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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02100709
Other study ID # RMD_NIV_COPD_001
Secondary ID
Status Terminated
Phase N/A
First received March 27, 2014
Last updated April 28, 2017
Start date April 2014
Est. completion date October 2016

Study information

Verified date April 2017
Source ResMed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:

- the amount of daily physical activity

- Quality of life

- The 6-minute walk distance

- Time to exacerbation

and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria:

- Diagnosis of COPD III+IV

- Age >18 years

- Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher

Exclusion Criteria:

- Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks

- non-pulmonary Exercise impairment (amputation, severe heart disease, etc)

- any disease that precludes exercise training

- inability to understand the patient information

- substance abuse

- oxygen requirement of more than 6l O2/min during exercise

Study Design


Related Conditions & MeSH terms


Intervention

Device:
BiLevel Noninvasive Ventilation
Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.

Locations

Country Name City State
Germany Ruhrlandklinik Tuschen Essen

Sponsors (1)

Lead Sponsor Collaborator
ResMed

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to pulmonary exacerbation The average time to exacerbation between groups will be analysed post trial. 12 Months
Primary Daily Physical Activity The primary outcome will be measured by daily activity using accelerometer arm bands. This will be measured at the beginning of the rehabilitation program, at the end and at a 3 month follow up. 3 Months
Primary Exercise Capacity 6 Minute Walking Distance will be measured every week during the exercise program. 6 Weeks
Secondary Quality of Life Using the St. George Respiratory Questionnaire before and after rehabilitation, quality of life will be measured. 3 Months
Secondary Dyspnoea Change in Dyspnoea after end of exercise will be assessed using the Multidimensional Dyspnoea Profile and the BORG scale. 6 Weeks
Secondary Change in Physiological Parameters Maximum training intensity, body weight and muscle diameter will be tracked throughout the training program. 3 Months
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