Chronic Obstructive Pulmonary DiseaseNCT03137524
Fan Therapy in COPD Patients
A study testing Hand Held Fan Therapy in people with Chronic Obstructive Pulmonary Disease and Breathlessness, run by City, University of London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Breathlessness
- What is being tested?
- Hand Held Fan Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2017to 26 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Hand Held Fan Therapy
- Keywords
- Fan or Air Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Held Fan TherapyDevice
Hand-Held fan therapy used to generate airflow directed to face during specific exercise test
| Study group | Role | What they receive |
|---|---|---|
| Hand Held Fan Therapy | Experimental | Not described Receives: Device: Hand Held Fan Therapy |
| No Intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness as measured on the Numerical Rating Scale (NRS)
Units on a Scale
Measured: Change from baseline measurement of breathlessness on the NRS to the measurement of breathlessness on NRS after a 6 minute walk test
Secondary outcomes (3)
Walking distance
as measured during a 6 minute walk test
Measured: 6 minutes
Oxygen Saturation Levels
peripheral oxygen saturation levels as measured during a 6 minute walk test
Measured: 6 minutes
Recovery time
Time in mins taken for sensation of breathlessness to return to baseline levels after completion of a 6 minute walk test
Measured: in minutes, anticipate no longer than 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2017
- Study start24 May 2017
- Primary completion26 Jul 2017
- Study completion26 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single Centre Pilot study using a randomised controlled crossover design (aka randomised A-B single-subject design).
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- City, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Martin Dr Cartwright, BSc, MSc, PhD, Principal investigator, City, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137524
- Sponsor's protocol ID
- 218706
- Status last verified
- Aug 2017
- First submitted
- 24 Apr 2017
- Last updated
- 4 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Long A, Cartwright M, Reilly CC. Impact of fan therapy during exercise on breathlessness and recovery time in patients with COPD: a pilot randomised controlled crossover trial. ERJ Open Res. 2021 Nov 8;7(4):00211-2021. doi: 10.1183/23120541.00211-2021. eCollection 2021 Oct.
PubMed 34760995
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Hand-held Fan Therapy in Breathless Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT03137524
- Acronym / sponsor ID
- 218706
- Keywords
- Fan or Air Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- City, University of LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 24 May 2017 (actual)
- Primary completion
- 26 Jul 2017 (actual)
- Study completion
- 26 Jul 2017 (actual)
- First posted
- 2 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Centre Pilot study using a randomised controlled crossover design (aka randomised A-B single-subject design).
| Arm | Type | Receives |
|---|---|---|
| Hand Held Fan Therapy | Experimental | Device: Hand Held Fan Therapy |
| No Intervention | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Held Fan TherapyHand-Held fan therapy used to generate airflow directed to face during specific exercise test | Device | Hand Held Fan Therapy |
Primary outcome
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
3 secondary outcomes
Walking distance
Time frame: 6 minutes
Oxygen Saturation Levels
Time frame: 6 minutes
Recovery time
Time frame: in minutes, anticipate no longer than 10minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2017.
- Derived from this study: PubMed 34760995Long A, Cartwright M, Reilly CC. Impact of fan therapy during exercise on breathlessness and recovery time in patients with COPD: a pilot randomised controlled crossover trial. ERJ Open Res. 2021 Nov 8;7(4):00211-2021. doi: 10.1183/23120541.00211-2021. eCollection 2021 Oct.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Dr Cartwright, BSc, MSc, PhD principal investigator
City, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Held Fan Therapy in people with Chronic Obstructive Pulmonary Disease and Breathlessness, run by City, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2017.