Clinical trial NCT01057797: Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Nurse Managed Upper Body Strength Training in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Pulmonary rehabilitation
Self-efficacy
Muscle strength
Dyspnea
Exercise adherence
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2010-01-27
Enrollment: 208
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.

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.

Eligibility criteria: Inclusion Criteria:

* FEV1/FVC \< 70 and FEV1 \< 80%
* \> or = 45 years of age
* Currently in stable clinical condition \[free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy\]
* Taking appropriate medications according to the GOLD standards
* Experience dyspnea with the use of their arms.

Exclusion Criteria:

* Evidence of restrictive lung disease or asthma
* Acute respiratory infection
* Taking oral corticosteroids on a regular basis
* \>3 exacerbations in the previous year
* Evidence of significant depression (Hospital Anxiety Depression Scale \>10)
* Presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis, evidence of alcohol or drug abuse, diabetes requiring insulin therapy, musculoskeletal or degenerative nerve disease, etc.
* Presence of a condition that would make it potentially unsafe to exercise, including a history of a recent myocardial infarction, unstable angina pectoris, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, severe symptomatic aortic stenosis, uncontrolled symptomatic heart failure, uncontrolled metabolic disease, abnormal response to exercise test
* Currently participating in pulmonary rehabilitation.

Primary outcomes:
measure: Upper body strength
timeFrame: before training, after training, 6 months post training, 12 months post training
measure: Dyspnea
timeFrame: before training, after training, 6 months post training, 12 months post training
measure: Functional performance
timeFrame: before training, after training, 6 months post training, 12 months post training
Secondary outcomes:
measure: Exercise adherence
timeFrame: before training, after training
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago and University of Michigan
name: Janet L Larson, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Illinois at Chicago
name: Margaret K Covey, PhD, RN
role: STUDY_DIRECTOR
References:
citation: Larson JL, Covey MK, Kapella MC, Alex CG, McAuley E. Self-efficacy enhancing intervention increases light physical activity in people with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2014 Oct 3;9:1081-90. doi: 10.2147/COPD.S66846. eCollection 2014.