NCT00952718

Brief Summary

The purpose of this study is to determine whether inspiratory muscle training could improve and/or prevent the deterioration of inspiratory muscle strength, clinical cardiopulmonary outcome, systemic immunologic responses and quality of life in patients with bronchiectasis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
10.2 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

July 28, 2021

Status Verified

July 1, 2021

Enrollment Period

11 months

First QC Date

August 3, 2009

Results QC Date

August 12, 2019

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum Inspiratory Pressure (MIP) and Maximum Expiratory Pressure (MEP) at 8 Weeks

    MEP was measured after maximal inspiration,while MIP was measured after maximal expiration with each subject seated and wearing a nose-clip. An experienced respiratory therapist strongly urged the subjects to make maximum inspiratory and expiratory efforts at or near residual and total lung capacity, respectively. Determinations were repeated until two technically satisfactory measurements were recorded, with the highest value used for calculations.

    baseline and 8 weeks

Secondary Outcomes (2)

  • Six Minutes Walking Distance

    baseline and 8 weeks

  • 6 Minute Work

    baseline and 8 weeks

Study Arms (2)

Control

NO INTERVENTION

No intervention.

Inspiratory muscle training

EXPERIMENTAL

With intervention.

Other: Inspiratory muscle training

Interventions

A pressure threshold device (Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA) was used for the inspiratory muscle training program. The individualized training program was started at an intensity of 30% MIP, which was increased by 2 cmH2O each week, but the maximal intensity did not exceed 50% of MIP. Patients were encouraged to perform IMT for 30 minutes per day, at least 5 days a week for 8 weeks.

Also known as: Pulmonary Rehabilitation
Inspiratory muscle training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bronchiectasis confirmed by clinical history, pulmonary function test, and high resolution computed tomography

You may not qualify if:

  • Had recent exacerbation within six weeks
  • Use of corticosteroid
  • With poor consciousness level
  • Have cerebro-vascular or neuro-muscular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital-Kaohsiung Medical Center

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. Liaw MY
Organization
ChangGungMH

Study Officials

  • Meng-Chih Lin, MD

    Chang Gung Memorial Hospital-Kaohsiung Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 6, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

July 28, 2021

Results First Posted

October 21, 2019

Record last verified: 2021-07

Locations