Coronary DiseaseEx-6-rateNCT04898296
Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions
An observational study of Coronary Disease and Exercise Test, run by Klinik Barmelweid at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Coronary Disease, Exercise Test, Physical Exertion
- What is being tested?
- Questionnaire, Interview and Focus Group
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2021to 14 Aug 2022
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from the department of cardiology in the rehabilitation centre of Klinik Barmelweid AG,
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Disease, Exercise Test, Physical Exertion, Cardiac Rehabilitation, Physical Therapy
- Being tested
- Questionnaire, Interview, Focus Group
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire, InterviewOther
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.
Focus GroupOther
The focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Patients over 55 Years with coronary heart disease | Questionnaire and semistructured Interview 45 -60 minutes Receives: Other: Questionnaire, Interview | |
| physical therapists working with patients with coronary heart disease | Focus group 60 -90 minutes Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
semi-structured interview about reasons, that could influence the rating of patients
Patients were asked in a semi-structured interview about other reasons, that could influence their rating.
Measured: 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
physical therapists identify reasons in a focus group, that influence the patients.
Measured: with the beginning of the study within 4 weeks, before the patients' questionnaire and interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Jul 2021
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Barmelweid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilbert Busching, Klinik Barmelweid
- Investigators
- Gilbert Büsching, Principal investigator, Klinik Barmelweid AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898296
- Sponsor's protocol ID
- 001
- Acronym
- Ex-6-rate
- Status last verified
- Oct 2022
- First submitted
- 5 May 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19618202Pollentier 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.
PubMed 20467515
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04898296
- Acronym / sponsor ID
- Ex-6-rate / 001
- Conditions
- Coronary Disease, Exercise Test, Physical Exertion, Cardiac Rehabilitation, Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Klinik BarmelweidUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 24 May 2021 (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 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients over 55 Years with coronary heart disease | – | Other: Questionnaire, InterviewQuestionnaire and semistructured Interview 45 -60 minutes |
| physical therapists working with patients with coronary heart disease | – | Other: Focus GroupFocus group 60 -90 minutes |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from the department of cardiology in the rehabilitation centre of Klinik Barmelweid AG,
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire, InterviewDuring 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. | Other | Patients over 55 Years with coronary heart disease |
| Focus GroupThe focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes). | Other | physical therapists working with patients with coronary heart disease |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Background: PubMed 19618202Jehn 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.
- Background: PubMed 20467515Pollentier 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.
- Nationaler Verein für Qualitätsentwicklung in Spitälern und Kliniken. ANQ; Nationaler Vergleichsbericht 2018 - Kardiale Rehabilitation \[Internet\]. Messergebnisse Rehabilitation. 2018 \[zitiert 7. Dezember 2020\].Link provided by the sponsor.
- 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.
Gilbert Büsching principal investigator
Klinik Barmelweid AG
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 Coronary Disease and Exercise Test, run by Klinik Barmelweid at 1 site in Switzerland.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 25 Oct 2022. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04898296, which also lists 2 linked publications.
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 25 Oct 2022.