Chronic Obstructive Pulmonary DiseasePhase 2NCT01057797
Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Exercise-specific self-efficacy, Gentle chair exercise and upper body strength training in people with Chronic Obstructive Pulmonary Disease, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Exercise-specific self-efficacy, Gentle chair exercise and upper body strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Nurse Managed Upper Body Strength Training in COPD
This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Exercise-specific self-efficacy, Gentle chair exercise, upper body strength training
- Keywords
- COPD, Pulmonary rehabilitation, Self-efficacy, Muscle strength, Dyspnea, Exercise adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-specific self-efficacyBehavioural
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 exerciseBehavioural
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 trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Upper Body Strength Training with Self-Efficacy | Experimental | 16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention Receives: Behavioral: Exercise-specific self-efficacy; Behavioral: upper body strength training |
| Upper body strength training | Active comparator | 16 weeks of upper body strength training with weekly health education sessions Receives: Behavioral: upper body strength training |
| Chair exercise | Sham comparator | 16 wks of gentle chair exercise with weekly health education Receives: Behavioral: Gentle chair exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper body strength
Measured: before training, after training, 6 months post training, 12 months post training
Dyspnea
Measured: before training, after training, 6 months post training, 12 months post training
Functional performance
Measured: before training, after training, 6 months post training, 12 months post training
Secondary outcomes (1)
Exercise adherence
Measured: before training, after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startSep 2003
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Investigators
- Janet L Larson, PhD, RN, Principal investigator, University of Illinois at Chicago and University of MichiganMargaret K Covey, PhD, RN, Study director, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01057797
- Sponsor's protocol ID
- NR08037
- Status last verified
- Jan 2010
- First submitted
- 26 Jan 2010
- Last updated
- 27 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25336939
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Managed Upper Body Strength Training in COPD
- ClinicalTrials.gov ID
- NCT01057797
- Acronym / sponsor ID
- NR08037
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pulmonary rehabilitation, Self-efficacy, Muscle strength, Dyspnea, Exercise adherence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Upper Body Strength Training with Self-Efficacy | Experimental | Behavioral: Exercise-specific self-efficacy, Behavioral: upper body strength training16 weeks of upper body strength training combined with an exercise-specific self-efficacy enhancing intervention |
| Upper body strength training | Active comparator | Behavioral: upper body strength training16 weeks of upper body strength training with weekly health education sessions |
| Chair exercise | Sham comparator | Behavioral: Gentle chair exercise16 wks of gentle chair exercise with weekly health education |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-specific self-efficacySubjects 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. | Behavioural | Upper Body Strength Training with Self-Efficacy |
| Gentle chair exerciseGentle 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. | Behavioural | Chair exercise |
| upper body strength training16 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. | Behavioural | Upper Body Strength Training with Self-Efficacy, Upper body strength training |
Primary outcome
Upper body strength
Time frame: before training, after training, 6 months post training, 12 months post training
Dyspnea
Time frame: before training, after training, 6 months post training, 12 months post training
Functional performance
Time frame: before training, after training, 6 months post training, 12 months post training
1 secondary outcome
Exercise adherence
Time frame: before training, after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2010.
- Derived from this study: PubMed 25336939Larson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet L Larson, PhD, RN principal investigator
University of Illinois at Chicago and University of Michigan
Margaret K Covey, PhD, RN study director
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise-specific self-efficacy, Gentle chair exercise and upper body strength training in people with Chronic Obstructive Pulmonary Disease, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper body strength (time frame: before training, after training, 6 months post training, 12 months post training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01057797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2010.