Back to results

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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Exercise-specific self-efficacy

Gentle chair exercise

upper body strength training

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Pulmonary rehabilitation, Self-efficacy, Muscle strength, Dyspnea, Exercise adherence

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Upper Body Strength Training with Self-Efficacy

Upper body strength training

Chair exercise

Arm Description

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

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

16 wks of gentle chair exercise with weekly health education

Outcomes

Primary Outcome Measures

Upper body strength

Dyspnea

Functional performance

Secondary Outcome Measures

Exercise adherence

Full Information

NCT ID

NCT01057797

First Posted

January 26, 2010

Last Updated

January 26, 2010

Sponsor

University of Illinois at Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01057797

Brief Title

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

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Illinois at Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD, Pulmonary rehabilitation, Self-efficacy, Muscle strength, Dyspnea, Exercise adherence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

208 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Upper Body Strength Training with Self-Efficacy

Arm Type

Experimental

Arm Description

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

Arm Title

Upper body strength training

Arm Type

Active Comparator

Arm Description

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

Arm Title

Chair exercise

Arm Type

Sham Comparator

Arm Description

16 wks of gentle chair exercise with weekly health education

Intervention Type

Behavioral

Intervention Name(s)

Exercise-specific self-efficacy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Gentle chair exercise

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

upper body strength training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Upper body strength

Time Frame

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

Title

Dyspnea

Time Frame

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

Title

Functional performance

Time Frame

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

Secondary Outcome Measure Information:

Title

Exercise adherence

Time Frame

before training, after training

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet L Larson, PhD, RN

Organizational Affiliation

University of Illinois at Chicago and University of Michigan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Margaret K Covey, PhD, RN

Organizational Affiliation

University of Illinois at Chicago

Official's Role

Study Director

Facility Information:

Facility Name

University of Illinois at Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25336939

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs