Effects of Inspiratory Muscle Training on Shortness of Breath (Dyspnea) and Postural Control in Patients With COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KU Leuven
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Center of pressure displacement
Study Overview
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.
Detailed Description
The purpose of this clinical trial is to elucidate mechanisms of dyspnea relief and improvements in postural control after inspiratory muscle training (IMT) in patients with COPD.
An endurance cycle exercise test (Constant work rate (CWR) test) will be used to evaluate dyspnea intensity and unpleasantness at comparable breathing efforts, at comparable work rates on the cycle ergometer, before and after IMT. Patients will be performing a CWR test at 75% of the peak work rate achieved during a maximal incremental cardiopulmonary exercise test (CPET). Before, during and after CWR cycling tests patients will rate their intensity of dyspnea, unpleasantness of dyspnea, breathing related-anxiety and leg discomfort using a modified 10- point Borg scale. Patients will be asked to report qualitative descriptors of dyspnea at the end of the CWR cycling test. Maximum duration of the CWR test will be recorded and levels of minute ventilation will be registered continuously throughout the exercise protocol. With this endurance exercise test the investigators will be able to assess changes in the onset of dyspnea (intensity and unpleasantness) and the performance in endurance exercise before and after IMT.
Surface electromyography (EMG), and a multipair esophageal electrode catheter system will be used during CWR exercise to evaluate respiratory muscle recruitment, respiratory effort and neural drive to the different respiratory muscles. The catheter will be inserted to continuously record Pes (esophageal pressure), Pgas (gastric pressure) and EMGdi (electromyogram of the diaphragm muscle). PesMax (maximal esophageal pressure), PgasMax (maximal gastric pressure) and PdiMax (maximal transdiaphragmatic pressure) will be obtained during maximal sniff and cough maneuvers. Transcutaneous surface electromyography (sEMG) techniques will be applied to scalene, sternocleidomastoid and parasternal intercostal muscles to register neural drive to these respiratory muscles. With this measurements, the investigators will be able to assess whether there are any changes in respiratory muscle recruitment patterns and respiratory neural drive to the different respiratory muscles after IMT.
During exercise 'Respiratory Muscle Metaboreflex' will lead to sympathetically mediated vasoconstriction of limb locomotor muscle, less blood and oxygen supply to active limbs muscle there by locomotor muscle fatigue occurred. Quadriceps twitch forces evoked by magnetic stimulation of femoral nerve will be assessed to measure locomotor muscle fatigue at identical exercise time points during CWR test before and after the intervention. With this technique, the investigators will be able to assess whether the onset of locomotor muscle fatigue is delayed after IMT.
An isocapnic hyperpnea trial will be performed to assess respiratory muscle perfusion, dyspnea intensity and unpleasantness, respiratory muscle recruitment pattern, respiratory effort and neural respiratory drive without the work of locomotor muscle before and after IMT. Patients will be asked to maintain a targeted minute ventilation pattern equal to their breathing frequency, tidal volume and minute ventilation recorded at rest and during the final minute of constant load exercise test (at ~75% WRpeak). Experimenters will provide verbal guidance to patients to adjust the rate and depth of their breathing such that the target ventilation will be obtained and maintained constant within ±5%. Isocapnia will be maintained by having subjects inspire from a Douglas bag containing 5% CO2, 21% O2, balance N2 that will be connected to a two-way non-rebreathing valve (model 2700, Hans Rudolph) by a piece of tubing.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •Previous inclusion in rehabilitation program (<1 year)
Arms & Interventions
Inspiratory Muscle Strength Training
High intensity inspiratory muscle training
Intervention: Inspiratory Muscle Strength Training (Procedure)
Inspiratory Muscle Endurance Training
Sham inspiratory muscle training at low intensity
Intervention: Inspiratory Muscle Endurance Training (Procedure)
Outcomes
Primary Outcomes
Center of pressure displacement
Time Frame: Change from Baseline in center of pressure at 8 weeks
Difference in center of pressure displacement on unstable support surface during a balance task after the intervention
Dyspnea (Borg CR-10 scale)
Time Frame: Change from Baseline in Borg CR-10 scale at 8 weeks
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)
Secondary Outcomes
- 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)
- Daily Physical Activity(Change in daily steps and time in moderate to vigorous daily physical activity from Baseline at 8 weeks)
- Locomotor muscle fatigue (Quadriceps twitch forces)(Change from Baseline in quadriceps twitch forces at 8 weeks)
- Respiratory and locomotor muscle perfusion(Change from Baseline in respiratory and locomotor muscle blood flow at 8 weeks)
- Pulmonary Function(Change from Baseline in Pulmonary Function parameters at 8 weeks)
- Dyspnea intensity (Borg CR-10 scale)(Change from Baseline in Borg CR-10 scale at 8 weeks)
- Dyspnea unpleasantness (Borg CR-10 scale)(Change from Baseline in Borg CR-10 scale at 8 weeks)
- Inspiratory Muscle Endurance during a constant load breathing task(Change from Baseline in endurance time at 8 weeks)
- Neural Respiratory Drive(Change from Baseline in Neural Respiratory Drive at 8 weeks)
- Maximal inspiratory pressure (Pi,max)(Change from Baseline in Pi,max at 8 weeks)
- Ventilatory Muscle Recruitment (VMR)(Change from Baseline in Ventilatory Muscle Recruitment at 8 weeks)
- Respiratory-related evoked potential (RREPs)(Change from Baseline in RREPs at 8 weeks)
- Evoked potential elicited by the geometric figures(Change from Baseline in Evoked potential at 8 weeks)
- Stress level(Change from Baseline in stress level at 8 weeks)
- Salivary cortisol levels(Change from Baseline in salivary cortisol levels at 8 weeks)
Investigators
Daniel Langer
Principal Investigator
KU Leuven
