Chronic Obstructive Pulmonary DiseaseNCT02143206
Modifying Exercise for the COPD Patient
An observational study of Chronic Obstructive Pulmonary Disease and Arthritis, run by Angela N Fellner PhD CCRP at 1 site in United States.
Trial summary
This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Arthritis, Pain
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2014
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 25 COPD patients (total N = 50) with osteoarthritis undergoing an exercise plan in a pulmonary rehab program.
Who may be able to join
- COPD Patient
- Osteoarthritic limitations in upper or lower extremities, or spine
- Forced Expiratory Volume (FEV)1 less than 70%
- Forced Expiratory Volume/Forced Vital Capacity (FEV/FVC) ratio less than 70%
Who cannot join
- Patients with rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
TriHealth Fitness and Health Pavilion
Cincinnati, Ohio, 45242
About this study
Official title: Modifying Exercise for the COPD Patient With Arthritic Limitations to Improve Compliance in a Pulmonary Rehab Program
This study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. The main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. In addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both groups. It is believed that the new machine will provide better overall outcomes compared to the traditional machine.
Read the detailed description
A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for COPD arthritic patients will occur in an exercise rehabilitation program.
- Conditions
- Chronic Obstructive Pulmonary Disease, Arthritis, Pain
- Keywords
- Chronic Obstructive Pulmonary Disease, Pain, Arthritis, Dyspnea, Exercise, Aerobic
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Arthritis, Pain, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Method | Patients attend exercise 80 minute exercise sessions of which 30 minutes includes aerobic exercise on a NuStep and Biodex elliptical machine. Patients pain levels are scored when using the NuStep then when using the Biodex and these scores are compared to determine which machine give the best outcome for pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Exercise Sessions Attended
Measured: 2 years
Secondary outcomes (1)
Distance Walked
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela N Fellner PhD CCRP
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Angela N Fellner PhD CCRP, TriHealth Inc.
- Investigators
- Craig Eisentrout, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143206
- Sponsor's protocol ID
- 12026-12-024
- Status last verified
- Aug 2018
- First submitted
- 16 May 2014
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifying Exercise for the COPD Patient With Arthritic Limitations to Improve Compliance in a Pulmonary Rehab Program
- ClinicalTrials.gov ID
- NCT02143206
- Acronym / sponsor ID
- 12026-12-024
- Conditions
- Chronic Obstructive Pulmonary Disease, Arthritis, Pain
- Keywords
- Chronic Obstructive Pulmonary Disease, Pain, Arthritis, Dyspnea, Exercise, Aerobic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Angela N Fellner PhD CCRPUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 May 2014 (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 study will test whether using the Biodex BioStep Semi Recumbent Elliptical for the chronic obstructive pulmonary disease (COPD) patient with arthritic limitations will improve participation in a pulmonary rehab program compared to the Nustep elliptical. The main outcome of participation will be measured by the number of exercise sessions the patient is able to complete during their pulmonary rehabilitation program. In addition, distance walked in six minutes, dyspnea score, rate of perceived exertion (RPE) score, Pain Scale Index score, and finally, the Dartmouth Quality of Life index (DQL) will be assessed in both groups. It is believed that the new machine will provide better overall outcomes compared to the traditional machine.
Detailed description
A Prospective cohort study of 25 COPD patients with osteoarthritis undergoing an exercise plan in a pulmonary rehab program. Patient pain level, clinical outcomes, and ultimately, quality of life outcomes will be assessed in order to assess whether future compliance for COPD arthritic patients will occur in an exercise rehabilitation program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Method | – | –Patients attend exercise 80 minute exercise sessions of which 30 minutes includes aerobic exercise on a NuStep and Biodex elliptical machine. Patients pain levels are scored when using the NuStep then when using the Biodex and these scores are compared to determine which machine give the best outcome for pain management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 25 COPD patients (total N = 50) with osteoarthritis undergoing an exercise plan in a pulmonary rehab program.
Key inclusion criteria (4 listed)
- COPD Patient
- Osteoarthritic limitations in upper or lower extremities, or spine
- Forced Expiratory Volume (FEV)1 less than 70%
- Forced Expiratory Volume/Forced Vital Capacity (FEV/FVC) ratio less than 70%
Key exclusion criteria (1 listed)
- Patients with rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Exercise Sessions Attended
Time frame: 2 years
1 secondary outcome
Distance Walked
Time frame: 6 minutes
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 22 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease
Chronic Respiratory Disease, Chronic Obstructive Pulmonary Disease
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Active, not recruitingPhase 3
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
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.
Craig Eisentrout, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease and Arthritis, run by Angela N Fellner PhD CCRP 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 1 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 22 Aug 2018. 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.
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?
Number of Exercise Sessions Attended (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.