Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease

NCT ID: NCT03517839

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-02
• Study Completion Date: 2019-01-28

Brief Summary

In our study, it was aimed to evaluate the effect of inspiratory muscle training on fear of movement due to dyspnea in COPD patients. Participants will be randomly assigned to two groups. Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Detailed Description

Pulmonary diseases are a common cause of mortality and morbidity worldwide. Chronic Obstructive Pulmonary Disease (COPD) causes respiratory muscle weakness, but also causes hypercapnia, dyspnoea, oxygen desaturation, and gait disturbances. In COPD, the main symptom is dyspnea and leads to activity limitation. It has been shown that with exercise, the diaphragm workload increases in COPD patients and requires more MIP than healthy humans. This is associated with dyspnea during exercise and tiredness in the respiratory muscles. Dyspnea is defined as the difficulty in breathing of a person. Painful situations are defined as 'kinesiophobia' as a result of physical injuries and fear of repetition of the problem as a result of injury. Similarly, COPD patients avoid themselves from dyspnea-related activities or compensate by reducing the rate of activity. This reduces the severity of the symptom that precedes the symptom that may occur. As a result, fear of movement occurs due to dyspnea. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, reducing the quality of life. In order to increase respiratory muscle strength and endurance, to improve the length tension relationship of respiratory muscles and to increase respiratory capacity, respiratory muscle training is performed by using the training principle of skeletal muscles. In COPD, inspiratory muscle training has been shown in many studies to reduce dyspnoea perception, increase exercise capacity and quality of life.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Training Group

Group Type: EXPERIMENTAL

Inspiratory muscle trainig

Intervention Type: OTHER

Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Control Group

Group Type: SHAM_COMPARATOR

Inspiratory muscle trainig

Intervention Type: OTHER

Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Interventions

Inspiratory muscle trainig

Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• FEV1/FVC<%70
• To be able to read and understand Turkish

Exclusion Criteria

• Having undergone a COPD exacerbation in the last 6 weeks
• Having comorbidities affecting ambulance
• Having cognitive disorders

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Seda Saka

MSc, PT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakıf Univercity

Istanbul, Eyalet/Yerleşke, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

De Peuter S, Janssens T, Van Diest I, Stans L, Troosters T, Decramer M, Van den Bergh O, Vlaeyen JW. Dyspnea-related anxiety: The Dutch version of the Breathlessness Beliefs Questionnaire. Chron Respir Dis. 2011;8(1):11-9. doi: 10.1177/1479972310383592. Epub 2010 Dec 20.

Reference Type: RESULT

PMID: 21172990 (View on PubMed)

Beaumont M, Mialon P, Le Ber C, Le Mevel P, Peran L, Meurisse O, Morelot-Panzini C, Dion A, Couturaud F. Effects of inspiratory muscle training on dyspnoea in severe COPD patients during pulmonary rehabilitation: controlled randomised trial. Eur Respir J. 2018 Jan 25;51(1):1701107. doi: 10.1183/13993003.01107-2017. Print 2018 Jan.

Reference Type: RESULT

PMID: 29371379 (View on PubMed)

Other Identifiers

bvusska01

Identifier Type: -

Identifier Source: org_study_id