Inspiratory muscle training and exercise goal setting to improve functional ability and relieve the symptoms of dyspnoea in advanced cancer patients

ISRCTN	ISRCTN30501538
DOI	https://doi.org/10.1186/ISRCTN30501538
Secondary identifying numbers	EHSDYSPNOEA

Submission date: 18/12/2013
Registration date: 11/04/2014
Last edited: 13/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-breathing-exercises-relieve-breathlessness-caused-by-advanced-cancer

Contact information

Dr Heidi Sowter
Scientific

EHS Faculty
University of Derby
Derby
DE221GB
United Kingdom

Phone	+44 1332 590500
Email	h.sowter@derby.ac.uk

Study information

Study design	Pilot randomised controlled trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	Inspiratory muscle training alongside exercise goal setting will relieve symptoms of dyspnoea for advanced cancer patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/03/2014
Completion date	01/07/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40
Key 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
Key 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
Date of first enrolment	01/03/2014
Date of final enrolment	01/07/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

EHS Faculty

Derby
DE221GB
United Kingdom

Sponsor information

University of Derby (UK)
Not defined

Kedleston Road
Derby
DE221GB
United Kingdom

Phone	+44 1332 590500
Email	h.sowter@derby.ac.uk
"ROR"	https://ror.org/02yhrrk59

Funders

Funder type

University/education

University of Derby (UK)

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

13/04/2017: No publications found in PubMed, verifying study status with principal investigator