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

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)

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).

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

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.

• Study Type: Observational
• Enrollment (Anticipated): 43

Contacts and Locations

• Study Contact: Name: Klaus Kenn, Prof.; Phone Number: 1730 0049865293; Email: kkenn@schoen-klinik.de
• Study Contact Backup: Name: Inga Jarosch, PhD; Phone Number: 1730 0049865293; Email: ijarosch@schoen-klinik.de

Study Locations

• Germany
  • Bavaria
    • Schönau am Königssee, Bavaria, Germany, 83471
      • Recruiting
      • Schön Klinikum Berchtesgadener Land
      • Contact: Klaus Kenn, Dr. med.; Phone Number: 1540 0049-8652-93; Email: kkenn@schoen-kliniken.de
      • Principal Investigator: Klaus Kenn, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change of maximum walking speed	assessed during a walk of 11m	Day 1 and Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of usual walking Speed	assessed during a walk of 11m by using the individual daily life Walking Speed.	Day 1 and Day 21
Change in balance	measured by the Leonardo platform	Day 1 and Day 21
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
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
Change of exercise capacity	measured by the sit-to-stand test, test duration: 1 minute	Day 1 and Day 21
Change in maximum leg strength	measured by the microfet, knee Extension	Day 1 and Day 21
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land
• Collaborators: Psychologische Hochschule Berlin
• Investigators: Principal Investigator: Klaus Kenn, Prof., Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: anxiety; stress; walking speed; dyspnoe; traffic light
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
• Other Study ID Numbers: Ampel2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No