Fan Therapy in COPD Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease, Breathlessness
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hand Held Fan Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Fan or Air Therapy
Eligibility Criteria
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
Sites / Locations
- King's College Hospital NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hand Held Fan Therapy
No Intervention
Arm Description
Outcomes
Primary Outcome Measures
Breathlessness as measured on the Numerical Rating Scale (NRS)
Units on a Scale
Secondary Outcome Measures
Walking distance
as measured during a 6 minute walk test
Oxygen Saturation Levels
peripheral oxygen saturation levels as measured during a 6 minute walk test
Recovery time
Time in mins taken for sensation of breathlessness to return to baseline levels after completion of a 6 minute walk test
Full Information
NCT ID
NCT03137524
First Posted
April 24, 2017
Last Updated
August 3, 2017
Sponsor
City, University of London
Collaborators
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03137524
Brief Title
Fan Therapy in COPD Patients
Official Title
A Pilot Study of Hand-held Fan Therapy in Breathless Chronic Obstructive Pulmonary Disease (COPD) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
July 26, 2017 (Actual)
Study Completion Date
July 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City, University of London
Collaborators
King's College Hospital NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Breathlessness
Keywords
Fan or Air Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Single Centre Pilot study using a randomised controlled crossover design (aka randomised A-B single-subject design).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hand Held Fan Therapy
Arm Type
Experimental
Arm Title
No Intervention
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Hand Held Fan Therapy
Intervention Description
Hand-Held fan therapy used to generate airflow directed to face during specific exercise test
Primary Outcome Measure Information:
Title
Breathlessness as measured on the Numerical Rating Scale (NRS)
Description
Units on a Scale
Time Frame
Change from baseline measurement of breathlessness on the NRS to the measurement of breathlessness on NRS after a 6 minute walk test
Secondary Outcome Measure Information:
Title
Walking distance
Description
as measured during a 6 minute walk test
Time Frame
6 minutes
Title
Oxygen Saturation Levels
Description
peripheral oxygen saturation levels as measured during a 6 minute walk test
Time Frame
6 minutes
Title
Recovery time
Description
Time in mins taken for sensation of breathlessness to return to baseline levels after completion of a 6 minute walk test
Time Frame
in minutes, anticipate no longer than 10minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Dr Cartwright, BSc, MSc, PhD
Organizational Affiliation
City, University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34760995
Citation
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.
Results Reference
derived
Learn more about this trial
Fan Therapy in COPD Patients
We'll reach out to this number within 24 hrs