Inspiratory muscle training in people with Huntington's disease

ISRCTN	ISRCTN90741776
DOI	https://doi.org/10.1186/ISRCTN90741776
Protocol serial number	Version 2
Sponsor	Cardiff University (UK)
Funder	European Huntington's Disease Network ref: seed fund 268

Submission date: 13/01/2013
Registration date: 26/02/2013
Last edited: 24/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
People with neurodegenerative (relating to or characterized by degeneration of nervous tissue) conditions often have reduced breathing ability which impairs their ability to cough. Early findings from an ongoing study in people with Huntingtons disease (HD) show decreased strength in the muscles used to breathe in. This suggests that breathing muscle weakness may underlie the tendency to chest infections as HD progresses. Weak breathing muscles may also influence the ability to carry out physical activity. This study aims to investigate the feasibility of inspiratory (breathing in) muscle training in people with early and mid-stage HD and whether the training programme strengthens the breathing muscles. This small study is needed in order to design future investigations into the effectiveness of inspiratory training and guide physiotherapists in the best management of respiratory problems in people with HD.

Who can participate?
People aged over 18, with early or mid-stage Huntingtons disease, who are able to follow instructions and can commit to six weeks training.

What does the study involve?
The exercise programme involves breathing in through a hand held device that provides resistance to the breath. Twenty people with early and mid-stage HD will be divided into two groups. Each group will carry out the same training, with one group breathing against a higher resistance than the other. Participants will be asked to use the device twice daily for six weeks. We will assess participants before and after the training programme and look to see if there are any changes in breathing strength, cough strength and a functional task. We will also ask 10 people to take part in an interview that will allow them to discuss how they felt about the training programme, the device and whether they felt any benefit from a regular training programme focussed on breathing.

What are the possible benefits and risks of participating?
There may be no direct benefits to anyone taking part in the study. The study is being undertaken to find out whether or not the intervention is beneficial to people with HD. By taking part in the study, participants will be helping us answer this question irrespective of the group they are in. There is low risk associated with inspiratory muscle training. Participants may feel some discomfort during training, but this will not cause any harm. This will be explained to the participants during the initial visit.

Where is the study run from?
Cardiff University (UK)

When is the study starting and how long is it expected to last?
The study started in October 2011 and will run for 2 years

Who is funding the study?
European Huntingtons Disease Network

Who is the main contact?
Una Jones
jonesuf@cardiff.ac.uk

Contact information

Mrs Una Jones
Scientific

School of Healthcare Studies
Cardiff University
Heath Park
Cardiff
CF14 4XN
United Kingdom

Email	jonesuf@cardiff.ac.uk

Study information

Primary study design	Interventional
Study design	Pilot randomised controlled feasibility study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Feasibility and benefit of Inspiratory Muscle Training in people with Huntingtons Disease: a pilot randomised controlled feasibility study
Study acronym	FIMTHD
Study objectives	Inspiratory muscle training increases inspiratory muscle strength in people with Huntingtons Disease (HD)
Ethics approval(s)	Wales Research Ethics Committee, 21/07/2011, ref: 11/WA/0183
Health condition(s) or problem(s) studied	Huntington's disease
Intervention	All subjects will carry out training of 30 breaths through the training device, two times per day, seven days per week. The resistance given to subjects in the training group will be 50% of their maximal inspiratory strength. This can be set automatically by the training device. Resistance given to subjects in the control group will be set at 8cmH2O, which is known to have no training effect (Geddes 2008). The participant will not know to which group they are assigned.
Intervention type	Device
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Inspiratory muscle strength, measured using sniff nasal inspiratory pressure at baseline and end of training.
Key secondary outcome measure(s)	1. Inspiratory muscle strength, measured using maximal inspiratory pressure at baseline and end of training 2. Cough strength, measured by peak cough flow at baseline and end of training 3. Functional activity, measured by 30 second sit to stand at baseline and end of training
Completion date	03/10/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	20
Key inclusion criteria	1. Age > 18, either sex 2. Genetically confirmed HD 3. Capacity to give informed consent 4. Inspiratory muscle strength < 80% predicted for age and height 5. Maintenance of a stable medical regime for 4 weeks prior to initiation of study
Key exclusion criteria	1. History of additional prior neurological condition, such as stroke 2. Uncontrolled psychiatric symptoms 3. History of spontaneous pneumothorax / unstable asthma / chronic respiratory condition
Date of first enrolment	03/10/2011
Date of final enrolment	03/10/2013

Locations

Countries of recruitment

United Kingdom
Wales

Study participating centre

Cardiff University

Cardiff
CF14 4XN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/06/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/06/2016: Publication reference added.