NCT00400270

Brief Summary

All patients on the GP asthma database in one practice were invited for an asthma physical-therapy assessment, at baseline. Volunteers satisfying the inclusion criteria ie - aged between 16 and 70, able to understand, read and write English, give informed consent, willing to attend the surgery to take part in the trial and with no other serious conditions - were invited to participate in the study. Patients were randomised either to a control group, receiving 2 more assessments at 6 and 12 months, or for comparison to a group receiving 5 physical-therapy treatments of integrated breathing and relaxation exercises (known as the Papworth Method (PM)). The two groups would then be compared at 6 and 12 months. Hypotheses:

  1. 1.The PM of breathing and relaxation training would improve the quality of life for adult patients with asthma in primary care, compared with patients only receiving usual medical care.
  2. 2.Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.
  3. 3.Respiratory function measurements would improve compared with the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

1 active site

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, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
Last Updated

May 28, 2015

Status Verified

November 1, 2006

First QC Date

November 15, 2006

Last Update Submit

May 27, 2015

Conditions

Keywords

AsthmaRandomised controlled trialBreathing exercisesRelaxation exercisesPrimary care

Outcome Measures

Primary Outcomes (1)

  • Health related Quality of Life as measured by the St George's Respiratory Questionnaire

Secondary Outcomes (3)

  • Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.

  • Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire.

  • Respiratory measurements as measured by spirometry and capnography.

Interventions

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • doctor diagnosed asthma, volunteers from the practice asthma database
  • years of age
  • able to understand, speak and write English
  • willing to give informed consent
  • willing and able to attend the surgery for assessments and treatments

You may not qualify if:

  • serious co-morbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bridge Cottage Surgery

Welwyn, Hertfordshire, AL6 9EF, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Respiration

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Professor Robert West, PhD

    Department of Epidemiology and Public Health, University College London

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 16, 2006

Study Start

October 1, 2004

Study Completion

January 1, 2006

Last Updated

May 28, 2015

Record last verified: 2006-11

Locations