Condition category
Not Applicable
Date applied
11/05/2009
Date assigned
15/07/2009
Last edited
15/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.cardiff.ac.uk

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21493747

Publication citations

  1. 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.

Additional files

Editorial Notes