Inspiratory Muscle Training on Respiratory Muscle Function，Quality of Life and Exercise Capacity in Stable COPD

NCT03101774 | Completed

• 1 other identifier: GuangzhouInsRD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparable RCTs of clinical therapeutic effects using respiratory physiology-oriented IMT device in different operation principle in COPD are so far lacking. Therefore the investigators perform an adequately powered RCT on the effects of two IMT device application as an pulmonary physical therapy in patients with COPD with inspiratory muscle weakness.

Conditions

COPD

Keywords

inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Respiratory muscle force

  Maximal inspiratory pressure measurement is a test of inspiratory muscle force. The measurement of maximal inspiratory pressure reflects the strength generated by the entire inspiratory muscles. Patients were normally seated and strongly urged to make maximum inspiratory efforts at residual volume(RV). The maximum pressure value of mouthpiece was measured during the maximal inspiratory maneuvers. The maximum value of three satisfactory manipulation that vary by less than 20% was recorded. Unit of maximal inspiratory pressure measurement is cmH2O (centimeter water column) as a pressure unit.

  8 weeks

Secondary Outcomes (4)

• Health-related quality of life

  8 weeks

• degree of dyspnea

  8 weeks

• blood gas analysis

  8 weeks

• Maximal exercise capacity (incremental cardiopulmonary exercise testing)

  8 weeks

Study Arms (3)

threshold-IMT group

EXPERIMENTAL

Using inspiratory muscle training using threshold load device for 8 weeks

Device: Threshold inspiratory muscle training

resisive-IMT group

EXPERIMENTAL

Using inspiratory muscle training using resistive device for 8 weeks

Device: Resistive inspiratory muscle training

control group

SHAM COMPARATOR

not conduct inspiratory muscle training for 8 weeks

Other: Control group

Interventions

Threshold inspiratory muscle training DEVICE

Threshold inspiratory muscle training device (Threshold Inspiration Muscle Trainer, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.

threshold-IMT group

Resistive inspiratory muscle training DEVICE

Resistive inspiratory muscle training device(PFLEX, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.

resisive-IMT group

Control group OTHER

Conventional therapy without any inspiratory muscle training program

control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group);
• Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）;
• Bronchial dilation test (BDT) negative;
• No history of pulmonary rehabilitation.

You may not qualify if:

• severe orthopaedic problems having a major impact on daily activities;
• diagnosed psychiatric or cognitive disorders
• progressive neurological or neuromuscular disorders.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rongchang Chen, Prof

  Guangzhou Institute of Respiratory Disease

  STUDY CHAIR

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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: April 5, 2017
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 5, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share