Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000502235
Ethics application status
Approved
Date submitted
14/06/2009
Date registered
23/06/2009
Date last updated
23/02/2010
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

Intervention/exposure
Study type
Interventional
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
Rehabilitation
Comparator / control treatment
Usual medical care as determined by the patients pulmonary arterial hypertension (PAH) physician
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239240 0
Royal Perth Hospital
Ethics committee address [1] 239240 0
Ethics committee country [1] 239240 0
Australia
Date submitted for ethics approval [1] 239240 0
03/02/2009
Approval date [1] 239240 0
17/03/2009
Ethics approval number [1] 239240 0
EC 2009/012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
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
Australia
Phone 12987 0
+61 8 9224 1783
Fax 12987 0
Email 12987 0
[email protected]
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
Australia
Phone 3915 0
+61 8 9224 1783
Fax 3915 0
Email 3915 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseShort term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: Protocol for a randomised controlled trial.2011https://dx.doi.org/10.1186/1471-2466-11-25
N.B. These documents automatically identified may not have been verified by the study sponsor.