Chronic Obstructive Pulmonary DiseasePhase 2NCT01058213
Nurse Managed Sequential Strength Training and Bicycle Training in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing Resistance training and Aerobic 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 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status… Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Resistance training and Aerobic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to May 2013
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- FEV1/FVC < 70 and FEV1 < 55%,
- > 45 years of age,
- experience dyspnea with exertion,
- stable clinical condition (Stable clinical condition is defined as 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.)
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,
- currently participating in pulmonary rehabilitation,
- the presence of a potentially debilitating disease or the presence of a condition that would make it potentially unsafe to exercise.
- We will adhere to the American College of Sports Medicine guidelines and exclude those who do not meet their guidelines for exercise testing and training.
- Pregnant women or women who plan to become pregnant during the study.
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 Sequential Resistance Then Aerobic Training in COPD
This is a 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status than bicycle training alone or concurrent bicycle and strength training together.
Read the detailed description
Volunteers are randomly assigned to one of three groups: 1). 8 weeks of resistance (strength) training followed by 8 weeks of bicycle exercise training, 2). 8 weeks of chair exercise followed by 8 weeks of resistance (strength) training and bicycle exercise training, or 3). 8 weeks of chair exercise followed by 8 weeks of bicycle exercise training. The length of the training is 16 weeks for all 3 groups. Volunteers train 3 days per week in our lab located in the Chicagoland area and are supervised by an exercise specialist.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Resistance training, Aerobic training
- Keywords
- COPD, Pulmonary rehabilitation, Resistance Training, Aerobic Training, Dyspnea
- 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.
Resistance trainingBehavioural
Supervised training will be performed on a cable exercise system (Body Solid, Forest Park, IL) using six exercises that involve concentric and eccentric muscle actions: leg press, knee flexion, knee extension, calf raise, hip adduction, hip abduction. Subjects will perform the lower extremity exercises under the direct supervision of an exercise specialist three times per week. Subjects will perform 2 sets of 8-10 repetitions at 70% of their maximum strength for 2 weeks, then will perform 2 sets of 8-10 repetitions at 80% of their maximal strength for 2 weeks, and for the next 4 weeks they will perform 3 sets of 8-10 repetitions at 80% of their maximal strength. Sets will be separated by at least a 2-3 minute rest period for multiple-joint exercises and at least 1-2 minutes for single-joint exercises. A moderate velocity of muscle contraction (~1-2 seconds for concentric and eccentric contraction) will be used.
Aerobic trainingBehavioural
Cycle ergometry training will be performed in the lab on a stationary cycle ergometer, calibrated with a 4 kg weight (Monark 828E, Varberg, Sweden). Initial work rate will be 50% of peak work rate (PWR) as tolerated and will be evaluated weekly with progressive increases targeted to achieve the highest work rate tolerated for 3-5 minutes{: wks 1-2 50% PWR, wks 3-4 60% PWR, wks 5-6 70% PWR, wks 7-8 80% PWR}. An interval training protocol will be used with subjects performing four work sets of five minutes duration separated by rest intervals of unloaded cycling lasting 2-4 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic training alone | Active comparator | 8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle Receives: Behavioral: Aerobic training |
| Sequential Resistance then Aerobic Training | Experimental | 8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle Receives: Behavioral: Resistance training; Behavioral: Aerobic training |
| Concurrent resistance and aerobic training | Active comparator | 8 weeks of gentle chair (sham) exercise followed by 8 weeks of concurrent resistance training of the lower body and interval aerobic training on a stationary bicycle Receives: Behavioral: Resistance training; Behavioral: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional capacity for aerobic exercise and for common daily activities
Measured: baseline, 16 weeks
functional reserve as measured by the reduction in breathlessness and fatigue
Measured: baseline, 16 weeks
Secondary outcomes (1)
functional performance and functional capacity utilization as measured by the Functional Performance Inventory and the CHAMPS Physical Activity Scale for Older Adults
Measured: baseline, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startNov 2008
- Primary completionMay 2013
- Study completionMay 2013
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.
- More trials run by University of Illinois ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret K. Covey, University of Illinois Chicago
- Investigators
- Margaret K Covey, PhD, RN, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058213
- Sponsor's protocol ID
- NR010249
- Status last verified
- Dec 2013
- First submitted
- 26 Jan 2010
- Last updated
- 18 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Covey MK, Collins EG, Reynertson SI, Dilling DF. Resistance training as a preconditioning strategy for enhancing aerobic exercise training outcomes in COPD. Respir Med. 2014 Aug;108(8):1141-52. doi: 10.1016/j.rmed.2014.06.001. Epub 2014 Jun 11.
