Breathing and Relaxation Exercises for Asthma: a Randomised Controlled Trial

Asthma Clinical Trial

Official title:

A Physical Therapy Treatment for Adults Diagnosed With Asthma in Primary Care: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400270
• Other study ID #: EC03660
• Status: Completed
• Phase: N/A
• First received: November 15, 2006
• Last updated: May 27, 2015
• Start date: October 2004
• Est. completion date: January 2006

Study information

• Verified date: November 2006
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Breathing and relaxation exercises: the Papworth Method

Locations

Country	Name	City	State
United Kingdom	Bridge Cottage Surgery	Welwyn	Hertfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University College London Hospitals	University College, London, Welwyn Hatfield Primary Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health related Quality of Life as measured by the St George's Respiratory Questionnaire
Secondary	Anxiety and Depression as measured by the Hospital Anxiety and Depression Scale.
Secondary	Symptoms from dysfunctional breathing measured by the Nijmegen Questionnaire.
Secondary	Respiratory measurements as measured by spirometry and capnography.