An interventional study of Inspiratory Muscle Trainer Philips Respironics in Chronic Obstructive Pulmonary Disease, sponsored by Universitas Indonesia. Completed at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Universitas Indonesia · Not applicable, Interventional, and Supportive care
This study aimed to reveal the role of inspiratory muscles exercise using Inspiratory Muscle Trainer (IMT), which is a form of weight training. The pre- and post study of this experiment were conducted in chronic obstructive pulmonary disease (COPD) outpatient clinic during the period of September 2017 until April 2018. Patients were recruited by consecutive sampling. Inclusion criteria were stable COPD patient with The Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria A-D, who has never received prior exercise for pulmonary rehabilitation, and willing to participate in the study. The exclusion criteria included any problem with extremities and cardiovascular disease. Patients underwent an interview about their medical history, tested spirometry using CareFusion®, and the inspiratory muscle strength was assessed using Micro RPM CareFusion®. The St George Respiratory Questionnaire (SGRQ) was used to assess the health status and the 6-Minute Walking Test (6MWT) was conducted to assess functional capacity. Subject exercised using inspiratory muscle trainer (Philips Respironic®) for eight weeks.
Intervention is given using Inspiratory Muscle Trainer Philips Respironic®. Impact on inspiratory muscles strength, health status, and functional capacity are observed. Muscle strength is evaluated using Micro RPM (Respiratory Pressure Meter) Carefusion®. Health status is evaluated using St. George's Respiratory Questionnaire (SGRQ), while functional capacity is evaluated by the 6-Minute Walk Test (6MWT).
Patients were recruited by consecutive sampling. This study was granted ethical approval from the Institutional Review Board (IRB) of the Faculty of Medicine Universitas Indonesia Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Inspiratory muscles strength (Maximal Inspiratory Pressure, MIP) and 6MWT were done at the beginning for basic data and were re-evaluated during the second, fourth, sixth and eighth week (last week). Questionnaire (SGRQ) was done at the initial and end of research.
Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.
4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
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Exclusion Criteria:
Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.
Device: Inspiratory Muscle Trainer Philips Respironics
Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.
Inspiratory muscles strength
This outcome was determined by maximal inspiratory pressure (MIP)
Time frame: Eighth week
Functional capacity
This outcome was determined by 6-minutes walking test
Time frame: Eighth week
Health status
Health status was evaluated using St George Respiratory Questionnaire (SGRQ) SGRQ was a questionnaire designed to measure health impairment in asthmatic and COPD patients. It consists of three parts. First part is symptom, followed by activity and impact. Every question has its own score. The least is zero and the highest is 100. Score is calculated by dividing total score with maximum score for that component and translated into percentage.
Time frame: Eighth week
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2017 to primary completion in Apr 2018, 7 months.
Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 7 months is below that.
Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Universitas Indonesia