NCT01218295

Brief Summary

Many studies suggest that inspiratory muscles training by means of normocapnic hyperpnea improves exercise tolerance in healthy subjects. No information is available about the use of this training in COPD patients even if other methods (such as threshold loading and resistive loading) have been shown to be effective in terms of Inspiratory Muscle Function, Health-Related Quality of Life and Exercise Tolerance. This study is designed to evaluate the effects of normocapnic hyperventilation by means of Spirotiger®, an instrument training the respiratory muscles, avoiding hypocapnia (using the methodology of isocapnic hyperpnoea)in COPD patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

October 11, 2010

Status Verified

October 1, 2010

Enrollment Period

2.1 years

First QC Date

October 7, 2010

Last Update Submit

October 8, 2010

Conditions

Keywords

COPDinspiratory muscles training

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

    1 month

Study Arms (1)

Respiratory muscle training

EXPERIMENTAL

Patients assigned to this arm train the respiratory muscles by means of normocapnic hyperpnea.

Device: Spirotiger®

Interventions

training session :10 minutes twice a day X 4 weeks

Also known as: Pulmonary rehabilitation
Respiratory muscle training

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD patients. All patients are at stable state, free from an exacerbation from at least 3 months.

You may not qualify if:

  • COPD patients with a recent history of cardiovascular disease, neurologic disease and other diseases that would interfere with the training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pulmonary Respiratory Unit- University Hospital

Ferrara, Ferrara, 44100, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annalisa Cogo, MD

    Università di Ferrara

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Cogo, MD

CONTACT

Luca Pomidori, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 11, 2010

Study Start

May 1, 2009

Primary Completion

June 1, 2011

Study Completion

July 1, 2011

Last Updated

October 11, 2010

Record last verified: 2010-10

Locations