PubMed 24958605
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Managed Sequential Resistance Then Aerobic Training in COPD
- ClinicalTrials.gov ID
- NCT01058213
- Acronym / sponsor ID
- NR010249
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Pulmonary rehabilitation, Resistance Training, Aerobic Training, Dyspnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 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 16 week exercise training program for people with severe to very severe chronic obstructive pulmonary disease (COPD). The purpose of this study is to find out if performing strength training prior to initiating exercise training on a stationary bicycle is associated with greater gains in functional status than bicycle training alone or concurrent bicycle and strength training together.
Detailed description
Volunteers are randomly assigned to one of three groups: 1). 8 weeks of resistance (strength) training followed by 8 weeks of bicycle exercise training, 2). 8 weeks of chair exercise followed by 8 weeks of resistance (strength) training and bicycle exercise training, or 3). 8 weeks of chair exercise followed by 8 weeks of bicycle exercise training. The length of the training is 16 weeks for all 3 groups. Volunteers train 3 days per week in our lab located in the Chicagoland area and are supervised by an exercise specialist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic training alone | Active comparator | Behavioral: Aerobic training8 weeks of gentle chair (sham) training followed by 8 weeks of interval aerobic training on a stationary bicycle |
| Sequential Resistance then Aerobic Training | Experimental | Behavioral: Resistance training, Behavioral: Aerobic training8 weeks of resistance training of the lower body followed by 8 weeks of interval aerobic training on a stationary bicycle |
| Concurrent resistance and aerobic training | Active comparator | Behavioral: Resistance training, Behavioral: Aerobic training8 weeks of gentle chair (sham) exercise followed by 8 weeks of concurrent resistance training of the lower body and interval aerobic training on a stationary bicycle |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- FEV1/FVC < 70 and FEV1 < 55%,
- > 45 years of age,
- experience dyspnea with exertion,
- stable clinical condition (Stable clinical condition is defined as 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.)
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,
- currently participating in pulmonary rehabilitation,
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 |
|---|---|---|
| Resistance trainingSupervised training will be performed on a cable exercise system (Body Solid, Forest Park, IL) using six exercises that involve concentric and eccentric muscle actions: leg press, knee flexion, knee extension, calf raise, hip adduction, hip abduction. Subjects will perform the lower extremity exercises under the direct supervision of an exercise specialist three times per week. Subjects will perform 2 sets of 8-10 repetitions at 70% of their maximum strength for 2 weeks, then will perform 2 sets of 8-10 repetitions at 80% of their maximal strength for 2 weeks, and for the next 4 weeks they will perform 3 sets of 8-10 repetitions at 80% of their maximal strength. Sets will be separated by at least a 2-3 minute rest period for multiple-joint exercises and at least 1-2 minutes for single-joint exercises. A moderate velocity of muscle contraction (~1-2 seconds for concentric and eccentric contraction) will be used. | Behavioural | Concurrent resistance and aerobic training, Sequential Resistance then Aerobic Training |
| Aerobic trainingCycle ergometry training will be performed in the lab on a stationary cycle ergometer, calibrated with a 4 kg weight (Monark 828E, Varberg, Sweden). Initial work rate will be 50% of peak work rate (PWR) as tolerated and will be evaluated weekly with progressive increases targeted to achieve the highest work rate tolerated for 3-5 minutes{: wks 1-2 50% PWR, wks 3-4 60% PWR, wks 5-6 70% PWR, wks 7-8 80% PWR}. An interval training protocol will be used with subjects performing four work sets of five minutes duration separated by rest intervals of unloaded cycling lasting 2-4 minutes. | Behavioural | Aerobic training alone, Concurrent resistance and aerobic training, Sequential Resistance then Aerobic Training |
Primary outcome
functional capacity for aerobic exercise and for common daily activities
Time frame: baseline, 16 weeks
functional reserve as measured by the reduction in breathlessness and fatigue
Time frame: baseline, 16 weeks
1 secondary outcome
functional performance and functional capacity utilization as measured by the Functional Performance Inventory and the CHAMPS Physical Activity Scale for Older Adults
Time frame: baseline, 16 weeks
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 18 Dec 2013.
- Derived from this study: PubMed 24958605Covey MK, Collins EG, Reynertson SI, Dilling DF. Resistance training as a preconditioning strategy for enhancing aerobic exercise training outcomes in COPD. Respir Med. 2014 Aug;108(8):1141-52. doi: 10.1016/j.rmed.2014.06.001. Epub 2014 Jun 11.
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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.
Margaret K Covey, PhD, RN principal investigator
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 Resistance training and Aerobic 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 4 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 18 Dec 2013. 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 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?
functional capacity for aerobic exercise and for common daily activities (time frame: baseline, 16 weeks). The study lists 2 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 NCT01058213, 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 18 Dec 2013; AzTrials last refreshed its copy on 3 Nov 2026.