Modifying Exercise for the COPD Patient

August 20, 2018 updated by: Angela N Fellner PhD CCRP

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

33

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • TriHealth Fitness and Health Pavilion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A cohort of 25 COPD patients (total N = 50) with osteoarthritis undergoing an exercise plan in a pulmonary rehab program.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Exercise Sessions Attended
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Distance Walked
Time Frame: 6 minutes
6 minutes

Other Outcome Measures

Outcome Measure
Time Frame
Dyspnea Score
Time Frame: Two years
Two years
Rate of Perceived Exertion
Time Frame: 30 minutes
30 minutes
Pain Index Score
Time Frame: 30 minutes
30 minutes
Dartmouth Quality of Life Index
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angela N Fellner PhD CCRP

Investigators

  • Principal Investigator: Craig Eisentrout, MD, TriHealth Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12026-12-024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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