Clinical trial NCT03114241: Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD
Official title: Long-term Effects of a 3-month Pedometer-based Program to Enhance Physical Activity in Patients With Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Physical activity
Endothelial function
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomized 1:1 to one of the two groups: conventional care group or intervention group. No minimization procedures are used.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Long-term evaluation of a coaching program which helps patients with severe COPD to increase their daily step count, in addition to usual care.

Detailed description: Daily physical activity (PA) is a predictor of survival in the general population and has become a significant outcome measure in patients with COPD. Recent studies have demonstrated an independent association between PA, hospitalizations and mortality. Increased PA has significant benefits for patients with COPD. In most studies PA has only been assessed at one time point. Little is known about longitudinal changes in PA and data on determinants of changes in PA are scant. Moreover, information on best approaches to enhance PA in a population with decreasing PA is missing. To evaluate the long-term effect of a coaching program which is aimed at helping patients with severe COPD (FEV1\<50%) to enhance their level of daily physical activity, in addition to usual care. Furthermore, this study aims to evaluate mechanisms that are responsible for changes of physical activity over time such as sociodemographic factors, lung function, comorbidities, vascular function, exacerbations, and medication.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age ≥ 40 years
* Severe COPD (FEV1\<50%) diagnosed according to GOLD-guidelines (www.goldcopd.org)

Exclusion Criteria:

* Physical or intellectual impairment precluding informed consent or protocol adherence
* Acute or recent (within the last 6 weeks) exacerbation of COPD
* Attending a pulmonary rehabilitation program within the last 6 months
* Pregnant patients

Primary outcomes:
measure: Difference between the changes in number of steps per day (assessed over one week) from baseline to 12 months in the intervention group compared to controls.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of endothelial function by flow-mediated dilatation
timeFrame: 12 months
Other outcomes:
measure: Number of COPD exacerbations
timeFrame: 12 months
measure: Height
timeFrame: 12 months
measure: Weight
timeFrame: months
measure: Blood pressure
timeFrame: 12 months
measure: Herat rate
timeFrame: 12 months
measure: Blood gas analysis
timeFrame: 12 months
measure: Questionnaire: Hospital Anxiety and Depression Scale (HADS):
timeFrame: 12 months
measure: Questionnaire: COPD Assessment Test (CAT)
timeFrame: 12 months
measure: Questionnaire: Physical acitivity questionnaire
timeFrame: 12 months
measure: Questionnaire: Short-Form 36 (SF-36) Questionnaire
timeFrame: 12 months
measure: Comorbidities
timeFrame: 12 months
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
affiliation: University of Zurich
name: Christian F Clarenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kohlbrenner D, Sievi NA, Senn O, Kohler M, Clarenbach CF. Long-Term Effects of Pedometer-Based Physical Activity Coaching in Severe COPD: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2020 Nov 6;15:2837-2846. doi: 10.2147/COPD.S279293. eCollection 2020.