None listed
Conditions
Brief summary
This study aims to evaluating the effects of aerobic and resistance exercise in “stiff” heart failure. We will utilize various methods to assess the efficacy of the exercise regime in order to validate it. We postulate this regime will have a favourable effect on the structure and the function of the heart whilst providing symptomatic benefit to the patient.
Interventions
The CPET assessment would be undertaken for each patient to individualise the training program. This will be performed by a CPET qualified practitioner (exercise physiologist/cardiologist/respiratory physician). Aerobic exercise responses will be monitored using heart rate, blood pressure, and the BORG Rating of Perceived Exertion (RPE) scale, based on a scale from 6 to 20 (6=rest; 20=maximal intensity).
Performing the CPET :Maximum predicted workload will be calculated using Jones equation. W
The CPET assessment would be undertaken for each patient to individualise the training program. This will be performed by a CPET qualified practitioner (exercise physiologist/cardiologist/respiratory physician). Aerobic exercise responses will be monitored using heart rate, blood pressure, and the BORG Rating of Perceived Exertion (RPE) scale, based on a scale from 6 to 20 (6=rest; 20=maximal intensity). Performing the CPET :Maximum predicted workload will be calculated using Jones equation. We will use an incremental ramp protocol. First, the maximal steady state (MSS) zone will be determined from the ventilatory and lactate threshold (Ventilatory Threshold 1 and Ventilatory threshold 2) during the CPET. The MSS zone will be the heart rate achieved between ventilatory threshold 1 and 2 . The peak heart rates will also be determined by the CPET study. If the ventilatory threshold cannot be obtained due to confounders we will use the Borge rating of perceived exertion. Based on the MSS heart rate and peak heart rate (HRpeak), 4 training zones will be established for each participant: (1) MSS (2) base pace (BP) (1-20 heart beats below MSS and 75- 85% of maximal heart rate, 30 minute sessions). (3) interval (HIIT) (>95% HRpeak). (4).recovery (<base pace). 1 CPET will be done at the start of the trial and 1 CPET will be done at the end of the exercise intervention The CPET study duration is 30 minutes ================================================================================================================================================================ Detailed description of the exercise intervention. Participants will visit the Gym 3 time a week for 24 weeks. Supervision will be 1:1 during initial visits and depending on the patient familiarity and training supervision may become 2 -4:1 . Supervision and guidance will be provided by an exercise professional (exercise physiologist/ Physiotherapist) or doctor. Session attendance checklist with total time exercised will be documented. ================================================================================================================================================================= The early training phase (up to 4 weeks) will establish an endurance base. Participants will be acclimated to the training with three BP sessions a week. Each BP session will be 30 minutes in duration. BP session will performed on a stationary cycle of treadmill. One HIIT session will replace one BP session from week 5. HIIT will initially consist of one minute sessions. Each training day will consist of four sessions. Therefore (day 1 will have 1minute X4 sessions),Individual session durations will be increased from 1 minute to 4 minutes over the course of 12 weeks, the number of sessions will remain the same each day (4 sessions). Between HIIT sessions participant will have a moderate intensity active recovery time of 1.5 minutes initially during the 1 minutes HIIT sessions and then 3 minute active recovery during the 4 minute HIIT sessions. The total exercise time on day 1 will be (1 minutes HIITx 4 sessions= 4 minutes) and ( 1.5 minutes active recovery X 3= 4.5 minutes) = 8.5 minutes Warm up and warm down time on day 1 = 10 minutes each Total time on day 1= 28.5 minutes ( 30 minutes) The duration of each HIIT session within a given day will increase progressively depending on patient preference and suitability until 4minutesX 4 sessions per day is achieved. We will introduce a second HIIT session to replace a BP session from week 17. This increase provides a total of two HIIT sessions a week and one BP session a week from week 17 to week 24. HIIT will be performed on a stationary cycle or a treadmill =============================================================================================================================================================== From week 9 progressive resistance training(PRT) sessions will be included with BP sessions. PRT will gradually increase to 2 sessions a week from week 13 and then continued until week 24. PRT session will also be done with HIIT session from week 13. PRT is defined as training with 80% of the maximal weight than can be lifted in good form (the one repetition maximum [1RM]). Strength will be retested every 7th session to establish a new 1RM. Dynamic contractions of the large upper and lower body muscle groups will be performed on pneumatic-resistance training equipment. Subjects will perform 2 sets of six repetitions. Each repetition will last 6-9 seconds with a 2-3 second rest between repetitions and a 60-90 second rest between sets. Total duration of a PRT session would be 15 minutes with warm up and warm down Dynamic contractions of the large upper and lower body muscle groups will be performed on pneumatic-resistance training equipment as a part of PRT. =============================================================================================================================================================== After week 8 of supervised training, we will educate participants to perform 2 thirty minute BP sessions a week at home. Participants will be able to monitor their own heart rates during the home BP sessions using a wearable heart rate monitor provided by the project.
Sponsors
Sydney Local health District
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria - NYHA class II-III at screening - Age greater than or equal to 18 years at screening - Signed and dated written informed consent in accordance with local legislation with ability to understand the participation information sheet - Left ventricular ejection fraction (LVEF) = 50% as measured by ECHO at screening and no previous measurement of LVEF = 50% • ECHO at screening or within 3 months which shows one the following • GLS < 16% or E/e’ =15 or left ventricular wall thickness >12mm or RWT>0.42 or left atrial volume index >29ml/m2 or left ventricular mass index >115g/m2 for men and >95g/m2 for women - One of the signs or symptoms of heart failure as per the Framingham heart failure definition listed below. Signs Elevated jaguar venous pressure third heart sound Summation gallop with third and fourth heart sound Cardiomegaly with laterally displaced apex impulse Pulmonary rales Dullness to percussion of the lungs Symptoms Breathlessness Orthopnoea Paroxysmal nocturnal dyspnoea Reduced exercise tolerance Ankle swelling inability to exercise fatigue and tiredness swelling other parts of the body other than ankles
Exclusion criteria
Exclusion criteria 1. Non-heart failure with preserved ejection fraction (HFpEF) causes for HF symptoms (significant valvular (moderate or above) or significant coronary disease, uncontrolled hypertension or arrhythmias, primary cardiomyopathies) 2. Significant pulmonary disease such as chronic obstructive pulmonary disease -global initiate for obstructive lung disease class III-IV (COPD-GOLD) or any other severe lung disease 3. Inability to exercise or conditions that may interfere with exercise intervention 4. Pulmonary vascular diseases (pulmonary arterial hypertension, pulmonary veno-occlusive disease, chronic thromboembolic pulmonary hypertension, chronic thromboembolic disease) and those with pre-capillary pulmonary hypertension due to lung disease and/or hypoxia or with pulmonary hypertension due to unclear/multifactorial mechanisms 5. Active internal bleeding or history of haemorrhagic diathesis 6. Unstable angina, myocardial infarction in the past 4 weeks 7. Pregnant or planning to become pregnant in the year following study entry 8. Major heart event or heart procedure within the 6 weeks prior to study entry 9. Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training 10. Uncorrected anaemia below <70g/L 11. Active malignancy with life expectancy of less than 1 year.
Outcome results
None listed