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Trial registered on ANZCTR


Registration number
ACTRN12615001041549
Ethics application status
Approved
Date submitted
16/09/2015
Date registered
7/10/2015
Date last updated
14/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of an outpatient exercise training programme on haemodynamics and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension.
Scientific title
The effect of an outpatient exercise training programme on haemodynamics and cardiac magnetic resonance parameters of right ventricular function in patients with pulmonary arterial hypertension.
Secondary ID [1] 287490 0
Nil
Universal Trial Number (UTN)
U1111-1174-5625
Trial acronym
ExPAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary arterial hypertension 296234 0
Condition category
Condition code
Cardiovascular 296505 296505 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Outpatient rehabilitation exercise training program.
a) This involves participants attending a physiotherapy department for an exercise training programme.
b) Sessions are twice weekly for 12 weeks (i.e. total of 24 sessions).
c) Each session runs for one hour.
d) Sessions are run by physiotherapist.
e) Exercises involve: aerobic training (treadmill or cycle), respiratory muscle training and light weight training
f) intensity of Borg RPE of 12-13.
g) Format is small group (maximum of 5 participants to one phyisotherapist).
h) Monitoring of adherence will be via record of attendance and exercises performed.

Participants randomised to the training group will also have 3 structured telephone education sessions with the study psychologist (of 20 minutes duration each). These sessions will include education on managing hyperventilation, anxiety during dyspnea, and skills training (progressive muscle relaxation). These will be done at approximately week3, 6 and 9.

In addition, Sydney based participants will have the option of undergoing an exercise right heart catheterisation (RHC). These participants will have exactly the same outcome measures and undergo the same randomisation process. They will have haemodynamics, measured by RHC at rest and during exercise. The only difference is that after the initial standard haemodynamic measurements, the participant is asked to pedal at a certain work rate (for example, 60 rpm). The workload is then increased by 10W every 3 minutes, as tolerated by the participant, to a maximum of 40W, as described by Provencher, S., et al., Changes in exercise haemodynamics during treatment in pulmonary arterial hypertension. Eur Respir J, 2008. 32(2): p. 393-8.
Participants for this sub-study will be voluntary (all participants to the study based in Sydney will be asked if they wish to participate in the sub-study).
Intervention code [1] 292873 0
Rehabilitation
Comparator / control treatment
Home exercise program. Participants in the control group will be given a handout informing them of the benefits of regular exercise, and suggestion of walking (5 days per week for 30 minutes total per day). Suggestions on how to keep motivated (e.g. join Heart Foundation Walking group) as well as diary record provided.
Control group
Active

Outcomes
Primary outcome [1] 296132 0
Right ventricular ejection fraction on cardiac MRI.
Timepoint [1] 296132 0
3 months post start of intervention (exercise).
Secondary outcome [1] 317971 0
Haemodynamics, measured by right heart catheterisation at rest, and during exercise in the sub-study participants.
Timepoint [1] 317971 0
3 months post start of intervention.
Secondary outcome [2] 317972 0
Exercise capacity measured by 6MWT.
Timepoint [2] 317972 0
3 months post start of intervention and 6 months post start of intervention.
Secondary outcome [3] 317973 0
Quality of Life measured by CAMPHOR, DASS 21 and Lawton's Instrumental Activities of Daily Living.
Timepoint [3] 317973 0
3 and 6 months post start of intervention.
Secondary outcome [4] 317974 0
Muscle strength, tested by grip strength.
Timepoint [4] 317974 0
3 and 6 months post start of intervention.
Secondary outcome [5] 317975 0
Bio markers of cardiac function, measured by NT-proBNP, IL6.
Timepoint [5] 317975 0
3 and 6 months post start of intervention.

Eligibility
Key inclusion criteria
Pulmonary arterial hypertension, functional class I-III.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Change in PAH specific medication in preceding 3 months.
Enrolment in formal exercise program in preceding 3 months.
Pregnancy.
Unable to follow instructions.
Patients with significant unstable cardiac disease (e.g. unstable angina).
Patients who are unable to have MRI (impaired renal function, permanent pacemaker etc).

