Condition category
Cancer
Date applied
18/12/2013
Date assigned
11/04/2014
Last edited
23/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Heidi Sowter

ORCID ID

Contact details

EHS Faculty
University of Derby
Derby
DE221GB
United Kingdom
h.sowter@derby.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EHSDYSPNOEA

Study information

Scientific title

A pilot study to investigate whether inspiratory muscle training and exercise goal setting can improve functional ability and relieve the symptoms of dyspnoea in advanced cancer patients

Acronym

Study hypothesis

Inspiratory muscle training alongside exercise goal setting will relieve symptoms of dyspnoea for advanced cancer patients.

Ethics approval

Pending

Study design

Pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cancer/dyspnoea

Intervention

Participants are randomised to two groups:
1. Inspiratory muscle training (IMT) and goal setting diary:
An 8 week course of self-directed IMT and exercise. Measurements at weeks 1 and 8: 6MWT, inspiratory muscle pressure, spirometry and a questionnaire relating to dyspnoea symptoms.
2. Control group: Do not receive IMT. Offered breathing control techniques and goal setting advice after they have completed their 8 week measurements.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Functional ability as assessed by the 6-minute walk test (6MWT)
2. Relief of dyspnea symptoms and health-related quality of life (HRQoL) as assessed by the St. George’s Respiratory questionnaire (SGRQ)

These are measured at week 1 and week 8.

Secondary outcome measures

1. Change in spirometry measurements
2. Maximal inspiratory mouth pressure (MIP) can be assessed using the IMT devices or using a handheld respiratory pressure meter
3. Feasibility of the intervention will be assessed by monitoring compliance with the self-directed IMT/exercise logged in the weekly diaries and from any pertinent qualitative data gathered from focus groups

These are measured at week 1 and week 8.

Overall trial start date

01/03/2014

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 or above
2. Diagnosed with any type of cancer for which they are having palliative treatment or have ended treatment
3. Showing symptoms of dyspnea (including exertional) as assessed by their physician
4. Ability to engage in gentle exercise

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Patients who have had recent thoracic surgery
2. Patients with mental incapacity unable to give informed consent
3. Patients unable to understand verbal and written information in English
4. Patients who have co-existing moderate or severe chronic obstructive pulmonary disease (COPD)
5. Patients on active treatment for cancer
6. Patients undergoing radical treatment with curative intent

Recruitment start date

01/03/2014

Recruitment end date

01/07/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

EHS Faculty
Derby
DE221GB
United Kingdom

Sponsor information

Organisation

University of Derby (UK)

Sponsor details

Kedleston Road
Derby
DE221GB
United Kingdom
h.sowter@derby.ac.uk

Sponsor type

Not defined

Website

Funders

Funder type

University/education

Funder name

University of Derby (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal Derby Hospital (UK) - Lung cancer and mesothelioma Derby account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes