Pulmonary Disease, Chronic ObstructivePhase 3NCT00328484
Comparison of Two Programs to Encourage Physical Activity in Individuals With Chronic Obstructive Pulmonary Disease
A Phase 3 study testing Lifestyle Activity Program and Exercise Program in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical activity may relieve the symptoms of COPD and may also slow the progression of the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive
- What is being tested?
- Lifestyle Activity Program and Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jul 2007
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Expiratory airflow limitation such that FEV1/FVC is less than or equal to 70% and the FEV₁ is greater than or equal to 20% of the predicted amount
- Physical disability, including self-reported difficulty with walking a city block, climbing stairs, lifting and carrying groceries, performing household activities such as cleaning and doing yard work, or getting out of a chair
- Currently lives within a 35-mile radius of Wake Forest University
- Plans to reside in Forsyth County, North Carolina for the entire study
- Willing and able to participate in all aspects of the trial
Who cannot join
- Undergoing treatment for cancer
- Severe congestive heart failure
- Stroke
- Peripheral vascular disease
- Coronary artery disease
- Valvular heart disease
Show all 15Show fewer
- Major psychiatric disease
- Severe anemia
- Liver or kidney disease
- Uncontrolled diabetes or hypertension
- Orthopedic impairment
- Blindness or deafness
- Oxygen desaturation during exercise to less than 90%, at a heart rate less than 50% of predicted maximum for participant's age and without supplemental oxygen
- Inability to exercise due to a physical disability or positive exercise stress test
- Alcohol consumption of greater than two drinks per day in the 2 months prior to study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University
Winston-Salem, North Carolina, 27109
About this study
Official title: Exercise and Disability in COPD Patients
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical activity may relieve the symptoms of COPD and may also slow the progression of the disease. The purpose of this study is to evaluate the effectiveness of a lifestyle activity program versus a traditional exercise program at increasing the amount of physical activity among individuals with COPD.
Read the detailed description
COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. It is the fourth leading cause of death in the United States. Cigarette smoking is the most common cause of COPD; however, breathing in other types of lung irritants, including pollution, dust, and chemicals, over a long period of time may also cause or contribute to COPD. The primary symptoms of COPD, exercise intolerance and shortness of breath, often result in physical activity limitations, which may lead to a decreased quality of life. While COPD is a chronic, incurable disease, individuals who incorporate exercise and physical activity into their daily lifestyle may reduce the symptoms and slow the progression of the disease. The purpose of this study is to compare the effectiveness of an overall lifestyle activity program versus a traditional exercise program on physical activity in individuals with COPD. The study will also evaluate the impact of the two programs on exercise capacity, physical function, self-reported disability, and health-related quality of life.
Participants with COPD will be randomly assigned to either an 11-month lifestyle activity program or a traditional 3-month exercise program. The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support. The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
All participants will attend 4 baseline study visits at which their medical history will be reviewed and standardized questionnaires will be completed to assess mood, depression, social factors, COPD symptoms, and physical activity levels. Participants will undergo a physical examination; a blood draw for laboratory testing; and spirometry, lung function, exercise, and strength tests. These measures will be assessed again at 3, 6, and 12 months; the 3- and 12-month assessments will occur over four study visits, and the 6-month assessment will occur over two study visits.
- Being tested
- Lifestyle Activity Program, Exercise Program
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Exercise, Emphysema, Chronic Bronchitis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Motor Activity, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Activity ProgramBehavioural
The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support.
Exercise ProgramBehavioural
The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Eleven month lifestyle activity program Receives: Behavioral: Lifestyle Activity Program |
| 2 | Active comparator | Three month exercise program Receives: Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of time engaged in moderate physical activity each week
Measured: Measured at Year 1
Secondary outcomes (4)
Health related quality of life
Measured: Measured at Year 1
Self-reported disability
Measured: Measured at Year 1
Physical function
Measured: Measured at Year 1
Exercise capacity
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startJan 2002
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael J. Berry, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328484
- Sponsor's protocol ID
- 387
- Other IDs
- R01HL053755-09
- Status last verified
- Feb 2009
- First submitted
- 19 May 2006
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Foy CG, Wickley KL, Adair N, Lang W, Miller ME, Rejeski WJ, Woodard CM, Berry MJ. The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease. Contemp Clin Trials. 2006 Apr;27(2):135-46. doi: 10.1016/j.cct.2005.11.011. Epub 2006 Feb 2.
PubMed 16458075Katula JA, Rejeski WJ, Wickley KL, Berry MJ. Perceived difficulty, importance, and satisfaction with physical function in COPD patients. Health Qual Life Outcomes. 2004 Mar 31;2:18. doi: 10.1186/1477-7525-2-18.
PubMed 15056389Berry MJ, Adair NE, Rejeski WJ. Use of peak oxygen consumption in predicting physical function and quality of life in COPD patients. Chest. 2006 Jun;129(6):1516-22. doi: 10.1378/chest.129.6.1516.
PubMed 16778269Berry MJ, Rejeski WJ, Miller ME, Adair NE, Lang W, Foy CG, Katula JA. A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Respir Med. 2010 Jun;104(6):829-39. doi: 10.1016/j.rmed.2010.02.015. Epub 2010 Mar 26.
