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Non drug interventions to reduce breathlessness in patients with Chronic Obstructive Pulmonary Disease (Emphysema)

Randomised controlled trial of a non-pharmacological integrated care intervention to reduce breathlessness in patients with severe or very severe chronic obstructive pulmonary disease (COPD)

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000499381
Enrollment
122
Registered
2017-04-06
Start date
2017-03-16
Completion date
2023-02-09
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of this project is examine non drug methods of relieving breathlessness. We will also examine the effects of the non drug interventions on anxiety, depression and quality of life in this patient population with severe chronic obstructive lung disease. We will ask all patients attending the breathlessness clinic to participate. They will be randomly assigned to either start the interventions for breathlessness immediately or delayed start in 8 weeks. All patients will receive current standard of care. They will be asked to complete questionnaires, wear a pedometer (step counter), and to undergo breathing and walking tests. We hope that we can prove non drug management of breathlessness is possible in this patient population.

Interventions

After the clinic assessment, subjects will receive a range of interventions to address their breathlessness. These are derived from evidence based interventions and will include breathing techniques, positions to aid breathing, a hand held fan (supported by a Breathlessness DVD- made by Westmead Hospital based on existing literature supervised by Clinical nurse consultant in respiratory medicine with more than 20 years experience) relaxation and breathing strategies supported by a custom made CD

After the clinic assessment, subjects will receive a range of interventions to address their breathlessness. These are derived from evidence based interventions and will include breathing techniques, positions to aid breathing, a hand held fan (supported by a Breathlessness DVD- made by Westmead Hospital based on existing literature supervised by Clinical nurse consultant in respiratory medicine with more than 20 years experience) relaxation and breathing strategies supported by a custom made CD (made by Westmead Hospital specifically for this clinic with input from a psychologist with greater than 10 years clinical experience), basic advice about pacing activities, a walking program and nutritional advice. Patient handouts have been developed to reinforce the advice given in clinic. Interventions will be individualised for individuals. This will occur as part of the multi-disciplinary team meeting which involves personnel form the disciplines of medicine, nursing, physiotherapy, occupational therapy, dietetics and clinical psychology. Each individuals treatment will be dictated by their clinical needs. Adherence with suggested interventions will be assessed at weekly multidisciplinary meetings and recorded in trial database. Duration of the intervention will be for 8 weeks. Breathing techniques are essentially pursed lip breathing and ‘breathing around the rectangle’ which reduces dynamic hyperinflation. Patients are advised to practise these techniques when they are breathless until the breathlessness episode resolves. Positions essentially involve lean forward postures with arms supported to aid recover from breathless episodes. Relaxation involves assessing patients psychological reaction to breathless episodes and suggesting individualised advice depending on patients’ needs. Basic advice about pacing includes the importance of planning activities of daily living and utilising strategies which allowed the activity to be broken into a number of steps and undertaking each step as breathlessness and energy levels allow. A walking program involves assessing patients physical activity using a pedometer and suggesting goal step counts for patients who are able to increase their step counts. The walking program will be customised to each patients based on their step count during the first week. Nutritional advice involves assessing the patients weight and food intake. Patients with low BMI or who are found to be malnourished or at risk of malnutrition using the Mini Nutritional assessment will receive further input from a dietitian with 15years experience. The delivery of the intervention will be different for patients and will depend on their needs and previous experiences with breathlessness. All patients will receive some advice in the initial clinic appointment. This clinic is delivered by a clinical nurse consultant with more the 20 years’ experience and a respiratory physician with training in palliative care with almost 20 years post graduate experience. The clinic visit lasts approximately one hour. This initial clinic advice will be supported by a range of handouts developed for this clinic. Following initial assessment, patients will receive further advice on the above techniques depending on their need. This advice will be delivered by face to face assessments supported by phone calls. Clinicians involved in delivering this advice include a physiotherapist, occupational therapist and clinical nurse consultant.

Sponsors

Westmead Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

a) Moderate to very severe COPD by GOLD criteria (FEV1 less than 60% predicted; FEV1/FVC ratio less than 70%) b) Severe breathlessness: mMRC greater than or equal to 2 (on mMRC 0-4 scale; ie “On level ground, I walk slower than people of the same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level”) c) Subject is willing and able to be an active participant in their care d) Either completed pulmonary rehabilitation within 1 year or unwilling to attempt pulmonary rehabilitation due to perceived breathlessness (NB randomisation will be stratified for pulmonary rehab completion as these may be clinically different groups and we wish to ensure equal numbers from these categories in each group) e) Informed consent given

Exclusion criteria

a) Bed bound b) Diagnosis of dementia or cognitive impairment c) Subject unwilling or unable to actively participate in trying new interventions to address breathlessness d) No usual medical practitioner (either specialist or general practitioner (GP)) involved in the patient’s care e) Subject unable to comply with study procedures in the opinion of the investigator or the subject’s usual medical team f) Subjects with a current active diagnosis of cancer, primary respiratory disease other than COPD, substance abuse, other uncontrolled medical disorder. g) Subjects with a moderate to severe exacerbation of COPD requiring hospitalisation within the last 4 weeks. h) Subjects with a primary diagnosis of congestive cardiac failure i) Inability to understand sufficient English to complete study procedures or instruments

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026