Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000077268
Ethics application status
Approved
Date submitted
3/12/2008
Date registered
30/01/2009
Date last updated
30/01/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise training for pulmonary arterial hypertension
Scientific title
The effect of exercise training on safety, exercise capacity and quality of life in people with pulmonary arterial hypertension - a pilot study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary arterial hypertension 4056 0
Condition category
Condition code
Cardiovascular 4265 4265 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised exercise training conducted as an outpatient at the hospital. Participants will attend 90 minute sessions twice weekly for eight weeks and will undertake an individualised program under the supervision of a physiotherapist. Training will include walking, cycling and light weights for the arms and legs.
Intervention code [1] 3780 0
Rehabilitation
Comparator / control treatment
N/A - this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5151 0
adverse events: Failure to complete the prescribed exercise session or failure to achieve the set exercise intensity; Oxygen desaturation to less than 85% or heart rate > 140 beats per minute; Failure to progress the exercise prescription in subsequent sessions according to the protocol; Symptoms of dizziness, chest pain, palpitations or episodes of syncope / pre-syncope
Timepoint [1] 5151 0
Assessed immediately after each exercise session during the 8 week study period
Secondary outcome [1] 8668 0
6-minute walk test
Timepoint [1] 8668 0
Baseline and immediately following the 8 weeks of training
Secondary outcome [2] 8669 0
quality of life - measured with the Medical Outcomes Study Short Form 36 (SF-36)
Timepoint [2] 8669 0
Baseline and immediately following the 8 weeks of training
Secondary outcome [3] 8670 0
quadriceps strength - measured with an isokinetic dynamometer
Timepoint [3] 8670 0
Baseline and immediately following the 8 weeks of training

Eligibility
Key inclusion criteria
Patients will be eligible for inclusion if they are are aged over 18 years and in New York Heart Association (NYHA) functional class II – III. Eligible patients will also be clinically stable and compensated on optimal medical therapy. Clinical stability will be defined as stable symptoms and no evidence of heart failure, a stable NYHA score and no changes in medical therapy over the last three months (16). Patients wth Idiopathic Pulmonary Arterial Hypertension (IPAH) as well as those with Pulmonary arterial hypertension (PAH) related to connective tissue disease, congenital heart disease, sarcoidosis or the human immunodeficiency virus (HIV) will be eligible to participate. All patients will need to have had PAH confirmed on prior right heart catheterisation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
recent syncope (within the last three months) or comorbidities which would preclude participation in an exercise program

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4239 0
Self funded/Unfunded
Name [1] 4239 0
Country [1] 4239 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Commercial Rd Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 3812 0
None
Name [1] 3812 0
Address [1] 3812 0
Country [1] 3812 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Pulmonary arterial hypertension (PAH) is a debilitating and life-threatening vascular disease affecting the lungs.
Exercise training has traditionally had little role in the management of patients with PAH due to fears that it may cause disease progression and increase the risk of sudden death. However, this assumption may no longer be valid in patients who are stabilised on new medical therapies. We hypothesise that a supervised exercise training program conducted in the outpatient setting is safe and feasible, and improves exercise capacity, strength and quality of life in people with PAH. People with PAH will undergo 8 weeks of supervised exercise training in the outpatient setting. We will record any adverse events that ocfur during training. Before and after the training we will measure exercise capacity, strength and quality of life. the results of this study will indicate whether exercise training is safe for people with PAH and whether it has potential as a new treatment to improve exericse capacity and wellbeing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29190 0
Address 29190 0
Country 29190 0
Phone 29190 0
Fax 29190 0
Email 29190 0
Contact person for public queries
Name 12347 0
Anne Holland
Address 12347 0
Physiotherapy Dept, Alfred Hospital, Commercial Rd Melbourne Victoria 3004
Country 12347 0
Australia
Phone 12347 0
+61 3 90763450
Fax 12347 0
Email 12347 0
[email protected]
Contact person for scientific queries
Name 3275 0
Anne Holland
Address 3275 0
Physiotherapy Dept, Alfred Hospital, Commercial Rd Melbourne Victoria 3004
Country 3275 0
Australia
Phone 3275 0
+61 3 90763450
Fax 3275 0
Email 3275 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
No additional documents have been identified.