PubMed 20347286
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Disability in COPD Patients
- ClinicalTrials.gov ID
- NCT00328484
- Acronym / sponsor ID
- 387
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Exercise, Emphysema, Chronic Bronchitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 22 May 2006 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease. Symptoms include shortness of breath, wheezing, and difficulty exercising. Increasing exercise and physical activity may relieve the symptoms of COPD and may also slow the progression of the disease. The purpose of this study is to evaluate the effectiveness of a lifestyle activity program versus a traditional exercise program at increasing the amount of physical activity among individuals with COPD.
Detailed description
COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. It is the fourth leading cause of death in the United States. Cigarette smoking is the most common cause of COPD; however, breathing in other types of lung irritants, including pollution, dust, and chemicals, over a long period of time may also cause or contribute to COPD. The primary symptoms of COPD, exercise intolerance and shortness of breath, often result in physical activity limitations, which may lead to a decreased quality of life. While COPD is a chronic, incurable disease, individuals who incorporate exercise and physical activity into their daily lifestyle may reduce the symptoms and slow the progression of the disease. The purpose of this study is to compare the effectiveness of an overall lifestyle activity program versus a traditional exercise program on physical activity in individuals with COPD. The study will also evaluate the impact of the two programs on exercise capacity, physical function, self-reported disability, and health-related quality of life.
Participants with COPD will be randomly assigned to either an 11-month lifestyle activity program or a traditional 3-month exercise program. The lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support. The 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks.
All participants will attend 4 baseline study visits at which their medical history will be reviewed and standardized questionnaires will be completed to assess mood, depression, social factors, COPD symptoms, and physical activity levels. Participants will undergo a physical examination; a blood draw for laboratory testing; and spirometry, lung function, exercise, and strength tests. These measures will be assessed again at 3, 6, and 12 months; the 3- and 12-month assessments will occur over four study visits, and the 6-month assessment will occur over two study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle Activity ProgramEleven month lifestyle activity program |
| 2 | Active comparator | Behavioral: Exercise ProgramThree month exercise program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Expiratory airflow limitation such that FEV1/FVC is less than or equal to 70% and the FEV₁ is greater than or equal to 20% of the predicted amount
- Physical disability, including self-reported difficulty with walking a city block, climbing stairs, lifting and carrying groceries, performing household activities such as cleaning and doing yard work, or getting out of a chair
- Currently lives within a 35-mile radius of Wake Forest University
- Plans to reside in Forsyth County, North Carolina for the entire study
- Willing and able to participate in all aspects of the trial
Key exclusion criteria (15 listed)
- Undergoing treatment for cancer
- Severe congestive heart failure
- Stroke
- Peripheral vascular disease
- Coronary artery disease
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 |
|---|---|---|
| Lifestyle Activity ProgramThe lifestyle activity program will consist of 35 exercise and counseling sessions spaced over 11 months. This program will use cognitive-behavioral strategies to encourage physical activity at home. Participants will receive information on how to deal with COPD symptoms (including shortness of breath), goal-setting, social support, and motivation. Participants will also receive follow-up telephone calls from the program staff for additional support. | Behavioural | 1 |
| Exercise ProgramThe 3-month exercise program will consist of 36 1-hour exercise training sessions, conducted 3 times a week for 12 weeks. | Behavioural | 2 |
Primary outcome
Amount of time engaged in moderate physical activity each week
Time frame: Measured at Year 1
4 secondary outcomes
Health related quality of life
Time frame: Measured at Year 1
Self-reported disability
Time frame: Measured at Year 1
Physical function
Time frame: Measured at Year 1
Exercise capacity
Time frame: Measured at Year 1
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 29 Jul 2016.
- Background: PubMed 16458075Foy CG, Wickley KL, Adair N, Lang W, Miller ME, Rejeski WJ, Woodard CM, Berry MJ. The Reconditioning Exercise and Chronic Obstructive Pulmonary Disease Trial II (REACT II): rationale and study design for a clinical trial of physical activity among individuals with chronic obstructive pulmonary disease. Contemp Clin Trials. 2006 Apr;27(2):135-46. doi: 10.1016/j.cct.2005.11.011. Epub 2006 Feb 2.
- Background: PubMed 15056389Katula JA, Rejeski WJ, Wickley KL, Berry MJ. Perceived difficulty, importance, and satisfaction with physical function in COPD patients. Health Qual Life Outcomes. 2004 Mar 31;2:18. doi: 10.1186/1477-7525-2-18.
- Background: PubMed 16778269Berry MJ, Adair NE, Rejeski WJ. Use of peak oxygen consumption in predicting physical function and quality of life in COPD patients. Chest. 2006 Jun;129(6):1516-22. doi: 10.1378/chest.129.6.1516.
- Derived from this study: PubMed 20347286Berry MJ, Rejeski WJ, Miller ME, Adair NE, Lang W, Foy CG, Katula JA. A lifestyle activity intervention in patients with chronic obstructive pulmonary disease. Respir Med. 2010 Jun;104(6):829-39. doi: 10.1016/j.rmed.2010.02.015. Epub 2010 Mar 26.
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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.
Michael J. Berry, PhD principal investigator
Wake Forest University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lifestyle Activity Program and Exercise Program in people with Pulmonary Disease, Chronic Obstructive and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI) 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 15 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 29 Jul 2016. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Amount of time engaged in moderate physical activity each week (time frame: Measured at Year 1). 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 NCT00328484, which also lists 4 linked publications.
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 29 Jul 2016.