Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients

Pulmonary Disease, Chronic Obstructive Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159129
• Other study ID #: Ampel2019
• Status: Recruiting
• Start date: November 7, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2019
• Source: Schön Klinik Berchtesgadener Land
• Contact: Klaus Kenn, Prof.
• Phone: 0049865293
• Email: kkenn[@]schoen-klinik.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: July 31, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Germany	Schön Klinikum Berchtesgadener Land	Schönau am Königssee	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land	Psychologische Hochschule Berlin

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of maximum walking speed	assessed during a walk of 11m	Day 1 and Day 21
Secondary	Change of usual walking Speed	assessed during a walk of 11m by using the individual daily life Walking Speed.	Day 1 and Day 21
Secondary	Change in balance	measured by the Leonardo platform	Day 1 and Day 21
Secondary	Change in walking speed during a field walk test	measured by the time needed to cross a traffic light (distance: 11m)	Day 1 and Day 21
Secondary	Change in tension symptoms during a field walk test	intensity of perceived tension symptoms experienced when crossing a traffic light (VAS scale, ranging from 0 to 10)	Day 1 and Day 21
Secondary	Change of exercise capacity	measured by the sit-to-stand test, test duration: 1 minute	Day 1 and Day 21
Secondary	Change in maximum leg strength	measured by the microfet, knee Extension	Day 1 and Day 21
Secondary	Change in anxiety and Depression symptoms	Anxiety/Depression measured by Hospital Anxiety and Depression Scale (HADS) - a screening questionnaire including seven questions each about Depression and Anxiety; each part ranging from 0 to 21; higher scores indicate higher presence of the respective state	Day 1 and Day 21
Secondary	Change of frailty (FFP)	measured by Fried Frailty Phenotype (FFP), including five constructs (weight loss, exhaustion, physical activity, gait speed and weakness); range 0-5, higher scores reflect increased Frailty: A score of 0 is considered as "robust", a score of 1-2 is considered as "pre-frail", a score lower than 2 reflects "Frailty"	Day 1 and Day 21
Secondary	Change in Quality of life: Chronic Respiratory Disease Questionnaire (CRQ)	assessed by the Chronic Respiratory Disease Questionnaire (CRQ)- a 20-item self-report questionnaire; score 1-7; higher scores indicate a better health-related quality of life	Day 1 and Day 21
Secondary	Change in illness perception	assessed by the Illness perception Questionnaire, revised (IPQ-R) - 18 items, score 1-5; higher scores indicate a worse illness perception, except of item 7,9,10,11,12.	Day 1 and Day 21
Secondary	Change in COPD-related fears on disease-specific disability	assessed by the German "COPD Angst Fragebogen" (CAF) - a 20-item self-report questionnaire, rated on a Lickert-scale (score 0-4); highest maximum score: 80 points; higher scores indicate higher anxiety levels.	Day 1 and Day 21