Please note that the ANZCTR website will be unavailable from 9am until 9.30am (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension
Scientific title
Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pulmonary arterial hypertension 236994 0
Condition category
Condition code
Cardiovascular 237331 237331 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
exercise training with a focus on endurance training; 12 week program of three times per week attendance (1hr per session)
Intervention code [1] 236754 0
Comparator / control treatment
Usual medical care as determined by the patients pulmonary arterial hypertension (PAH) physician
Control group

Primary outcome [1] 238152 0
exercise capacity as measured by cardiopulmonary exercise tests - incremental and contant-workload [peak oxygen uptake (VO2), anaerobi threshold (AT), endurance time]
Timepoint [1] 238152 0
Baseline, 12 and 24 weeks
Primary outcome [2] 238153 0
Health related quality of life using the SF36 and Cambridge Pulmonary Hypertension Outcome Review
Timepoint [2] 238153 0
Baseline, 12 and 24 weeks
Primary outcome [3] 238154 0
Reported number of adverse events. Adverse
events may include: (i) incident requiring a medical emergency team call (according to Royal Perth Hospital (RPH) criteria); (ii)
exercise-related incident requiring presentation to Emergency Department or General Practitioner; (iii) hospital
admission due to PAH or worsening right heart failure;
Timepoint [3] 238154 0
Throughout study period, if an adverse event occurs
Secondary outcome [1] 242388 0
Ventilatory variables at isotime during the constant workload cycle ergometry test ?ventilatory equivalent for
carbon dioxide (VE/VCO2) and end tidal carbon dioxide (PetCO2) to describe ventilatory efficiency
Timepoint [1] 242388 0
Baseline, 12 and 24 weeks
Secondary outcome [2] 242389 0
Walking distance measured via the six minute walk test (6MWT)
Timepoint [2] 242389 0
Baseline, 6, 12 and 24 weeks
Secondary outcome [3] 242390 0
Changes in World Health Organisation (WHO) functional class using the WHO PAH functional classification system
Timepoint [3] 242390 0
Baseline, 12 and 24 weeks
Secondary outcome [4] 242391 0
Worsening clinical status.
Worsening clinical status will be defined by the presence of two or more of the following: (i) ? 20% deterioration in 6MWD (ii) escalation of medical therapy (increased dose of medication or
commencement of intravenous epoprostenol); (iii) deterioration (?1) in WHO functional class; (iv) development of
right heart failure (as indicated by increased jugular venous pressure, new/worsening hepatomegaly, ascites or
peripheral oedema); (v) oedema that does not respond to oral diuretics; (vi) hospitalisation for PAH; (vii) listed for
transplantation; (viii) progressive worsening of dyspnoea and exercise tolerance at rest or on exertion over the past
3-5 days; (ix) deterioration in ventilatory efficiency (VE/VCO2) refecting worsening gas exchange.
Timepoint [4] 242391 0
Throughout study period should a subject's condition worsen according to the above criteria
Secondary outcome [5] 242392 0
Resting echocardiogram ? to asses right ventricular size and function, right atrial size, pulmonary arterial systolic pressure
(PASP) and where PASP cannot be determined, pulmonary acceleration time.
Timepoint [5] 242392 0
Baseline, 12 and 24 weeks

Key inclusion criteria
Idiopathic or familial PAH
WHO functional class II and III
Medically stable
On PAH-specific medication for at least 3 months prior to enrolment
Able/willing to attend an exercise class and continue with a home exercise program
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
PAH associated with connective tissue diseases
Require oxygen therapy
Significant musculoskeletal, neurological or cognitive impairments that limit the ability to perform in a class environment
Involvement in a supervised exercise program within the last 12 months

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be recruited by medical staff from the Pulmonary Hypertension Unit at Royal Perth Hospital. Subjects will be randomly allocated to the exercise or control group following baseline assessment using a randomisation table. Allocation will be performed by the physiotherapists supervising the exercise group, who are not involved in the assessment of the subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To achieve balanced groups. subjects will be stratified based on their 6MWD being > or = 70% of their predicted 6MWD. A randomisation table will be generated, one for each group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237146 0
Self funded/Unfunded
Name [1] 237146 0
Address [1] 237146 0
Country [1] 237146 0
Primary sponsor type
Curtin University of Technology
Kent Street Bentley
Western Australia 6102
Secondary sponsor category [1] 4638 0
Name [1] 4638 0
Royal Perth Hospital
Address [1] 4638 0
Wellington Street
Western Australia 6000
Country [1] 4638 0

Ethics approval
Ethics application status
Ethics committee name [1] 239240 0
Royal Perth Hospital
Ethics committee address [1] 239240 0
Wellington Street
Western Australia 6000
Ethics committee country [1] 239240 0
Date submitted for ethics approval [1] 239240 0
Approval date [1] 239240 0
Ethics approval number [1] 239240 0
EC 2009/012

Brief summary
This randomised controlled trial will determine whether a 12 week, outpatient, supervised exercise training program, followed by a home-based maintenance exercise program, is safe and improves exercise capacity and quality of life (QoL) in patients with PAH.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 29740 0
Address 29740 0
Country 29740 0
Phone 29740 0
Fax 29740 0
Email 29740 0
Contact person for public queries
Name 12987 0
Louise Ganderton
Address 12987 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 12987 0
Phone 12987 0
+61 8 9224 1783
Fax 12987 0
Email 12987 0
Contact person for scientific queries
Name 3915 0
Louise Ganderton
Address 3915 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth Western Australia 6845
Country 3915 0
Phone 3915 0
+61 8 9224 1783
Fax 3915 0
Email 3915 0

No information has been provided regarding IPD availability
Summary results
No Results