Exploration of Possible Reasons for the Discrepancy Between Expectation and Indication of Subjective Perceived Exertions

Coronary Disease Clinical Trial

— Ex-6-rate  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04898296
• Other study ID #: 001
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: August 14, 2022

Study information

• Verified date: October 2022
• Source: Klinik Barmelweid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 14, 2022
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Coronary Disease
• Exercise Test
• Physical Exertion
• Physical Therapy

Intervention

Other:
• Questionnaire, Interview
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 Group
The focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes).

Locations

Country	Name	City	State
Switzerland	Klinik Barmelweid AG	Barmelweid	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Barmelweid

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Jehn M, Halle M, Schuster T, Hanssen H, Weis M, Koehler F, Schmidt-Trucksäss 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' experience with the conduction of the six-minute-walking test	nominal scale (yes-partly-no)	during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
Other	Patients' honesty of the statement of effort	nominal scale (yes-no)	during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
Other	Patients' exertion and performance limit	open questions	during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
Other	Patients' safety during the six-minute-walking test	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
Other	Patients' performance limit before and after the heart disease	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
Other	Patients' sportiness	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
Other	Experience of maximal exertion of activity in the past	4-point nominal scale (weekly to several years ago)	during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
Primary	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.	during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks
Primary	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.	with the beginning of the study within 4 weeks, before the patients' questionnaire and interview

External Links

•   Nationaler Verein für Qualitätsentwicklung in Spitälern und Kliniken. ANQ; Nationaler Vergleichsbericht 2018 - Kardiale Rehabilitation [Internet]. Messergebnisse Rehabilitation. 2018 [zitiert 7. Dezember 2020].