None listed
Conditions
Brief summary
The aim of the study is to provide guidance to clinicians in relation to the safety and effectiveness of exercise training for pulmonary hypertension (PH) patients. More specifically, the study will have the following aims: 1) To examine the short-term outcomes and safety of exercise training in patients with PH 2) To examine the impact of exercise training on cardiac function at rest and during exercise using cardiac magnetic resonance imaging 3) To examine the long-term outcomes including adverse events and clinical worsening following exercise training. The study hypotheses are: 1) Exercise training will have beneficial effects in terms of improved exercise capacity, quality of life and a reduction in disease severity, with no increase in adverse events 2) Exercise training will result in improved cardiac function as measured using cardiac MRI, both at rest and during submaximal exercise 3) Participants who undertake exercise training will have a longer period without clinical worsening, using a minimum 2-year follow-up period
Interventions
Exercise training: Twice weekly, group-based, 8-week exercise-based rehabilitation program run in an hospital outpatient setting.
Exercise training will be supervised by a physiotherapist or an accredited exercise physiologist. Each subject will commence the first session by undertaking a minimum of 10 min of cycling and 10 min of treadmill training. Interval training (60s exercise, 120s rest) will be used if participants are unable to complete 10 min of continuous exercise. The duration of cycl
Exercise training: Twice weekly, group-based, 8-week exercise-based rehabilitation program run in an hospital outpatient setting. Exercise training will be supervised by a physiotherapist or an accredited exercise physiologist. Each subject will commence the first session by undertaking a minimum of 10 min of cycling and 10 min of treadmill training. Interval training (60s exercise, 120s rest) will be used if participants are unable to complete 10 min of continuous exercise. The duration of cycling and treadmill exercise will be up-titrated with the aim that each subject is completing 20 min each of cycling and treadmill exercise by the end of week 4. The exercise group will commence training at 70% of six-minute walk test (6MWT) speed which will be titrated up to 90% of 6MWT as tolerated over the first 4 weeks of training, at which point training heart rate (HR) and rate of perceived exertion (RPE) will be determined. Training intensity will be maintained at this HR and RPE for the remainder of the training period. Cycle intensity will be calculated using the 6MWT distance from standard equations. Participants will be monitored so that HR during training will be less than 90% of peak 6MWT HR, SaO2> 85% and RPE <13. If required, supplemental oxygen will be provided during exercise sessions to maintain SpO2> 85%.The exercise training session should take approx. 45-60 min to complete. The number of exercise sessions attended by each participant over the 8-wk intervention will be recorded. Following the exercise training program, participants will be prescribed a standard home-exercise training program. The home program will consist of the participant being asked to walk 3-5 times per week for 20-30 minutes. Participants will be asked to walk at an RPE similar to that which they achieved during the exercise training program. Compliance with the home exercise program will be monitored at subsequent follow-up clinical visits over a 2 year period.
Sponsors
Professor Norm Morris
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) Confirmed diagnosis of pulmonary hypertension based on right heart catheterization procedure. Mean pulmonary artery pressure > 25 mmHg and pulmonary capillary wedge pressure of < 15 mmHg 2) On stable pulmonary hypertension medical therapies and exacerbation-free in the previous 3 months 3) Participants will be New York Heart Association (NYHA) Class II-III
Exclusion criteria
1) Individuals < 18 years of age 2) Pregnant Females 3) Patients who have changed pulmonary hypertension medication in the previous 3 months 4) Patients with significant co-morbidities including left sided heart failure 5) Patients with recent (within one month) history of syncope or light-headedness during exercise 6) Patients with significant musculoskeletal or neurological conditions likely to affect their exercise performance 7) Individuals who would be excluded from performing an exercise as per American College of Sports Medicine Guidelines
Outcome results
None listed