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)
Participants with PAH will be recruited, screened and once consent is obtained, will undergo baseline assessment. After baseline assessment, participants will be randomised to intervention (Exercise group) or control group (home exercise program). Participants will not be blind to their allocation, however, staff involved with outcome measures will be blinded. Allocation concealment will occur, as allocation to the study group will be done at a central administration site by computer randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised after their baseline visit, prior to the intervention. This will be done by adaptive minimisation, stratified by site and whether the participant has connective tissue disease associated Pulmonary arterial hypertension (CTD-aPAH), by a biostatistician external to the research project using a custom written program in SAS (Cary, North Carolina, USA). The participant will be randomised to either control (home exercise program) or the intervention (exercise group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcome measure will be right ventricular ejection fraction (RVEF) measured by cardiac MRI. Power calculations are based on comparison of randomised arms achieving the primary outcome of an increase in RVEF. We consider a 5% absolute excess increase in RVEF, measured by cMRI, for the intervention group compared to the control group as the desired clinically important effect. Using two-sided normal test, allowing for potential 10% drop out rate, 26 patients in each arm are required to detect a 5% excess increased RVEF associated with intervention versus control group with a power of 80%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4351 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 4352 0
Coffs Harbour Base Hospital - Coffs Harbour

Funding & Sponsors
Funding source category [1] 292064 0
Government body
Name [1] 292064 0
Mid North Coast Local Health District
Address [1] 292064 0
Coffs Harbour Health Campus,
345 Pacific Highway,
Coffs Harbour, NSW, 2450.
Country [1] 292064 0
Australia
Funding source category [2] 292065 0
Commercial sector/Industry
Name [2] 292065 0
Actelion
Address [2] 292065 0
ACTELION Pharmaceuticals Australia
Suite 6
13b Narabang Way
Belrose NSW 2085
Country [2] 292065 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Sydney.
Address
390 Victoria St, Darlinghurst, Sydney. NSW, 2010.
Country
Australia
Secondary sponsor category [1] 290739 0
Individual
Name [1] 290739 0
Associate Professor Eugene Kotlyar
Address [1] 290739 0
St Vincent's Hospital
390 Victoria St
Darlinghurst, NSW, 2010.
Country [1] 290739 0
Australia
Secondary sponsor category [2] 290740 0
Individual
Name [2] 290740 0
Associate Professor Steven Faux
Address [2] 290740 0
Sacred Heart Rehabilitation
170 Darlinghurst Rd,
Darlinghurst, NSW, 2010.
Country [2] 290740 0
Australia
Secondary sponsor category [3] 294320 0
Individual
Name [3] 294320 0
Karen Chia
Address [3] 294320 0
University of New South Wales Rural Clinical School,
Locked Bag 812,
Coffs Harbour, NSW 2450.
Country [3] 294320 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293548 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 293548 0
390 Victoria St,
Darlinghurst, NSW, 2010.
Ethics committee country [1] 293548 0
Australia
Date submitted for ethics approval [1] 293548 0
Approval date [1] 293548 0
18/12/2014
Ethics approval number [1] 293548 0
HREC/14/SVH/340 and HREC/14/SVH/341

Summary
Brief summary
This study looks at the effect of an outpatient exercise program on how the heart functions, using the latest technology (cardiac magnetic resonance imaging) and more established indicators of prognosis measured by right heart catheterisation. It also examines the effect of exercise on patient endurance and quality of life. The results of this study will have important widespread implications for the outpatient treatment of PAH, providing guidance regarding the optimal format of exercise in patients with PAH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60422 0
Dr Karen Chia
Address 60422 0
Mid North Coast Rehabilitation
PO Box 6307,
Coffs Harbour, NSW 2450.
Country 60422 0
Australia
Phone 60422 0
+61 414 754 976
Fax 60422 0
Email 60422 0
karen.chia@me.com
Contact person for public queries
Name 60423 0
Dr Karen Chia
Address 60423 0
Mid North Coast Rehabilitation
PO Box 6307
Coffs Harbour, NSW, 2450.
Country 60423 0
Australia
Phone 60423 0
+61 414 754 976
Fax 60423 0
Email 60423 0
karen.chia@me.com
Contact person for scientific queries
Name 60424 0
Dr Karen Chia
Address 60424 0
Mid North Coast Rehabilitation
PO Box 6307
Coffs Harbour, NSW, 2450.
Country 60424 0
Australia
Phone 60424 0
+61 414 754 976
Fax 60424 0
Email 60424 0
karen.chia@me.com

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