Inspiratory muscle training in patients with Chronic Obstructive Pulmonary Disease (COPD)
| ISRCTN | ISRCTN19258620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19258620 |
| Protocol serial number | RDC01621 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 17/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Lorna Johnson
Scientific
Scientific
King's College Hospital Medical School
Kensington Campus
Camden Hill Road
London
W8 7AH
United Kingdom
| Phone | +44 (0)20 7737 4000 |
|---|---|
| lorna.johnson@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The aim of this study is to investigate the effects of the POWERbreathe on respiratory muscle strength and endurance in people with COPD and also to assess the effects of IMT on breathlessness, functional exercise capacity and quality of life. The results of this study will provide evidence to enable healthcare professionals to advise their patients about the value of this device and may support the introduction of this or similar devices as a therapy for people with COPD. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease |
| Intervention | Not provided at time of registration |
| Intervention type | Other |
| Primary outcome measure(s) |
Mean changes in respiratory muscle strength (cms H2O), respiratory muscle endurance (peak power [cms H2O] and duration [seconds]), shuttle walk distance (metres), Borg scores for breathlessness and CRDQ will be compared between groups using an unpaired t-test or analysis of covariance. Any changes in respiratory muscle strength and endurance will be compared with changes in shuttle walk distance and CRDQ scores using correlation. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. 80 non-hypercapnic patients with moderate (forced expiratory volume [FEV] <40%) will be recruited from consultant hospital and community chest clinics. 2. All patients will be receiving optimum medical management and will have been stable for at least 4 weeks prior to their initial assessment. |
| Key exclusion criteria | 1. Hypercapnia (PaCO2 >45 mmHg) 2. Any patient who is unsuitable for magnetic stimulation (pacemakers, artificial heart valves, metal prosthesis). |
| Date of first enrolment | 01/03/2000 |
| Date of final enrolment | 01/03/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
King's College Hospital Medical School
London
W8 7AH
United Kingdom
W8 7AH
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? |
|---|---|---|---|---|---|
| Abstract results | 01/12/2003 | No | No |
