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Fan Therapy in COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03137524
Recruitment Status : Completed
First Posted : May 2, 2017
Last Update Posted : August 4, 2017
Sponsor:
Collaborator:
King's College Hospital NHS Trust
Information provided by (Responsible Party):
City, University of London

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.


Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Breathlessness Device: Hand Held Fan Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single Centre Pilot study using a randomised controlled crossover design (aka randomised A-B single-subject design).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Hand-held Fan Therapy in Breathless Chronic Obstructive Pulmonary Disease (COPD) Patients
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : July 26, 2017
Actual Study Completion Date : July 26, 2017


Arm Intervention/treatment
Experimental: Hand Held Fan Therapy Device: Hand Held Fan Therapy
Hand-Held fan therapy used to generate airflow directed to face during specific exercise test

No Intervention: No Intervention



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Walking distance [ Time Frame: 6 minutes ]
    as measured during a 6 minute walk test

  2. Oxygen Saturation Levels [ Time Frame: 6 minutes ]
    peripheral oxygen saturation levels as measured during a 6 minute walk test

  3. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03137524


Locations
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United Kingdom
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
City, University of London
King's College Hospital NHS Trust
Investigators
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Principal Investigator: Martin Dr Cartwright, BSc, MSc, PhD City, University of London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: City, University of London
ClinicalTrials.gov Identifier: NCT03137524    
Other Study ID Numbers: 218706
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by City, University of London:
Fan or Air Therapy
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Dyspnea
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory