Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
Tracking Information | |||||||||
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First Received Date ICMJE | January 26, 2010 | ||||||||
Last Updated Date | January 26, 2010 | ||||||||
Start Date ICMJE | September 2003 | ||||||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
Exercise adherence [ Time Frame: before training, after training ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD) | ||||||||
Official Title ICMJE | Nurse Managed Upper Body Strength Training in COPD | ||||||||
Brief Summary | This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up. |
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Detailed Description | People with moderate to severe chronic obstructive pulmonary disease (COPD) experience intense symptoms of dyspnea when they use their arms and shoulders. To control dyspnea they avoid using their arms and ultimately experience a significant loss of upper body (UB) strength and a decrease in the level of physical activity. Some pulmonary rehabilitation programs include strength training, but the training intensity is typically very low. The purpose of this research is to examine the effects of UB strength training (designed to maximize strength gains) with a self-confidence intervention to enhance adherence to exercise. This is an experimental study with random assignment of subjects to one experimental and two control groups: (a) UB strength training and self-efficacy intervention for adherence (experimental), (b) UB strength training with health education (control 1) and (c) gentle armchair fitness exercises with health education (control 2). Each subject will be studied for a total of 16 months.The intervention period is four months in duration with a 12-month follow-up period. The sample will be people with moderate to severe COPD who experience dyspnea with UB activities. This research is innovative in that it examines the effects of upper body strength training designed to maximize strength gains and combines it with a theory-based self-efficacy (confidence-building) intervention to promote adherence to training in people with COPD. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | 208 | ||||||||
Completion Date | January 2009 | ||||||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 45 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01057797 | ||||||||
Other Study ID Numbers ICMJE | NR08037 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Janet L. Larson, PhD, RN, University of Illinois at Chicago and University of Michigan | ||||||||
Study Sponsor ICMJE | University of Illinois | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | University of Illinois | ||||||||
Verification Date | January 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |