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NCT02143206 Clinical Trial

Modifying Exercise for the COPD Patient

Pain Clinical Trial

Official title:
Modifying Exercise for the COPD Patient With Arthritic Limitations to Improve Compliance in a Pulmonary Rehab Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02143206
Other study ID # 12026-12-024
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2012
Est. completion date May 2014

Study information
Verified date August 2018
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- 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%

Exclusion Criteria:

- Patients with rheumatoid arthritis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States TriHealth Fitness and Health Pavilion Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Angela N Fellner PhD CCRP

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Dyspnea Score Two years
Other Rate of Perceived Exertion 30 minutes
Other Pain Index Score 30 minutes
Other Dartmouth Quality of Life Index 1 year
Primary Number of Exercise Sessions Attended 2 years
Secondary Distance Walked 6 minutes
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