on-interventional cross-over study to reduce items of the draft PROactive tools as a measure of physical activity in daily life in patients with COPD

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; COPD; 10006436

• Registration Number: NL-OMON37932
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 56

Inclusion Criteria

1. Provision of signed, written, and informed consent prior to conducting any study specific procedures
2. Men or women, >=40 years of age
3. Diagnosis of COPD (GOLD criteria: post bronchodilator FEV1/FVC<70%) confirmed with spirometry in stable clinical conditions. For patients recruited during an exacerbation, the diagnosis of COPD should be confirmed in stable conditions.
4. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year)
5. Able to read and write and to use electronic devices and physical activity monitor

Exclusion Criteria

1. Orthopaedic, neurological or other complaints that significantly impair normal biomechanical movement patterns, as judged by the investigator
2. Respiratory diseases other than COPD (e.g. asthma)
3. COPD exacerbation within 4 weeks prior to Visit 1 (only applicable for patients in the stable group)
4. Cognitive impairment, as judged by the investigator
5. Involvement in the planning and/or conduct of the study
6. Previous randomisation in the present study

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the inital validation and itemreduction of the<br /><br>draft questionnaire.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>