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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04898296
Other study ID # 001
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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