Breathing and Relaxation Exercises for Asthma: a Randomised Controlled Trial

• Sponsor: University College London Hospitals (Other)
• Overall Status: Completed
• CT.gov ID: NCT00400270
• Collaborator: Welwyn Hatfield Primary Care Trust (Other), University College, London (Other)
• Enrollment: 56
• Location: 1
• Duration (Months): 15
• Patients Per Site Per Month: 3.7

Study Details

Study Description

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. 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. Anxiety and depression, and symptoms from dysfunctional breathing would reduce compared with the control group.

3. Respiratory function measurements would improve compared with the control group.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Procedure: Breathing and relaxation exercises: the Papworth Method	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Physical Therapy Treatment for Adults Diagnosed With Asthma in Primary Care: a Randomised Controlled Trial
• Study Start Date: Oct 1, 2004
• Study Completion Date: Jan 1, 2006

Outcome Measures

Primary Outcome Measures

1. Health related Quality of Life as measured by the St George's Respiratory Questionnaire []

Secondary Outcome Measures

1. Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale. []

2. Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire. []

3. Respiratory measurements as measured by spirometry and capnography. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• doctor diagnosed asthma, volunteers from the practice asthma database

• 16-70 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

Exclusion Criteria:

• serious co-morbid conditions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bridge Cottage Surgery	Welwyn	Hertfordshire	United Kingdom	AL6 9EF

Sponsors and Collaborators

• University College London Hospitals
• Welwyn Hatfield Primary Care Trust
• University College, London

Investigators

• Study Director: Professor Robert West, PhD, Department of Epidemiology and Public Health, University College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00400270
• Other Study ID Numbers: EC03660
• First Posted: Nov 16, 2006
• Last Update Posted: May 28, 2015
• Last Verified: Nov 1, 2006

• Keywords provided by , ,: Asthma; Randomised controlled trial; Breathing exercises; Relaxation exercises; Primary care
• Additional relevant MeSH terms: Asthma

Study Results

No Results Posted as of May 28, 2015