Clinical trial NCT04159129: Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
Official title: Effects of a Three-week Inpatient Pulmonary Rehabilitation Program on Walking Speed in Patients With Chronic Obstructive Pulmonary Disease (COPD) or Interstitial Lung Diseases (ILD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Interstitial
Keywords: walking speed
dyspnoe
stress
anxiety
traffic light
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Psychologische Hochschule Berlin
First posted: 2019-11-12
Enrollment: 43
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with COPD or ILD who fulfill the inclusion criteria will be recruited during an inpatient pulmonary Rehabilitation program.

Brief summary: The aim of this study is to evaluate the effects of a three-week inpatient pulmonary rehabilitation (PR) program on the walking speed in patients with chronic obstructive (COPD) or interstitial lung disease (ILD).

Detailed description: At most german traffic light crossings, a walking speed of 1,2m/sec is required to cross the road in time. Patients who are unable to cross the road at this speed, expose themselves to an increased level of stress and possibly the risk of accidents. Thus, they are discouraged from participating in an active social life.

An UK study (Nolan et al., Thorax 2018) showed that only 10.7% of the 926 patients with moderate COPD attained a walking speed of 1.2m/sec. As PR plays a key role in the management of chronic lung diseases in order to improve patients´ exercise capacity, the aim of this study was to evaluate the PR effects on the Walking Speed in patients with COPD or ILD. The investigators hypothesize that PR improves the ability to cross the road in the appropriate time.

Eligibility criteria: Inclusion Criteria:

* Participation in a pulmonary Rehabilitation program (Schön Klinik BGL)
* Indication: COPD or ILD
* COPD; FEV1 \<50%
* ILD: FVC \<70%
* written informed consent

Exclusion Criteria:

* non compliance

Primary outcomes:
measure: change of maximum walking speed
timeFrame: Day 1 and Day 21
Secondary outcomes:
measure: Change of usual walking Speed
timeFrame: Day 1 and Day 21
measure: Change in balance
timeFrame: Day 1 and Day 21
measure: Change in walking speed during a field walk test
timeFrame: Day 1 and Day 21
measure: Change in tension symptoms during a field walk test
timeFrame: Day 1 and Day 21
measure: Change of exercise capacity
timeFrame: Day 1 and Day 21
measure: Change in maximum leg strength
timeFrame: Day 1 and Day 21
measure: Change in anxiety and Depression symptoms
timeFrame: Day 1 and Day 21
measure: Change of frailty (FFP)
timeFrame: Day 1 and Day 21
measure: Change in Quality of life: Chronic Respiratory Disease Questionnaire (CRQ)
timeFrame: Day 1 and Day 21
measure: Change in illness perception
timeFrame: Day 1 and Day 21
measure: Change in COPD-related fears on disease-specific disability
timeFrame: Day 1 and Day 21
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Schön Klinikum Berchtesgadener Land
state: Bavaria
Study officials:
affiliation: Schön Klinik Berchtesgadener Land
name: Klaus Kenn, Prof.
role: PRINCIPAL_INVESTIGATOR
References: