Effects of breathing training on respiratory muscle efficiency, pain, health-related quality of life and intake of drugs in sedentary women with fibromyalgia
| ISRCTN | ISRCTN37081460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37081460 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/09/2012
- Registration date
- 27/10/2014
- Last edited
- 16/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
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
Contact information
Scientific
University of Évora
Department of Sports and Health
Research Centre in Sports Sciences
Health and Human Development
Évora
7000-671
Portugal
Study information
| Study design | Single-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | University of Évora Ethics Committee, June 2012, ref: 1200 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 23/01/2012 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 48 potentially eligible, 35 gave consent (exercise group: 18; control group: 17) |
| Key inclusion criteria | 1. Diagnosis of fibromyalgia by a rheumatologist 2. Non-smokers and not consumers of alcohol 3. Age between 25 and 70 years |
| Key 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 |
| Date of first enrolment | 23/01/2012 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- Portugal
Study participating centre
7000-671
Portugal
Sponsor information
University/education
Department of Sports and Health
Research Centre in Sports Sciences
Health and Human Development
Romão Ramalho
59 (CLV)
Évora
7000-671
Portugal
| Website | http://www.uevora.pt/ |
|---|---|
"ROR" |
https://ror.org/02gyps716 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2018 | Yes | No |
Editorial Notes
16/04/2018: Publication reference added.
