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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Completed
CT.gov ID
NCT03517839
Collaborator
(none)
40
1
2
12.8
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inspiratory muscle trainig
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
The Effect of Inspiratory Muscle Training on Dyspnea Related Kinesiophobia in Chronic Obstructive Pulmonary Disease
Actual Study Start Date :
Jan 2, 2018
Actual Primary Completion Date :
Oct 25, 2018
Actual Study Completion Date :
Jan 28, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Training Group

Other: 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.

Sham Comparator: Control Group

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Breathlessness Beliefs Questionnaire-BBQ [3 Minute (before trainig and after training)]

    Breathlessness Beliefs Questionnaire-BBQ Breathlessness Perception Questionnaire; is a measure evaluating kinesophobia and anxiety due to the breathlessness of 17 questions answered by one's own practice. Patients score from 1 to 5 (I strongly agree). High scores indicate high levels of kinesiophobia and anxiety due to breathlessness.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem Vakıf Univercity Istanbul Eyalet/Yerleşke Turkey 34350

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seda Saka, MSc, PT, Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT03517839
Other Study ID Numbers:
  • bvusska01
First Posted:
May 7, 2018
Last Update Posted:
Apr 9, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Seda Saka, MSc, PT, Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 9, 2019