Clinical trial NCT03739879: Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program
Official title: Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Inspiratory muscle trainer
Pulmonary rehabilitation
COPD
St George Respiratory Questionnaire
6-minute Walking Test
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* stable COPD patient with GOLD criteria A-D,
* never got exercise for pulmonary rehabilitation before,
* willing to participate in the study by signing the written informed consent.

Exclusion Criteria:

* any problem with extremities,
* cardiovascular disease

Primary outcomes:
measure: Inspiratory muscles strength
timeFrame: Eighth week
measure: Functional capacity
timeFrame: Eighth week
measure: Health status
timeFrame: Eighth week
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Outpatient COPD Clinic of Dr. Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
References: