Effects of Inspiratory Muscle Training on Shortness of Breath (Dyspnea) and Postural Control in Patients With COPD

NCT03240640 | Completed DMC

• 1 other identifier: S58513
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Shortness of breath (dyspnea) is an important symptom during physical exertion in patients with chronic obstructive pulmonary disease (COPD) and is related to respiratory muscle weakness. Dyspnea is a multidimensional sensation. The sensory perceptual domain (perceived dyspnea intensity) has been study extensively. The perception of respiratory distress (unpleasantness of dyspnea) has not received as much attention. Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle function and reduce dyspnea intensity. Balance impairments increasing the risk of falling is another recognized problem in patients with COPD. Postural balance has been shown to be especially impaired in patients with COPD who have pronounced respiratory muscle weakness. Improvements in respiratory muscle function might improve balance control in patients. Respiratory Muscle Metaboreflex is known as respiratory muscle work during exercise reflexively induces sympathetically mediated vasoconstrictor activity, there by compromising blood flow and oxygen delivery to active limb and respiratory muscles. Eight weeks of controlled IMT is hypothesized to reduce both intensity as well as unpleasntness domain of dyspnea perception, improve postural control and improves blood flow and oxygen delivery to limb muscles in patients with COPD who have pronounced respiratory muscle weakness.

Conditions

Copd; Inspiratory Muscle Weakness

Keywords

Inspiratory muscle training; COPD; Dyspnea; Balance

Outcome Measures

Primary Outcomes (2)

• Dyspnea (Borg CR-10 scale)

  Dyspnea intensity perception on a 10-point Borg scale during constant work rate cycling exercise. Numerical value reported for intensity of dyspnea (shortness of breath) ranging from 0 (no symptoms) to 10 (maximal symptoms)

  Change from Baseline in Borg CR-10 scale at 8 weeks

• Center of pressure displacement

  Difference in center of pressure displacement on unstable support surface during a balance task after the intervention

  Change from Baseline in center of pressure at 8 weeks

Secondary Outcomes (16)

• Maximal inspiratory pressure (Pi,max)

  Change from Baseline in Pi,max at 8 weeks

• Inspiratory Muscle Endurance during a constant load breathing task

  Change from Baseline in endurance time at 8 weeks

• Endurance capacity during a constant load cycling exercise test

  Change from Baseline in endurance cycling time at 8 weeks

• Respiratory effort

  Change from Baseline in respiratory effort at 8 weeks

• Neural Respiratory Drive

  Change from Baseline in Neural Respiratory Drive at 8 weeks

Study Arms (2)

Inspiratory Muscle Strength Training

EXPERIMENTAL

High intensity inspiratory muscle training

Procedure: Inspiratory Muscle Strength Training

Inspiratory Muscle Endurance Training

SHAM COMPARATOR

Sham inspiratory muscle training at low intensity

Procedure: Inspiratory Muscle Endurance Training

Interventions

Inspiratory Muscle Strength Training PROCEDURE

IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The intervention group (strength IMT) will perform two daily sessions of 30 breaths. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain at least 40-50% of the actual Pi,max values. Each week, one training session will be performed under supervision. Training load will be increased during this session.

Also known as: Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UK

Inspiratory Muscle Strength Training

Inspiratory Muscle Endurance Training PROCEDURE

IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The sham group (endurance IMT) will perform three daily sessions of 30 breaths and will train at a constant inspiratory load of no more than 10% of their initial Pi,max. Each week, one training session will be performed under supervision.

Also known as: Electronic Variable Flow Resistive Loading IMT Device, POWERbreathe®KH1, HaB International Ltd., Southam, UK

Inspiratory Muscle Endurance Training

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical Diagnosis of COPD
• Inspiratory Muscle Weakness (Pi,max \<70% predicted or \< 60 cmH2O)
• Baseline dyspnea index (BDI) \< 7
• Peripheral muscle fatigue present after CPET

You may not qualify if:

• Major cardiovascular
• Limiting exercise capacity more than pulmonary function impairment
• Severe orthopedic with major impact on daily activities
• Psychiatric or cognitive disorders
• Progressive neurological or neuromuscular disorders
• Longterm O2 therapy

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

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

Study Officials

• Rik Gosselink, PhD

  Vicerector of Student Affairs KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: August 7, 2017
• Study Start: February 1, 2017
• Primary Completion: November 30, 2021
• Study Completion: January 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

BE (1)