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21 March 2013
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| [ Print-friendly version ] |
| Inspiratory muscle training in people with Huntington's disease |
| ISRCTN | ISRCTN90741776 |
| DOI | 10.1186/ISRCTN90741776 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Inspiratory muscle training in people with Huntington's disease |
| Scientific title | Feasibility and benefit of Inspiratory Muscle Training in people with Huntington’s Disease: a pilot randomised controlled feasibility study |
| Acronym | FIMTHD |
| Serial number at source | version 2 |
| Study hypothesis | Inspiratory muscle training increases inspiratory muscle strength in people with Huntington’s Disease (HD) |
| Lay summary |
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 Huntington’s 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 Huntington’s 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? The study has been set up by Cardiff University. 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? The study is funded by the European Huntington’s Disease Network. Who is the main contact? Una Jones jonesuf@cardiff.ac.uk |
| Ethics approval | Wales Research Ethics Committee, 21/07/11, ref: 11/WA/0183 |
| Study design | Pilot randomised controlled feasibility study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Huntington's disease |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 03/10/2011 |
| Anticipated end date | 03/10/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20 |
| Interventions |
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. |
| Primary outcome measure(s) | Inspiratory muscle strength, measured using sniff nasal inspiratory pressure at baseline and end of training. |
| 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 |
| Sources of funding | European Huntington's Disease Network ref: seed fund 268 |
| Trial website | |
| Publications | |
| Contact name | Mrs Una Jones |
| Address |
School of Healthcare Studies
Cardiff University Heath Park |
| City/town | Cardiff |
| Zip/Postcode | CF14 4XN |
| Country | United Kingdom |
| jonesuf@cardiff.ac.uk | |
| Sponsor | Cardiff University (UK) |
| Address |
Research and commercial division
30-36 Newport Road |
| City/town | Cardiff |
| Zip/Postcode | CF24 0DE |
| Country | United Kingdom |
| Tel | +44 (0)29 2087 9277 |
| Fax | +44 (0)29 2087 4189 |
| resgov@cardiff.ac.uk | |
| Sponsor website: | http://www.cardiff.ac.uk/ |
| Date applied | 13/01/2013 |
| Last edited | 26/02/2013 |
| Date ISRCTN assigned | 26/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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