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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02999685
Other study ID # 14-009016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date June 2019

Study information

Verified date January 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.


Description:

This study consists of a home-based pulmonary rehabilitation system. The system consists of a tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls. The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A will complete the study activities during the first 8 weeks of the study followed by a period of observation. Group B will complete 8 weeks of observation followed by 8 weeks of rehabilitation.


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 99 Years
Eligibility Inclusion Criteria:

- • Men and women age 40 years and older

- Current or former smoker of at least 10 pack-years

- Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function

- Are eligible for Pulmonary Rehabilitation

Exclusion Criteria:

- • Unable to perform mild exercises

- Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.

- Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Home-base Pulmonary Rehab with Health Coaching


Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic Minnesota HealthSolutions

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life: Chronic Respiratory Questionaire To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional 8 weeks from the start of the intervention
Primary Daily Physical Activity measured by Actigraph To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers 8 weeks from the start of the intervention
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