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Inspiratory Muscle Training Combined With General Exercise Training in COPD

Inspiratory Muscle Training Combined With General Exercise Training, Compared to General Exercise Training Alone in Patients With COPD: Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02392715
Acronym
IMTGET
Enrollment
80
Registered
2015-03-19
Start date
2015-04-30
Completion date
2016-12-31
Last updated
2015-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Inspiratory muscle training, General exercise training, pulmonary rehabilitation, chronic obstructive pulmonary disease

Brief summary

Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease, with increasing prevalence. Pulmonary rehabilitation through general exercise training (GET) is a corner stone of COPD care. Inspiratory muscle training (IMT) as a stand-alone therapy decreases dyspnea and improves exercise capacity. Whether IMT combined with GET adds a supplementary benefit in the rehabilitation of COPD patients is however uncertain.

Detailed description

Prospective, parallel-group, randomized controlled trial 80 COPD patients will be randomized into two groups. One group will receive general exercise training combined with inspiratory muscle training, 3 times a week, for a total of 36 sessions. The other group will receive general exercise training combined with shame inspiratory muscle training, 3 times a week, for a total of 36 sessions. We will assess the difference of improvement in exercise capacity between the 2 groups with the 6 minute walking test. We will also assess the difference of improvement in quality of life with St-George's respiratory questionnaire. Finally the difference of improvement in maximal inspiratory pressure will be determined. Patients and investigators assessing the outcomes will be blinded to group allocation. Written informed consent will be obtained from each subject. The data will be treated anonymously.

Interventions

DEVICEInspiratory muscle training with Threshold by respironics

Inspiratory muscle training 15 minutes, 3x/weeks, 36 sessions Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax.

with Threshold by respironics 15 minutes, 3x/weeks, 36 sessions Intensity: 5 centimeters of water (cmH20)

Sponsors

Hôpital Riviera-Chablais, Vaud-Valais
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* COPD demonstrated by spirometry using Gold Criteria * Patient referred by a pneumologist to the ambulatory pulmonary rehabilitation program at the Riviera-Chablais Hospital, Monthey * Patient with maximal inspiratory pressure \< 60 cmH20 * Patient older than 40 years

Exclusion criteria

* Orthopaedic or neurological troubles that could slant the 6 minute walking test

Design outcomes

Primary

MeasureTime frameDescription
Exercise capacity (six minute walking test)12 weeksexercise capacity will be assessed by a six minute walking test

Secondary

MeasureTime frameDescription
Quality of Life (St-George's Respiratory questionnaire)12 weeksQuality of Life will be assessed by St-George's Respiratory questionnaire
Maximal inspiratory pressure (MicroRPM by MicroMedical)12 weeksInspiratory maximal pressure will be assessed by the MicroRPM by MicroMedical

Contacts

Primary ContactStéphanie Vaudan, BSc
stephanie.vaudan@hopitalrivierachablais.ch+41 24 473 18 99
Backup ContactNicolas Garin, MD
nicolas.garin@hopitalrivierachablais.ch+ 41 24 473 80 75

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026