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

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)
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)
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.

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.

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

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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