Back to resultsInspiratory Muscle Training Efficiency Before Bronchoscopic Procedure
Primary Purpose
Copd, IMT
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory muscle training
Standard pulmonary rehabilitation programme
Sponsored by
About this trial
This is an interventional treatment trial for Copd focused on measuring IMT, COPD, pulmonary rehabilitation, bronchoscopic procedure, Bronchoscopic lung volume reduction, valve, coil, balloon
Eligibility Criteria
Inclusion Criteria:
- Being between the ages of 18-75
- Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to -American Thoracic and European Respiratory Societies (ATS-ERS) and being a candidate patient for bronchoscopic lung volume reduction procedure
- Presence of dyspnea on exertion
- Stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks
- Ability to use a smart phone
Exclusion Criteria:
- Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
- A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- Participation in a pulmonary rehabilitation program within the past 12 months.
Sites / Locations
- Esra PehlivanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard pulmonary rehabilitation group (PR)
Inspiratory muscle training group (PR+IMT)
Arm Description
Patients diagnosed with COPD and listed for bronchoscopic procedure.
Patients diagnosed with COPD and listed for bronchoscopic procedure.
Outcomes
Primary Outcome Measures
Exercise capacity
The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.
Dyspnea perception
Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Respiratory muscle strength
The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.
Clinical status follow-up after bronchoscopic procedure
Complications and clinical status will be followed up for 1 year after the bronchoscopic procedure.
Secondary Outcome Measures
Fatigue severity
The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity.
Physical activity level
The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Anxiety level
Hospital Anxiety Depression scale:The levels of anxiety will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Depression level
Hospital Anxiety Depression scale:The levels of depression will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Quality of life level
Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Pulmonary function tests (PFTs)
PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Peripheral muscle strength measurement
Peripheral muscle strength measurement will be performed on major muscle groups (quadriceps femoris, tibialis anterior, iliopsoas, biceps brachii, triceps, hand grip force) with a digital muscle strength measurement device.
Full Information
NCT ID
NCT05540054
First Posted
September 10, 2022
Last Updated
December 9, 2022
Sponsor
Saglik Bilimleri Universitesi
1. Study Identification
Unique Protocol Identification Number
NCT05540054
Brief Title
Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure
Official Title
Investigation of Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure in Chronic Obstructive Pulmonary Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saglik Bilimleri Universitesi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to examine the effectiveness of inspiratory muscle training (IMT) before bronchoscopic procedure in Chronic Obstructive Pulmonary Patients (COPD). Patients with a diagnosis of COPD, who are listed for a bronchoscopic procedure and referred to the pulmonary rehabilitation (PR) clinic, will be randomly divided into two groups. Standard PR exercise program will be applied to both groups. In addition to the standard program, IMT will be applied to one of the groups. The effect of IMT on exercise program gains will be examined.
Detailed Description
Cases diagnosed with COPD by a chest diseases specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study.
The cases meeting the inclusion criteria will be randomized and divided into two groups, called the standard rehabilitation group (PRGr) and the inspiratory muscle training group (IMTGr).
Initial exercise sessions and all evaluations of all cases will be performed in the hospital. The 2nd and 3rd training repetitions will be held at their homes via online synchronized videoconferencing. The exercise video will be sent to the smart phones of the cases who have completed 3 training sessions. Participants will be called once a week by phone and exercise follow-up will be carried out.
All subjects will continue to exercise 5 days a week for 2 months. The standard PR consists of breathing exercises, peripheral muscle strength and self walking training. In addition, IMT was applied to IMTGr.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Copd, IMT
Keywords
IMT, COPD, pulmonary rehabilitation, bronchoscopic procedure, Bronchoscopic lung volume reduction, valve, coil, balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard pulmonary rehabilitation group (PR)
Arm Type
Experimental
Arm Description
Patients diagnosed with COPD and listed for bronchoscopic procedure.
Arm Title
Inspiratory muscle training group (PR+IMT)
Arm Type
Experimental
Arm Description
Patients diagnosed with COPD and listed for bronchoscopic procedure.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.
Intervention Type
Other
Intervention Name(s)
Standard pulmonary rehabilitation programme
Intervention Description
The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.
Primary Outcome Measure Information:
Title
Exercise capacity
Description
The 6-minute walking test will conduct in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Participants will ask to walk as far as they can. Prior to and following the test, oxygen saturation, heart rate and Borg fatigue rating will measure, and the walking distance will record.
Time Frame
Change from baseline at 2 months
Title
Dyspnea perception
Description
Modified Medical Council Dyspnea score will rate the sensation of dyspnea as the person perceives it.The severity of dyspnea is rated on a scale of 0 to 4."0 point" means no dyspnea perception and "4point" means severe dyspnea perception.
Time Frame
Change from baseline at 2 months
Title
Respiratory muscle strength
Description
The mouth pressure measurement (maximum inspiratory and expiratory pressure) will perform with the Pony Fx spirometry device. Patient will place a rubber mouthpiece with flanges, on the device, exhale/inhale slowly and completely, and then will try to breath in as hard as possible. The patient will allow to rest for about a minute and the maneuver will repeat. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value will obtain.
Time Frame
Change from baseline at 2 months
Title
Clinical status follow-up after bronchoscopic procedure
Description
Complications and clinical status will be followed up for 1 year after the bronchoscopic procedure.
Time Frame
Change from baseline at 1 year after bronchoscopic procedure
Secondary Outcome Measure Information:
Title
Fatigue severity
Description
The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity.
Time Frame
Change from baseline at 2 months
Title
Physical activity level
Description
The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Time Frame
Change from baseline at 2 months
Title
Anxiety level
Description
Hospital Anxiety Depression scale:The levels of anxiety will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Time Frame
Change from baseline at 2 months
Title
Depression level
Description
Hospital Anxiety Depression scale:The levels of depression will asses by Hospital Anxiety Depression Scale (HADS) .The HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21).Several studies suggest a cut-off score of ≥8 to be optimal for best sensitivity and specificity. The HADS has sensitivity and specificity of about 80%, and a predictive validity for identification of about 70%.
Time Frame
Change from baseline at 2 months
Title
Quality of life level
Description
Saint George Respiratory Questionaire (SGRQ) score: The SGRQ ranges from 0 (no impairment of quality of life) to 100 (highest impairment of quality of life).
Time Frame
Change from baseline at 2 months
Title
Pulmonary function tests (PFTs)
Description
PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines
Time Frame
Change from baseline at 2 months
Title
Peripheral muscle strength measurement
Description
Peripheral muscle strength measurement will be performed on major muscle groups (quadriceps femoris, tibialis anterior, iliopsoas, biceps brachii, triceps, hand grip force) with a digital muscle strength measurement device.
Time Frame
Change from baseline at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being between the ages of 18-75
Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to -American Thoracic and European Respiratory Societies (ATS-ERS) and being a candidate patient for bronchoscopic lung volume reduction procedure
Presence of dyspnea on exertion
Stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks
Ability to use a smart phone
Exclusion Criteria:
Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
Participation in a pulmonary rehabilitation program within the past 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeynep Betül Özcan
Phone
+90.0212 409 02 00
Email
zbetulozcan@gmail.com
Facility Information:
Facility Name
Esra Pehlivan
City
İstanbul
State/Province
Üsküdar
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ESRA PEHLİVAN
Phone
02164189616
Email
fztesrakambur@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure
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