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Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00935181
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 8, 2009
Sponsor:
Information provided by:
Faculdade Evangelica do Parana

Tracking Information
First Submitted Date  ICMJE June 29, 2009
First Posted Date  ICMJE July 8, 2009
Last Update Posted Date July 8, 2009
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Inspiratory muscle strength [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2009)
Exercise capacity [ Time Frame: 2 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Respiratory Muscle Stretching in Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE Respiratory Muscle Stretching in Patients With Chronic Obstructive Pulmonary Disease Submitted a Pulmonary Rehabilitation Program
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Behavioral: respiratory muscle stretching
stretching exercises for respiratory muscles like diaphragm, pectoral, dorsalis etc
Other Name: pulmonary rehabilitation
Study Arms  ICMJE 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
Intervention: Behavioral: respiratory muscle stretching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2009)
26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00935181
Other Study ID Numbers  ICMJE 3145/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Silvia Regina Valderramas, Faculdade Evangelica do Paraná
Study Sponsor  ICMJE Faculdade Evangelica do Parana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia R. Valderramas, Ph.D Faculdade Evangelica do Paraná
PRS Account Faculdade Evangelica do Parana
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP