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Keyword: breath-stacking
Broad Health Condition: Neurological
Specific Condition: Neurodegenerative diseases
Recruitment Status: Recruiting

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Lung Volume Recruitment in Neuromuscular Disease: Can ‘breath-stacking’ improve lung function, respiratory symptoms and quality of life for people with neuromuscular disease?

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Trial Information

Trial summary

Difficulty taking deep breaths or coughing are two of the breathing complications people with a neuromuscular disease and weak breathing muscles face. Over time the lungs and rib cage become stiff, lung volumes are reduced and respiratory function is compromised. Such breathing complications are one of the main causes of discomfort, disability and ultimately death in conditions such as Duchenne muscular dystrophy and motor neurone disease.

Lung volume recruitment, also known as breath-stacking, is a simple and inexpensive therapy that may help. It involves taking a few breaths in without breathing out, so that a maximum amount of air is held in the lungs before exhaling. This pattern is repeated so that a group of ‘deep breathing exercises’ is performed. A type of resuscitation bag is used to assist each breath. It is thought that performing these breathing exercises daily might prevent chest stiffness, improve breathing capacity and cough effectiveness, however to date there is no strong evidence to support these ideas.

This research will look at the short and medium term effects of breath-stacking exercises on the breathing system, by conducting a prospective, single-blinded randomised controlled clinical trial. This means that half of the people who choose to be involved in the study will be asked to perform breath-stacking exercises each day for three months. The other half will be asked to do ‘diaphragm breathing exercises’ (a treatment we don’t believe will have a very big effect). The type of breathing exercise each individual will be asked to do is randomly allocated, i.e. there is a 50:50 chance of being in either group.

We will measure lung volumes, stiffness and cough effectiveness by breathing tests, and breathing symptoms and quality of life by questionnaires. These measurements will take place before the person begins, and then 1 month, 2 months and 3 months into the study. We will perform the 1-month and 2-month measurements in the person’s home, to reduce any potential burden or inconvenience.

If breath-stacking is beneficial and lung volume, chest stiffness and cough effectiveness improve then symptoms, quality of life and potentially survival are likely to be better. Importantly, this research would add to the recommendations for the respiratory management of people with neuromuscular disorders by providing much needed evidence to support the use of this technique more widely.

Broad Health ConditionNeuromuscular disease
Motor neurone disease
Muscular dystrophy
Spinal cord injury

Specific Health ConditionNeurological
Neurodegenerative diseases
Physical Medicine / Rehabilitation
Physiotherapy
Respiratory
Other respiratory disorders / diseases

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
VIC

Hospital
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Hospital
Calvary Health Care Bethlehem Ltd - Caulfield

Hospital
The Royal Childrens Hospital - Parkville

Postcode
3084 - Heidelberg

Postcode
3162 - Caulfield

Postcode
3052 - Parkville

Anticipated date of first participant enrolment30/08/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Eligibility

Key inclusion criteria

Neuromuscular disease of >3 months duration
Respiratory system involvement (FVC <80% predicted)

Minimum age14 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

Previously prescribed daily LVR therapy which was performed for a period of >3 consecutive months in the last 12 months, or >6 consecutive weeks within the past 6 months
Medical instability
Inpatient admission for acute respiratory compromise in the preceding 6 weeks
Inability to provide informed consent
Not proficient in English
Requiring invasive ventilation via tracheostomy tube
Previous history or perceived risk factors for pneumothorax
Contraindication or precautions for positive pressure therapy / LVR manoeuvres
Contact details and further information

Sponsor Primary Sponsor Type: Charities/Societies/Foundations
Primary Sponsor Name: Institute for Breathing and Sleep
Primary Sponsor Address: Bowen Centre, Austin Hospital 145 Studley Road, Heidelberg Vic 3084
Primary Sponsor Country: Australia

Trial IDACTRN12615000565549

Contact person for information and recruitmentMs
Nicole Sheers
Austin Health 145 Studley Road Heidelberg Vic 3084
61 3 9496 3877
+ 61 3 9496 5768
Further information iconnicole.sheers@austin.org.au
Australia