Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Nurse Managed Upper Body Strength Training in COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01057797
• Other study ID #: NR08037
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2010
• Last updated: January 26, 2010
• Start date: September 2003
• Est. completion date: January 2009

Study information

• Verified date: January 2010
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Exercise-specific self-efficacy
Subjects in the experimental group will participate in a self-efficacy enhancing intervention designed to maximize (a) exercise-specific SE-UB strength training (b) self-efficacy for overcoming barriers to exercise and (c) SE-UB physical activities. The intervention incorporates strategies to maximize the primary sources of efficacy information: (a) mastery accomplishments, (b) social modeling, (c) social persuasion, (d) interpretation of physiological and affective symptoms.
• Gentle chair exercise
Gentle armchair fitness exercises will be used as a sham treatment to control for the attention that subjects receive in the two strength training groups. The armchair fitness exercises will be conducted in small groups (n=8-10 per group). Armchair exercises will include stretching of all major joints with an emphasis on the arms and shoulders, massage of muscles that can be reached from the armchair (scalp, neck, shoulders, lower back, abdomen and thighs) and imagery to promote relaxation. Each session will include: 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery for relaxation.
• upper body strength training
16 weeks of lab-based upper body strength training using 8: modified lateral pull down, shoulder shrug, upright row, overhead pull down, front raise, front pull down, triceps extension, biceps curl. Training load and volume will be increased progressing from 70% to 80% of the maximum strength training and from 2 sets of 8-10 repetitions progressing to 3 sets. Each week subjects will train twice in the lab and once at home. Home exercises will include 1 set of 15-20 repetitions: biceps curl, triceps extension, front raises, lateral raises, overhead press, chest press and one-arm dumbbell row.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper body strength		before training, after training, 6 months post training, 12 months post training	No
Primary	Dyspnea		before training, after training, 6 months post training, 12 months post training	No
Primary	Functional performance		before training, after training, 6 months post training, 12 months post training	No
Secondary	Exercise adherence		before training, after training	No