Effects of Inspiratory Muscle Training on Dyspnea Perception During Exercise in Patients With COPD

NCT01900873 | Completed DMC

• 1 other identifier: DMED-1579-13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic obstructive pulmonary disease are often limited in their exercise capacity by intolerable shortness of breath (dyspnea). Patients are breathing at high lung volumes during exercise which forces inspiratory muscles to work at a high percentage of their maximal capacity. This increased inspiratory effort has been shown to be independently related to symptoms of dyspnea during exercise in previous research. Eight weeks of high intensity variable flow resistive inspiratory muscle training is hypothesized to reduce inspiratory effort and to decrease neural drive to inspiratory muscles. These factors are hypothesized to jointly contribute to delaying the occurrence of intolerable symptoms of dyspnea and to improve exercise tolerance in these patients.

Conditions

COPD; Severe Systemic Illness-induced Respiratory Muscle Wasting

Keywords

Inspiratory Muscle Training; COPD; Inspiratory Muscle Function; Dyspnea

Outcome Measures

Primary Outcomes (1)

• Dyspnea (Borg CR-10 scale)

  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

Secondary Outcomes (6)

• 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 time at 8 weeks

• Pulmonary Function

  Change from Baseline in Pulmonary Function parameters at 8 weeks

• Daily Physical Activity

  Change in daily steps and time in moderate to vigorous daily physical activity from Baseline at 8 weeks

Study Arms (2)

Inspiratory Muscle Strength Training

EXPERIMENTAL

High intensity inspiratory muscle training

Device: Inspiratory Muscle Strength Training

Inspiratory Muscle Endurance Training

SHAM COMPARATOR

Sham inspiratory muscle training at low intensity

Device: Inspiratory Muscle Endurance Training

Interventions

Inspiratory Muscle Strength Training DEVICE

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 DEVICE

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 \< 70cmH2O or \< 70% predicted)

You may not qualify if:

• Major cardiovascular, orthopedic, or cognitive impairments limiting exercise capacity more than pulmonary function impairment.

Sponsors & Collaborators

• KU Leuven: lead
• Queen's University, Kingston, Ontario: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, Canada

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

• Daniel Langer

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Research Fellow Research Foundation Flanders

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 17, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

CA (1)