Contact information
Type
Scientific
Primary contact
Dr Stephanie Enright
ORCID ID
Contact details
Deapartment of Physiotherapy
School of health Care Studies
Cardiff University
Cardiff
CF14 4XN
United Kingdom
+44 (0)29 2068 7558
enrights@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0622839
Study information
Scientific title
The effect of inspiratory muscle training intensities on pulmonary function and exercise capacity in healthy subjects: a randomised controlled trial
Acronym
Study hypothesis
Inspiratory muscle training performed at 80%, 60% and 40% of maximal intensity will result in changes in inspirator muscle function with 80% and 40% producing positive effects on exercise capacity and 80% producing positive effect on lung volumes.
Ethics approval
School of Health Care Studies R&D Committee approved on the 27th August 2007 (ref: REG2707)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pulmonary function, exercise capacity
Intervention
Intervention: inspiratory muscle training at 80%, 60%, 40% of maximum sustained inspiratory pressure. The training intervention was performed 3 times a week over an eight week period. Each training session took 30 minutes to complete.
Control: no participation in any form of training throughout the duration of the study.
The control group and the three training groups were assessed at the begining of the trial (the initial screening visit) and all measurements (excluding body composition) were repeated at the trial conclusion (at the end of an eight week training period for the three training groups and the control group).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Lung volumes (vital capacity and total lung capacity)
2. Exercise capacity (cycle ergometry)
3. Inspiratory pressure
Measurements were taken before the training intervention and then at the cessation of training (i.e., following the 8 weeks of training).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
04/02/2008
Overall trial end date
09/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy, moderately trained subjects (aged 18 - 27 years, either sex). The rationale for the age range was so data could be compared to those obtained in a population of adults with cystic fibrosis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Pre-existing respiratory disease
Recruitment start date
04/02/2008
Recruitment end date
09/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Deapartment of Physiotherapy
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
Heath Park Campus
Cardiff
CF14 4XN
United Kingdom
+44 (0)29 2068 7558
enrights@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Physiotherapy Research Foundation (UK) - Chartered Society of Physiotherapy (ref: PRF/97/5)
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21493747
Publication citations
-
Results
Enright SJ, Unnithan VB, Effect of inspiratory muscle training intensities on pulmonary function and work capacity in people who are healthy: a randomized controlled trial., Phys Ther, 2011, 91, 6, 894-905, doi: 10.2522/ptj.20090413.