contemporary evidence and adopt a more liberal stance regarding competitive and high intensity sport in individuals with low-risk HCM. However, further work is required into exercise prescription in younger non competitive individuals participating in higher intensity exercise. Moreover low/moderate intensity exercise may be appropriate for older HCM patients, it is unlikely to attract younger, often asymptomatic patients, who wish to engage in higher intensity regimes.Therefore this study aims to assess the feasibility, safety and outcomes of an individually tailored, high intensity exercise programme in young patients with HCM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
80
12 weeks high intensity exercise programme
Guys and St Thomas's Hospital
London, United Kingdom
Kings College Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
Safety composite outcome
This will be reported as the number of people who reach the composite safety outcome (the occurrence of at least one) of the following measured variables 1)cardiovascular death; 2)cardiac arrest; 3) appropriate or inappropriate ICD therapy; 4)exercise induced syncope; 5)sustained ventricular tachycardia; 6) non-sustained ventricular tachycardia; or 7)sustained atrial arrhythmias \>30seconds post testing and at 6 months.
Time frame: 6 months
Feasibility (qualitative outcome)
Feasibility will be reported qualitatively using an open ended questionnaire through analysis of the following a) response to invitation to participate and reasons for refusal; b) adherence to the cardiac rehabilitation programme; c) practical issues related to the programme including staffing and resource assessment; d) acceptability of the intervention and educational materials provided to patients and families
Time frame: 12 weeks
Impact on exercise capacity; time to anaerobic threshold (tAT) (seconds)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on exercise capacity; total exercise time (tMax) (seconds)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on exercise capacity; VO2(ml/kg/min) at AT (VO2/kgAT) (ml/kg/min)
The anaerobic threshold (AT) was calculated initially using the V slope method (visual estimation from the VCO2 and VO2 graphs at the point where the slope of the VCO2 curve exceeded the slope of the VO2 curve). This was checked manually using the raw data and 10 second averaging. All data was additionally averaged over 10 seconds at this point and the averaged VO2 ml/kg/min value used as the VO2 at the AT. This variable will be assessed individually and compared to baseline values post testing and at 6 months.
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Time frame: 6 months
Impact on exercise capacity; peak VO2(ml/kg/min) (VO2/kgMax) (ml/kg/min)
CPET analysis was performed using COSMED Quark CPET metabolic cart (Rome, Italy). This automatically calculated peak VO2 ml/min and converted it to ml/kg/min using the patient's weight which had been inputted into the program prior to commencing the CPET. This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on exercise capacity; VE/VCO2 slope (ratio)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on exercise capacity; physical activity levels (hours/week)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on cardiovascular risk factors; blood pressure (BP) (mmHg)
This variable will be assessed individually and compared to baseline values post testing and at 6 months.
Time frame: 6 months
Impact on cardiovascular risk factors; body mass index (BMI) (kg/m2)
This variable will be assessed individually and compared to baseline post testing and at 6 months.
Time frame: 6 months
Impact on cardiovascular risk factors; lipid profile (mmol/l)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on cardiovascular risk factors; HbA1c (mmol/mol)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on QoL and psychological parameters; Short form 36 (SF36) scores
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The SF-36 is comprised of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is converted into a 0-100 scale, with a lower score denoting greater disability.
Time frame: 6 months
Impact on QoL and psychological parameters; Hospital anxiety and depression scale (HADS) scores
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The HADS questionnaire consists of seven items each for depression and anxiety. Each item is scored from zero to three, with three the highest anxiety or depression level. Either an anxiety or depression score of \>8 points (total 21) denotes considerable symptoms of anxiety or depression.
Time frame: 6 months
Impact on QoL and psychological parameters; WHO disability assessment scale II (WHODAS II) scores
This variable will be assessed individually and compared to baseline values post testing and at 6 months. The WHODAS II score can be calculated using simple scoring where the following scores are assigned to each item - none (1), mild (2) moderate (3), severe (4) and extreme (5). The scores are then summed, with a higher score denoting greater disability.
Time frame: 6 months
Impact on disease phenotype-cardiac biomarkers; troponin (ng/l)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-cardiac biomarkers; BNP (ng/l)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LA volume (ml)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVEDD (mm)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; LVWT (mm)
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-echocardiographic outcomes; diastolic parameters (E/E', E/A))
This variable will be assessed individually and compared to baseline values post testing.
Time frame: 12 weeks
Impact on disease phenotype-ventricular ectopic burden;
The absolute number of ventricular ectopics will be assessed and compared to baseline values post testing post testing and at 6 months.
Time frame: 6 months