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Trial registered on ANZCTR


Registration number
ACTRN12616000429459p
Ethics application status
Not yet submitted
Date submitted
20/02/2016
Date registered
4/04/2016
Date last updated
4/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Respiratory muscle training to improve exercise capacity and quality of life in people with pulmonary arterial hypertension
Scientific title
A mechanistic study of respiratory muscle training to improve exercise capacity and quality of life in people with pulmonary arterial hypertension
Secondary ID [1] 288586 0
None
Universal Trial Number (UTN)
None
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Hypertension 297723 0
Condition category
Condition code
Cardiovascular 297909 297909 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised controlled study of respiratory muscle training for adults with pulmonary artery hypertension. The control group (Arm 1) will continue with usual/standard care. The training group (Arm 2) will undergo an 10 week respiratory muscle training program that includes 2 supervised sessions per week.

The respiratory muscle training group will be asked to attend hospital twice a week to undertake approximately 20 minutes of supervised training for 10 weeks. These sessions will be supervised by an Exercise Physiologist with expertise in respiratory muscle training. Training involves the participant breathing through a handheld device which provides resistance to their inhalation breaths. On one other day of the week participants will be asked to do 20 minutes of respiratory muscle training at home. Any costs incurred for travel to hospital will be reimbursed. Individuals in the control group will NOT participate in the Respiratory muscle training program.

Respiratory muscle training is performed using a threshold loading inspiratory muscle trainer (Threshold IMT; Respironics, Cedar Grove, NJ, USA). The participant will be seated and can lean forward and fix their arms on a chair or table if desired. The target inspiratory training load will initially be 30% of the maximum inspiratory pressure measured during assessment. The training will consist of:

1-minute warm-up at 50% of the target inspiratory training load
2 minutes of inspiratory muscle training at the target load followed by 1 minute rest

This 2-minute training plus 1-minute rest will be repeated seven times giving a total of 14 minutes of inspiratory muscle training and a total session time of 21 minutes. .

The training load will be increased based on maintaining the participant’s symptoms of perceived exertion at 3-4 (‘moderate’ to ‘somewhat heavy’) on the modified Borg 0-10 category-ratio rate of perceived exertion (RPE) scale. Participants will be asked to keep a diary to record their home training sessions to monitor adherence.

Intervention code [1] 293981 0
Rehabilitation
Intervention code [2] 294074 0
Treatment: Other
Comparator / control treatment
Standard care that includes continuing medical therapy and usual levels of physical activity.
Control group
Active

Outcomes
Primary outcome [1] 297429 0
Peak oxygen uptake measured at cardiopulmonary exercise testing using a ramp protocol and open circuit spirometer.
Timepoint [1] 297429 0
10 weeks
Secondary outcome [1] 321025 0
6 minute walk distance.
Timepoint [1] 321025 0
10 weeks
Secondary outcome [2] 321343 0
Quality of life (Sf-36)
Timepoint [2] 321343 0
10 weeks

Eligibility
Key inclusion criteria
Inclusion criteria are age greater than or equal to 18 years with either idiopathic or connective tissue disease related pulmonary arterial hypertension (mean arterial pressure of age greater than 25mmHg at rest assessed by right heart catherization) with NYHA Class II/III.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are major intellectual instability, non-English speaking background, clinically unstable patients, lung volumes < 80% predicted, pregnancy and change in medication within 3 months of study commencement.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet 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

Funding & Sponsors
Funding source category [1] 292935 0
University
Name [1] 292935 0
University of Sydney
Address [1] 292935 0
University of Sydney, NSW 2006
Country [1] 292935 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 291697 0
Hospital
Name [1] 291697 0
Royal Prince Alfred Hospital
Address [1] 291697 0
Missenden Rd Camperdown NSW 2050
Country [1] 291697 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 294440 0
Royal Prince Alfred Hospital SLHD Ethics Committee
Ethics committee address [1] 294440 0
Royal Prince Alfred Hospital
Missenden Rd,
Camperdown NSW Australia 2050
Ethics committee country [1] 294440 0
Australia
Date submitted for ethics approval [1] 294440 0
21/04/2016
Approval date [1] 294440 0
Ethics approval number [1] 294440 0

Summary
Brief summary
We hypothesise that strengthening the respiratory muscles will improve exercise capacity and improve quality of life in people with pulmonary hypertension. This work plans to generate important information to help clinical specialists treat people suffering from pulmonary arterial hypertension. Currently, the best drug therapies available improve the distance a person can walk in 6 minutes by a mere 50m. Traditional types of exercise have been shown to have similar beneficial effects on exercise capacity, symptoms and quality of life but training needs to be carefully supervised because of safety issues making it impractical for many people. Respiratory muscle training places minimal stress on the cardiovascular system and thus could be safely performed in the home setting and may have important benefits in the setting of PAH.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63710 0
Dr Rachael Cordina
Address 63710 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Country 63710 0
Australia
Phone 63710 0
+61 2 95156111
Fax 63710 0
Email 63710 0
rachael.cordina@sswahs.nsw.gov.au
Contact person for public queries
Name 63711 0
Dr Rachael Cordina
Address 63711 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Country 63711 0
Australia
Phone 63711 0
+61 2 95156111
Fax 63711 0
Email 63711 0
rachael.cordina@sswahs.nsw.gov.au
Contact person for scientific queries
Name 63712 0
Dr Rachael Cordina
Address 63712 0
Department of Cardiology,
Royal Prince Alfred Hospital
Missenden Rd, Camperdown NSW 2050
Country 63712 0
Australia
Phone 63712 0
+61 2 95156111
Fax 63712 0
Email 63712 0
rachcordina.cordina@sswahs.nsw.gov.au

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