Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure

Investigation of Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure in Chronic Obstructive Pulmonary Diseases

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.

Study Overview

• Status: Completed
• Conditions: Copd; IMT
• Intervention / Treatment: Other: Standard pulmonary rehabilitation programme; Other: Inspiratory muscle training

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • İstanbul, Üsküdar, Turkey, 34668
      • Esra Pehlivan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard pulmonary rehabilitation group (PR); Patients diagnosed with COPD and listed for bronchoscopic procedure.	Other: Standard pulmonary rehabilitation programme; The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.
Experimental: Inspiratory muscle training group (PR+IMT); Patients diagnosed with COPD and listed for bronchoscopic procedure.	Other: Standard pulmonary rehabilitation programme; The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.; Other: Inspiratory muscle training; Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 2 months
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.	Change from baseline at 2 months
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.	Change from baseline at 2 months
Clinical status follow-up after bronchoscopic procedure	Complications and clinical status will be followed up for 1 year after the bronchoscopic procedure.	Change from baseline at 1 year after bronchoscopic procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue severity	The fatigue severity scale: A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity.	Change from baseline at 2 months
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.	Change from baseline at 2 months
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%.	Change from baseline at 2 months
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%.	Change from baseline at 2 months
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).	Change from baseline at 2 months
Pulmonary function tests (PFTs)	PFTs will perform by using the Pony Fx spirometry device, and according to the American Thoracic Society (ATS) guidelines	Change from baseline at 2 months
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.	Change from baseline at 2 months

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COPD; pulmonary rehabilitation; valve; IMT; Bronchoscopic lung volume reduction; coil; bronchoscopic procedure; balloon
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: BLVR_IMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No