Effects of Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease (COPD)

NCT01903772 | Completed DMC

• 2 other identifiers: IMTCOSchön Klinik BGL
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with COPD with inspiratory muscle weakness will be studied. The main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.

Conditions

COPD; Inspiratory Muscle Weakness

Outcome Measures

Primary Outcomes (1)

• 6-Minute walking distance

  change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

Secondary Outcomes (4)

• exercise capacity (constant work rate test)

  change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

• maximal inspiratory pressure (PImax)

  change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

• inspiratory muscle endurance capacity

  change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

• dyspnea

  change from the beginning at 3 weeks of a inpatient pulmonary rehabilitation program

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Procedure: Inspiratory Muscle Training Three times daily inspiratory muscle training (2x30 breaths) at an intensity of \>50% Pi,max

Other: Inspiratory Muscle Training

Sham Inspiratory Muscle Training

SHAM COMPARATOR

Twice daily inspiratory muscle training (3x30 breaths) at an intensity of 5 centimeters of water (H2O)

Other: Inspiratory Muscle Training

Interventions

Inspiratory Muscle Training OTHER

Inspiratory Muscle Training; Sham Inspiratory Muscle 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:

• Patients with COPD
• Eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks
• Pi,max \<60 centimeters of water or \<50% of the predicted normal value

You may not qualify if:

• Major comorbidities preventing successful participation in an 8 week exercise training intervention
• use of non-invasive ventilation

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• KU Leuven: collaborator

Study Sites (1)

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Bavaria, 83483, Germany

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 19, 2013
• Study Start: April 1, 2013
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 3, 2017

Record last verified: 2017-03

Locations

DE (1)