Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure

NCT05540054 | Completed

• 1 other identifier: BLVR_IMT
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd; IMT

Keywords

IMT; COPD; pulmonary rehabilitation; bronchoscopic procedure; Bronchoscopic lung volume reduction; valve; coil; balloon

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Fatigue severity

  Change from baseline at 2 months

• Physical activity level

  Change from baseline at 2 months

• Anxiety level

  Change from baseline at 2 months

• Depression level

  Change from baseline at 2 months

• Quality of life level

  Change from baseline at 2 months

Study Arms (2)

Standard pulmonary rehabilitation group (PR)

EXPERIMENTAL

Patients diagnosed with COPD and listed for bronchoscopic procedure.

Other: Standard pulmonary rehabilitation programme

Inspiratory muscle training group (PR+IMT)

EXPERIMENTAL

Patients diagnosed with COPD and listed for bronchoscopic procedure.

Other: Inspiratory muscle training; Other: Standard pulmonary rehabilitation programme

Interventions

Inspiratory muscle training OTHER

Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device.

Inspiratory muscle training group (PR+IMT)

Standard pulmonary rehabilitation programme OTHER

The standard PR consisted of breathing exercises, peripheral muscle strengthening and self walking training.

Inspiratory muscle training group (PR+IMT); Standard pulmonary rehabilitation group (PR)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to use a smart phone

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 27, 2023

Record last verified: 2022-09

Locations

TU (1)