- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03137524
Fan Therapy in COPD Patients
A Pilot Study of Hand-held Fan Therapy in Breathless Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary Disease (COPD) is a common smoking related lung disease. The main symptom in breathlessness.
Pulmonary Rehabilitation (PR) - a supervised group exercise and education class - is an effective intervention in COPD to reduce symptoms, improve exercise performance and prevent exacerbations. However some COPD patients are unable to to effectively exercise as they are limited by their breathlessness, despite optimal medical management. By reducing their physical activity to avoid the onset of breathlessness, they become deconditioned and then further attempts at exercise make them more breathless, leading to an inactivity cycle.
There is a growing evidence base regarding the use of hand hold fan therapy or air therapy to relieve breathlessness at rest. Limited studies have looked at the use of fan therapy during exercise, and its role on exercise capacity and recovery time, provisional results which indicate it may also be useful during activity. Logically you might expect patients who are less breathless to be able to exercise more, or recover quicker.
This study aims to investigate the effects a hand held fan will have on sensation of breathlessness and exercise capacity in patients with COPD. This will involve participants undertaking a standardised field walking test ( 6 minute walk test) with and with out the fan and then comparing the distance covered and how they felt during and after exercise. This will better inform how we structure exercise and advice to these patients in the future to empower patients limited by breathlessness.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, SE5 9RS
- King's College Hospital NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chronic Obstructive Pulmonary Disease (Forced Expiratory volume in 1 second (FEV1)/Vital capacity ratio < 70%, with an observed respiratory impairment ( Global initiative for Chronic Obstructive Lung Disease (GOLD) stage II-IV: < 79% FEV1 predicted)
- Age > 18 years old
- Exertional breathlessness with a Medical Research Council (MRC) breathlessness scale greater of equal to 2
Exclusion Criteria:
- Recent exacerbation of COPD symptoms requiring antibiotics within the preceding 4 weeks
- Significant cardiovascular or peripheral disease that could influence exercise tolerance and ability to perform exercise test
- Unable to hold fan to face and mobilise
- On Long Term Oxygen Therapy or fulfils criteria for ambulatory oxygen
- Lack of English Language Competency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Intervention
|
|
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Experimental: Hand Held Fan Therapy
|
Hand-Held fan therapy used to generate airflow directed to face during specific exercise test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breathlessness as measured on the Numerical Rating Scale (NRS)
Time Frame: Change from baseline measurement of breathlessness on the NRS to the measurement of breathlessness on NRS after a 6 minute walk test
|
Units on a Scale
|
Change from baseline measurement of breathlessness on the NRS to the measurement of breathlessness on NRS after a 6 minute walk test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Walking distance
Time Frame: 6 minutes
|
as measured during a 6 minute walk test
|
6 minutes
|
|
Oxygen Saturation Levels
Time Frame: 6 minutes
|
peripheral oxygen saturation levels as measured during a 6 minute walk test
|
6 minutes
|
|
Recovery time
Time Frame: in minutes, anticipate no longer than 10minutes
|
Time in mins taken for sensation of breathlessness to return to baseline levels after completion of a 6 minute walk test
|
in minutes, anticipate no longer than 10minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Dr Cartwright, BSc, MSc, PhD, City, University of London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 218706
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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