Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Heidi Sowter
ORCID ID
Contact details
EHS Faculty
University of Derby
Derby
DE221GB
United Kingdom
+44 1332 590500
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
Not provided at time of registration
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. Georges 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
+44 1332 590500
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