- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898296
Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions (Ex-6-rate)
October 24, 2022 updated by: Gilbert Busching, Klinik Barmelweid
Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions of Patients Over 55 Years of Age With Coronary Heart Disease in 6-min Walking Test in Cardiorespiratory Physiotherapy
The 6-minute walk test is a test of physical performance in physiotherapy with lungs and heart patients (Pollentier 2010).
However, only 8 and 11% of patients in everyday test situations report a score of 7 or higher on a scale of 0-10 for effort (Jehn 2009).
This study is intended to explore, based on grounded theory, why the majority of patients do not assess themselves according to the almost maximum performance.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
16
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Aargau
-
Barmelweid, Aargau, Switzerland, 5017
- Klinik Barmelweid AG
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients from the department of cardiology in the rehabilitation centre of Klinik Barmelweid AG,
Description
Inclusion Criteria:
- Patients with coronary artery disease undergoing in-patient cardiovascular rehabilitation; over 55 years of age. Patients underwent a 6-minute walk test with assessment of the intensity of the exercise
Exclusion Criteria:
- no understanding of the German language
- Patients would not be able to perform a 6-minute walk test, e. g. surgery on the large joints of the lower extremities, unstable heart disease or predominant neurological symptoms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients over 55 Years with coronary heart disease
Questionnaire and semistructured Interview 45 -60 minutes
|
During the stay, a study visit is arranged with the patient after the 6-minute walk test has been performed.
This consists of filling out the questionnaire and an interview, which lasts about 45-60 minutes.
This is carried out by the investigator on at least 5 subjects.
After each interview, a list of influencing factors is kept.
If new aspects continue to appear in the 5th interview, the interviews are continued (up to a maximum of the 10th subject).
If no new aspects appear in the interviews from number 6 onwards, the interviews are discontinued and no further patients are recruited.
The conversations are recorded with an audio recording.
|
|
physical therapists working with patients with coronary heart disease
Focus group 60 -90 minutes
|
The focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
semi-structured interview about reasons, that could influence the rating of patients
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
Patients were asked in a semi-structured interview about other reasons, that could influence their rating.
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
reasons, what might patients influence for ratings of patients given from physical therapist
Time Frame: with the beginning of the study within 4 weeks, before the patients' questionnaire and interview
|
physical therapists identify reasons in a focus group, that influence the patients.
|
with the beginning of the study within 4 weeks, before the patients' questionnaire and interview
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' experience with the conduction of the six-minute-walking test
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
nominal scale (yes-partly-no)
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Patients' honesty of the statement of effort
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
nominal scale (yes-no)
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Patients' exertion and performance limit
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
open questions
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Patients' safety during the six-minute-walking test
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
numeric rating scale 0-10 (more likely no = 0; more likely yes = 10)
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during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Patients' performance limit before and after the heart disease
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
numeric rating scale 0-10 (more likely no = 0; more likely yes = 10)
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Patients' sportiness
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
numeric rating scale 0-10 (more likely no = 0; more likely yes = 10)
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during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
|
Experience of maximal exertion of activity in the past
Time Frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
4-point nominal scale (weekly to several years ago)
|
during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gilbert Büsching, Klinik Barmelweid AG
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jehn M, Halle M, Schuster T, Hanssen H, Weis M, Koehler F, Schmidt-Trucksass A. The 6-min walk test in heart failure: is it a max or sub-maximum exercise test? Eur J Appl Physiol. 2009 Oct;107(3):317-23. doi: 10.1007/s00421-009-1128-0. Epub 2009 Jul 18.
- Pollentier B, Irons SL, Benedetto CM, Dibenedetto AM, Loton D, Seyler RD, Tych M, Newton RA. Examination of the six minute walk test to determine functional capacity in people with chronic heart failure: a systematic review. Cardiopulm Phys Ther J. 2010 Mar;21(1):13-21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Actual)
August 14, 2022
Study Completion (Actual)
August 14, 2022
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
May 18, 2021
First Posted (Actual)
May 24, 2021
Study Record Updates
Last Update Posted (Actual)
October 25, 2022
Last Update Submitted That Met QC Criteria
October 24, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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