Condition category
Respiratory
Date applied
14/04/2016
Date assigned
15/04/2016
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Asthma is a common long-term health condition caused by inflammation of the small tubes (bronchi) that carry air in and out of the lungs. Symptoms vary in severity and include coughing, wheezing, a tightness in the chest and feeling breathless. It occurs when the sufferer comes in contact with something that irritates their lungs – a trigger - causing their airways to narrow and an increase in the production of phlegm in their airways. Common triggers include house dust mites, animal fur, pollen, cigarette smoke, exercise and viral infections (such as a cold). Sometimes, as it can be more difficult for asthma sufferers to take a breath, the respiratory muscles (the muscles that help a person to breathe) can become overworked, or overloaded. This can be alleviated though physiotherapy treatments (interventions) that reduce the demand on the muscles or strengthen them. There is some scientific literature demonstrating that strengthening the muscles that help a person to breathe in (the inspiratory muscles) does help to reduce symptoms. However, more scientific evidence is needed. This study looks at the effects of inspiratory muscle training (IMT) on the strength, endurance and function of these muscles, as well as a person’s quality of life, the number of hospital admissions, and any worsening of a patient’s condition.

Who can participate?
Asthma sufferers aged between 20-70.

What does the study involve?
Participants are randomly allocated to one of two groups, a IMT group or a control group. All participants attend two educational sessions on asthma care and information about the respiratory system, the symptoms of asthma and what can influence it, how to prevent a worsening of symptoms, training on good breathing techniques and information regarding regular physical activity. Those in the IMT group also receive IMT training twice a day, over 5 days for a period of 8 weeks. All participants are assessed before the study begins, after the 8 week study period and then again 3 months later.

What are the possible benefits and risks of participating?
The participant receives a report with the results of lung function tests and inspiratory muscle strength for his/her knowledge and medical care and the results of this study can be used in future studies contributing to the advancement of science. Potential risks include a shortness of breath and faster heart rate during the test.

Where is the study run from?
Federal University of Minas Gerais (Brazil)

When is the study starting and how long is it expected to run for?
March 2014 to February 2018

Who is funding the study?
National Council for Scientific and Technological Development (Brazil)

Who is the main contact?
Professor Verônica Franco Parreira
veronicaparreira@yahoo.com.br

Trial website

Contact information

Type

Scientific

Primary contact

Prof Verônica Franco Parreira

ORCID ID

http://orcid.org/0000-0003-0374-9319

Contact details

Departamento de Fisioterapia - EEFFTO
Avenida Antonio Carlos
6627
Belo Horizonte - MG
31.270-901
Brazil
+553134094794
veronicaparreira@yahoo.com.br

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effects of a high intensity inspiratory muscle training program versus an education program on inspiratory muscle strengh and endurance, functional capacity and quality of life in patients with asthma: a randomised controlled trial.

Acronym

Study hypothesis

Inspiratory muscle training (IMT) associated to an educational program improves inspiratory muscle strength and endurance, functional capacity and quality of life in patients with asthma more than only an educational program.

Ethics approval

Universidade Federal de Minas Gerais Ethics Committee, 23/10/2014, ref: CAAE: 35493714.1.0000.5149

Study design

Randomised controlled trial - single centre

Primary study design

Interventional

Secondary study design

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Asthma

Intervention

Description of intervention:
1. IMT Group (IMT plus educational program)
2. Control Group (educational program)

Inspiratory muscle training (IMT): six sets of 30 breaths per day, divided in twice per day, five days a week, during eight weeks, with PowerBreathe K3. Minimum load of 50% of maximal inspiratory pressure, weekly adjusted.

Educational program: two individual (or with family) sessions on asthma care, including: knowledge about respiratory system, symptoms of asthma and factors that influence it, preventive strategies to avoid exacerbations, training about correct inhalation technique, encouragement for regular physical activity.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Inspiratory muscle strength - maximal inspiratory pressure assessed by a digital manovacuometer
2. Inspiratory muscle endurance – time, volume, flow, work and power assessed by an electronic tapered flow resistive loading device
3. Functional capacity – maximal distance covered during shuttle walking test
4. Quality of life - Brazilian version of the Asthma Quality of Life Questionnaire

Assessed at baseline, 8 weeks and 3 months.

Secondary outcome measures

1. Lung function: Forced expiratory volume in the first second-FEV1, forced vital capacity-FVC and peak expiratory flow-PEF
2. Hospital admissions
3. Number of exacerbations

Assessed at baseline, 8 weeks and 3 months.

Overall trial start date

03/03/2014

Overall trial end date

28/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with asthma according to GINA - an increase in FEV1 of > 12% and 200mL after administration of a bronchodilator indicates reversible airflow limitation consistent with asthma
2. Age between 20 and 70 years old
3. No smokers
4. Asthma control test above 18 points; 5.- Auto report of absence of cardiac and neurological diseases

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

40 partcipants

Participant exclusion criteria

1. Fever
2. Flu symptoms or respiratory infection in the seven days prior to evaluation
3. Orthopedic and neurological problems
4. Inability to understand or carry out any study procedures

Recruitment start date

06/04/2015

Recruitment end date

31/07/2017

Locations

Countries of recruitment

Brazil

Trial participating centre

Federal University of Minas Gerais
31.270-901
Brazil

Sponsor information

Organisation

Federal University of Minas Gerais

Sponsor details

Physiotherapy Department.
Avenida Antônio Carlos
6627. Pampulha.
Belo Horizonte
31.270-901
Brazil
+55 31 3409-5000
info@ufmg.br

Sponsor type

University/education

Website

https://www.ufmg.br

Funders

Funder type

Government

Funder name

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Alternative name(s)

National Council for Scientific and Technological Development, CNPq

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Brazil

Results and Publications

Publication and dissemination plan

Intention to publish date

28/02/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/05/2016: Internal review