NCT03137524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2017

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

April 24, 2017

Last Update Submit

August 3, 2017

Conditions

Keywords

Fan or Air Therapy

Outcome Measures

Primary Outcomes (1)

  • Breathlessness as measured on the Numerical Rating Scale (NRS)

    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 Outcomes (3)

  • Walking distance

    6 minutes

  • Oxygen Saturation Levels

    6 minutes

  • Recovery time

    in minutes, anticipate no longer than 10minutes

Study Arms (2)

Hand Held Fan Therapy

EXPERIMENTAL
Device: Hand Held Fan Therapy

No Intervention

NO INTERVENTION

Interventions

Hand-Held fan therapy used to generate airflow directed to face during specific exercise test

Hand Held Fan Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College Hospital NHS Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Martin Dr Cartwright, BSc, MSc, PhD

    City, University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Single Centre Pilot study using a randomised controlled crossover design (aka randomised A-B single-subject design).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2017

First Posted

May 2, 2017

Study Start

May 24, 2017

Primary Completion

July 26, 2017

Study Completion

July 26, 2017

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations