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Completed

NCT Number: NCT04898296

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

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.

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Key information

Conditions

Coronary Disease Cardiac Rehabilitation Cardiovascular Diseases Exercise Test Heart Diseases Myocardial Ischemia Physical Exertion Physical Therapy Vascular Diseases

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Barmelweid AG

Barmelweid, Canton of Aargau, 5017, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire, Interview

Other

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

Other

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

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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)

  2. 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)

  3. Patients' exertion and performance limit

    Time frame: during inpatient rehabilitation after the 1st six-minute-walking test within 3 weeks

    open questions

  4. 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)

  5. 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)

  6. 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)

  7. 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)

Sponsors and collaborators

Lead sponsor

Klinik Barmelweid

Other

Registry information

Official study 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

Acronym: Ex-6-rate

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 24, 2021
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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