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Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Inspiratory Muscle Trainer Philips Respironics
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring Inspiratory muscle trainer, Pulmonary rehabilitation, COPD, St George Respiratory Questionnaire, 6-minute Walking Test

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient COPD Clinic of Dr. Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inspiratory muscle training (IMT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Inspiratory muscles strength
This outcome was determined by maximal inspiratory pressure (MIP)
Functional capacity
This outcome was determined by 6-minutes walking test
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.

Secondary Outcome Measures

Full Information

First Posted
November 6, 2018
Last Updated
November 9, 2018
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT03739879
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Inspiratory muscle trainer, Pulmonary rehabilitation, COPD, St George Respiratory Questionnaire, 6-minute Walking Test

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training (IMT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Trainer Philips Respironics
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiratory muscles strength
Description
This outcome was determined by maximal inspiratory pressure (MIP)
Time Frame
Eighth week
Title
Functional capacity
Description
This outcome was determined by 6-minutes walking test
Time Frame
Eighth week
Title
Health status
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Outpatient COPD Clinic of Dr. Cipto Mangunkusumo Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectivity of Inspiratory Muscle Trainer in the Chronic Obstructive Pulmonary Disease Rehabilitation Program

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