Pulmonary Disease, Chronic ObstructiveNCT04159129
Effects of Pulmonary Rehabilitation on Walking Speed in Patients With COPD or ILD Patients
An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 7 Nov 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with COPD or ILD who fulfill the inclusion criteria will be recruited during an inpatient pulmonary Rehabilitation program.
Who may be able to join
- Participation in a pulmonary Rehabilitation program (Schön Klinik BGL)
- Indication: COPD or ILD
- COPD; FEV1 <50%
- ILD: FVC <70%
- written informed consent
Who cannot join
- non compliance
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Schön Klinikum Berchtesgadener Land
Schönau am Königssee, Bavaria, 83471
Klaus Kenn, Dr. med., 0049-8652-93 ext. 1540, kkenn@schoen-kliniken.de
Klaus Kenn, Dr. med.
About this study
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)
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).
Read the 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.
- Keywords
- walking speed, dyspnoe, stress, anxiety, traffic light
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
change of maximum walking speed
assessed during a walk of 11m
Measured: Day 1 and Day 21
Secondary outcomes (11)
Change of usual walking Speed
assessed during a walk of 11m by using the individual daily life Walking Speed.
Measured: Day 1 and Day 21
Change in balance
measured by the Leonardo platform
Measured: 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)
Measured: 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)
Measured: Day 1 and Day 21
Change of exercise capacity
measured by the sit-to-stand test, test duration: 1 minute
Measured: Day 1 and Day 21
Change in maximum leg strength
measured by the microfet, knee Extension
Measured: 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
Measured: 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"
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start7 Nov 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Psychologische Hochschule Berlin
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
- Investigators
- Klaus Kenn, Prof., Principal investigator, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159129
- Sponsor's protocol ID
- Ampel2019
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04159129
- Acronym / sponsor ID
- Ampel2019
- Keywords
- walking speed, dyspnoe, stress, anxiety, traffic light
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Psychologische Hochschule Berlin
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with COPD or ILD who fulfill the inclusion criteria will be recruited during an inpatient pulmonary Rehabilitation program.
Key inclusion criteria (5 listed)
- Participation in a pulmonary Rehabilitation program (Schön Klinik BGL)
- Indication: COPD or ILD
- COPD; FEV1 <50%
- ILD: FVC <70%
- written informed consent
Key exclusion criteria (1 listed)
- non compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change of maximum walking speed
Time frame: Day 1 and Day 21
assessed during a walk of 11m
11 secondary outcomes
Change of usual walking Speed
Time frame: Day 1 and Day 21
Change in balance
Time frame: Day 1 and Day 21
Change in walking speed during a field walk test
Time frame: Day 1 and Day 21
Change in tension symptoms during a field walk test
Time frame: Day 1 and Day 21
Change of exercise capacity
Time frame: Day 1 and Day 21
Change in maximum leg strength
Time frame: Day 1 and Day 21
Change in anxiety and Depression symptoms
Time frame: Day 1 and Day 21
Change of frailty (FFP)
Time frame: Day 1 and Day 21
Change in Quality of life: Chronic Respiratory Disease Questionnaire (CRQ)
Time frame: Day 1 and Day 21
Change in illness perception
Time frame: Day 1 and Day 21
Change in COPD-related fears on disease-specific disability
Time frame: Day 1 and Day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Kenn, Prof. principal investigator
Schön Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive and Lung Diseases, Interstitial, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Klaus Kenn, Prof. (0049865293 ext. 1730, kkenn@schoen-klinik.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of maximum walking speed (time frame: Day 1 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.