None listed
Conditions
Brief summary
Pulmonary hypertension (PH), characterised by elevated pressure within the blood vessels of the lungs, is associated with progressive breathlessness, functional limitation and increased risk of death. PH has unacceptably low survival with 1, 3 and 5 year median survival rates only 85%, 66% and 53%. Exercise has recently been found to be beneficial in PH, with benefits similar to pharmacotherapy (Morris 2016). Traditionally patients with PH have not been included in exercise programs due to safety concerns. However, a recent Cochrane review of 6 RCTs including 206 patients, reported only a single adverse event (in which training was stopped for a single session due to lightheadedness). This pilot study proposes to assess 1. the feasibility of Innocor testing in conjunction with exercise testing to assess the cardiac output of patients with stable PH. 2. the safety of four 6-minute bouts of exercise a in a cohort of stable PH patients. This will be achieved through realtime measurement of cardiac response to standard Pulmonary Rehabilitation exercises in a cohort of patients with known stable PH. This pilot project is the first of its kind to assess using the Innocor, a breathing test from which cardiac output can be calculated.
Interventions
This is a one arm trial.
The intervention involves a single session of exercise testing performed following medical review in a hospital clinic. Following a routine clinical appointment with an individual's treating respiratory physician, participants will return to the Respiratory Laboratory and, under the supervision of a senior exercise physiologist (minimum 7 years experience) and respiratory scientist, will perform a 6 minute walk test (which is part of standard care) and 3 additional exerc
This is a one arm trial. The intervention involves a single session of exercise testing performed following medical review in a hospital clinic. Following a routine clinical appointment with an individual's treating respiratory physician, participants will return to the Respiratory Laboratory and, under the supervision of a senior exercise physiologist (minimum 7 years experience) and respiratory scientist, will perform a 6 minute walk test (which is part of standard care) and 3 additional exercises (which reflect the standard exercises prescribed during community-based stage 1 pulmonary rehabilitation) with pre- and post-exercise testing using a novel breathing test – Innocor. [The Innocor measures a surrogate for cardiac output utilising an inert gas rebreathing technique, and a relatively simple breathing manoeuvre with inhalation of a gas containing a mixture of soluble (nitrous oxide; N20) and insoluble (sulphur hexafluoride; SF6) gas. CO is proportional to the rate of decline of the soluble compound (N20) as it is cleared by the pulmonary circulation. Innocor haemodynamic measurements have been validated against gold standard right heart catheterisation (RHC) and cardiac MRI, and have been shown to detect response to treatment in pulmonary hypertension.] The exercises selected are prescribed commonly within the local Community Pulmonary Rehabilitation program and are translatable to what would be performed in the outpatient setting. The exercises are: 1. Upper limb resistance exercises for 6 minutes (including rests between sets) involving ten repetitions of each of four upper limb exercises: the downward diagonal cross arm lift, single alternating arm military press (shoulder press), forward arm lift and double arm row. 2. Stationary exercise bike for 6 minutes, at 60 revolutions per minute, with documentation of work rate achieved (Watts) 3. Sit to stand and step up for 6 minutes (including rests between sets). The absolute intensity of the exercise will be individualised for each participant, through the participant's self-reported rating of perceived exertion and the clinical judgement of the exercise physiologist. The relative intensity of the exercise will be standardised across all participants (moderate intensity exercise). The overall session will be 30-45 minutes in duration (depending on the duration of rest required between exercise bouts) and will be completed under the direct supervision of the researchers.
Sponsors
Department of Respiratory and Sleep Medicine, Princess Alexander Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
*18 years and older *Diagnosis of pulmonary hypertension *Stable disease as defined by no changes to pulmonary vasodilator therapy in the previous 3 months *New York Heart Association / WHO functional class I, II or III symptoms
Exclusion criteria
*Patients not able to give informed consent *Musculoskeletal or neurological disorders that prevent exercise *Patients with absolute contraindications to respiratory function testing
Outcome results
None listed