Plain English Summary
Background and study aims
Fibromyalgia is a long-term condition of unknown cause in which patients suffer from a variety of symptoms, such as pain, muscle weakness, or tiredness. Muscle weakness can also affect the heart and lung muscles and thus can lead to poor quality of life. We want to see how well the breathing training works in increasing the strength of the lung muscles and also in alleviating symptoms such as pain and tiredness.
Who can participate?
Adult women who have been diagnosed with fibromyalgia.
What does the study involve?
Women were randomly allocated to one of two groups: experimental or control group. Women in the experimental group received 12 weeks of breathing training, while the control group did not receive the training. We checked the effectiveness of the breathing technique at the start of the study, after 12 weeks and immediately after the end of the training.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
Not provided at time of registration.
When is study starting and how long is it expected to run for?
January 2012 to April 2012.
Who is funding the study?
University of Évora (Portugal).
Who is the main contact?
Prof Pablo Tomas-Carus
ptc@uevora.pt
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled trial investigating the effects of 12 weeks of breathing training techniques on respiratory muscle efficiency, pain, health-related quality of life and intake of drugs in sedentary women with fibromyalgia
Acronym
Study hypothesis
1. 12 weeks of breathing training may lead to changes in respiratory muscle efficiency, pain and health-related quality of life, and intake of drugs of sedentary women with fibromyalgia
2. Gains in respiratory muscle efficiency are related to improvements in pain intensity of tender points and self-reported pain of sedentary women with fibromyalgia
3. Gains in respiratory muscle efficiency are related to improvements in health-related quality of life and reduced intake of specific drugs of sedentary women with fibromyalgia
4. Gains in respiratory muscle efficiency are related to reduction of intake of specific drugs of sedentary women with fibromyalgia
Ethics approval
University of Évora Ethics Committee, June 2012, ref: 1200
Study design
Single-centre interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Syndrome of fibromyalgia
Intervention
The breathing therapy consisted of 30 minutes/session for 7-times/week (1-time supervised by an expert in breathing training techniques, and 6-times unsupervised at home with regard to audiovisual training) and for 12 weeks. Each session included five breathing exercises (3 minutes for each) were used in the form of circuit: an exercise on awareness of breathing, an exercise on costal expansion, and three exercises on diaphragmatic breathing. This circuit was performed twice, with a total time of 30 minutes per session
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The primary endpoint with respect to effects of breathing training techniques on respiratory muscle efficiency. Therefore, the functional respiratory examination was measured with global body plestimograph. The standard parameters of ventilatory pattern were recorded: minute ventilation (VE), respiratory frequency (f), tidal volume (VT) and the ratio of inspiratory and the total times (Ti/Ttot). In the study of muscle efficiency, two parameters were monitored: the maximal inspiratory pressure (MIP) and maximum occlusion pressure (P0.1). The maximal expiratory pressure (MEP) was measured as a component of the study of evaluation of respiratory muscles. Measurements were taken at baseline and post-intervention at 12 weeks.
Secondary outcome measures
1. Pain was evaluated by the rheumatologist as follows:
1.1. Pain in tender points with digital dolorimeter
1.2. Widespread pain index (WPI) and total symptom severity (SS) by applying the 2010 ACR preliminary classification criteria diagnoses of fibromyalgia
1.3. Overall pain by using a visual analog scale (VAS)
2. Health-related quality of life (HRQoL) was evaluated using the Portuguese language version of the Short Form 36 Health Survey (SF-36)
3. The Portuguese version of the Fibromyalgia Impact Questionnaire (FIQ) was used to evaluate the impact of FM on patients physical and mental health
4. Type and number of drugs taken in relation to fibromyalgia were recorded
Overall trial start date
23/01/2012
Overall trial end date
30/04/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Diagnosis of fibromyalgia by a rheumatologist
2. Non-smokers and not consumers of alcohol
3. Age between 25 and 70 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
48 potentially eligible, 35 gave consent (exercise group: 18; control group: 17)
Participant exclusion criteria
1. History of severe trauma
2. Peripheral nerve entrapment
3. Inflammatory rheumatic diseases
4. Severe psychiatric illness
5. Respiratory diseases
6. Other diseases that prevent breathing training
7. Pregnancy
8. Attend to another psychological or physical therapy
Recruitment start date
23/01/2012
Recruitment end date
30/04/2012
Locations
Countries of recruitment
Portugal
Trial participating centre
University of Évora
Évora
7000-671
Portugal
Sponsor information
Organisation
University of Évora (Portugal)
Sponsor details
Department of Sports and Health
Research Centre in Sports Sciences
Health and Human Development
Romão Ramalho
59 (CLV)
Évora
7000-671
Portugal
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Évora (Portugal)
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