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

This study has been completed.
Sponsor:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01057797
First received: January 26, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Behavioral: Exercise-specific self-efficacy
Behavioral: Gentle chair exercise
Behavioral: upper body strength training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Nurse Managed Upper Body Strength Training in COPD

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Upper body strength [ Time Frame: before training, after training, 6 months post training, 12 months post training ] [ Designated as safety issue: No ]
  • Dyspnea [ Time Frame: before training, after training, 6 months post training, 12 months post training ] [ Designated as safety issue: No ]
  • Functional performance [ Time Frame: before training, after training, 6 months post training, 12 months post training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise adherence [ Time Frame: before training, after training ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: September 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Upper Body Strength Training with Self-Efficacy
16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing 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.
Behavioral: 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.
Active Comparator: Upper body strength training
16 weeks of upper body strength training with weekly health education sessions
Behavioral: 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.
Sham Comparator: Chair exercise
16 wks of gentle chair exercise with weekly health education
Behavioral: 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.

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

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01057797

Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Janet L Larson, PhD, RN University of Illinois at Chicago and University of Michigan
Study Director: Margaret K Covey, PhD, RN University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Janet L. Larson, PhD, RN, University of Illinois at Chicago and University of Michigan
ClinicalTrials.gov Identifier: NCT01057797     History of Changes
Other Study ID Numbers: NR08037
Study First Received: January 26, 2010
Last Updated: January 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
COPD
Pulmonary rehabilitation
Self-efficacy
Muscle strength
Dyspnea
Exercise adherence

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014