- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935181
Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)
July 7, 2009 updated by: Faculdade Evangelica do Parana
Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program
Objective: The investigators studied the effects of respiratory muscle stretching in an 8-week pulmonary rehabilitation program.
Methods: This was a simple-blind parallel controlled trial, conducted an out-patient clinic.
Twenty six patients with COPD (mean age 68 ± 6 y, percent of predicted FEV1 47 ± 16) were randomized to either respiratory muscle stretching group plus exercise training (RMS), and exercise training group (Sham), in an 8-week exercise program that had 3 sessions per week.
The investigators measured inspiratory and expiratory muscle strength (by maximal inspiratory and expiratory pressure - PIM and PEM), exercise capacity (by 6-minute walk distance), dyspnea and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paraná
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Curitiba, Paraná, Brazil, 80730-000
- Faculdade Evangélica do Paraná
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects between 40 and 75 years of age referred by a physician to the Pulmonary Rehabilitation Program
- With a clinical and spirometric diagnosis of moderate to severe COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD), in a stable condition (without exacerbations or infections for at least a month)
- Former smokers
Exclusion Criteria:
- Patients with a known history of asthma, or severe and/or unstable heart disease
- Any other pathological condition that could impair their physical activities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: exercise training program
The exercise training program consisted of three 90-minute sessions per week for eight weeks.
Each session consisted of a stretching exercise, resistance that patients started at 70% of the initial one-repetition maximum (1RM: the maximum load which can be moved only once over the full range of motion without compensatory movements) in the first week (3x8 repetitions).
Every week the load was increased by 5% of the 1RM, and endurance training (treadmill walking speed was set at 60% of the average speed obtained from the 6MWT (6MWTpeak) for 10 mins in the first week and was increased to 20 mins in week 8
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stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inspiratory muscle strength
Time Frame: 2 hours
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2 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exercise capacity
Time Frame: 2 hours
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2 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Silvia R. Valderramas, Ph.D, Faculdade Evangélica do Paraná
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (ACTUAL)
December 1, 2006
Study Completion (ACTUAL)
December 1, 2008
Study Registration Dates
First Submitted
June 29, 2009
First Submitted That Met QC Criteria
July 7, 2009
First Posted (ESTIMATE)
July 8, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
July 8, 2009
Last Update Submitted That Met QC Criteria
July 7, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3145/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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