NCT00515840

Brief Summary

Breathing retraining supervised by a physiotherapist will result in improvements in the quality of life and asthma control of patients treated for asthma in the community with symptoms suggestive of dysfunctional breathing. To investigate the effects of breathing retraining on clinical and physiological parameters of asthma control, to identify the characteristics of patients who benefit, to perform a health economic evaluation.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_3 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

4.2 years

First QC Date

August 13, 2007

Last Update Submit

November 4, 2015

Conditions

AsthmaRespiratory

Outcome Measures

Primary Outcomes (1)

  • Change in AQLQ scores between intervention and control groups in subjects with positive NQ screening scores 1 month post intervention Change in AQLQ scores between intervention groups of subjects with positive and negative NQ screening scores

    Dec 2006

Secondary Outcomes (1)

  • Changes in bronchial hyperresponsiveness(PC 20), sputum eosinophil counts and exhaled NO between intervention and control groups in subjects with positive and negative NQ screening scores Change in ACQ Score between the intervention and the control gr

    Dec 2007

Study Arms (1)

1

SHAM COMPARATOR

equal time with health care professional (asthma nurse)

Other: Physiotherapist

Interventions

PhysiotherapistOTHER

Physiotherapist administered breathing retraining programme

1

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Asthma diagnosis in medical records
  • Age 17-70 yrs.
  • One or more prescription for asthma medication in previous 12 months
  • Impaired asthma related quality of life (AQLQ score \<5.5)

You may not qualify if:

  • COPD
  • Unstable or under-treated asthma at enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Physical Therapists

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Mike Thomas

    University of Aberdeen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Governance Manager

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

October 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

November 5, 2015

Record last verified: 2015-11