NCT01057797

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
Last Updated

January 27, 2010

Status Verified

January 1, 2010

Enrollment Period

5.3 years

First QC Date

January 26, 2010

Last Update Submit

January 26, 2010

Conditions

Keywords

COPDPulmonary rehabilitationSelf-efficacyMuscle strengthDyspneaExercise adherence

Outcome Measures

Primary Outcomes (3)

  • Upper body strength

    before training, after training, 6 months post training, 12 months post training

  • Dyspnea

    before training, after training, 6 months post training, 12 months post training

  • Functional performance

    before training, after training, 6 months post training, 12 months post training

Secondary Outcomes (1)

  • Exercise adherence

    before training, after training

Study Arms (3)

Upper Body Strength Training with Self-Efficacy

EXPERIMENTAL

16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention

Behavioral: Exercise-specific self-efficacyBehavioral: upper body strength training

Upper body strength training

ACTIVE COMPARATOR

16 weeks of upper body strength training with weekly health education sessions

Behavioral: upper body strength training

Chair exercise

SHAM COMPARATOR

16 wks of gentle chair exercise with weekly health education

Behavioral: Gentle chair exercise

Interventions

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.

Upper Body Strength Training with Self-Efficacy

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.

Chair exercise

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.

Upper Body Strength Training with Self-EfficacyUpper body strength training

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Janet L Larson, PhD, RN

    University of Illinois at Chicago and University of Michigan

    PRINCIPAL INVESTIGATOR
  • Margaret K Covey, PhD, RN

    University of Illinois at Chicago

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

September 1, 2003

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

January 27, 2010

Record last verified: 2010-01

Locations