NCT04898296

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 14, 2022

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

May 5, 2021

Last Update Submit

October 24, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Other Outcomes (7)

  • Patients' experience with the conduction of the six-minute-walking test

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

  • Patients' honesty of the statement of effort

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

  • Patients' exertion and performance limit

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

  • +4 more other outcomes

Study Arms (2)

Patients over 55 Years with coronary heart disease

Questionnaire and semistructured Interview 45 -60 minutes

Other: Questionnaire, Interview

physical therapists working with patients with coronary heart disease

Focus group 60 -90 minutes

Other: Focus Group

Interventions

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.

Patients over 55 Years with coronary heart disease

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

physical therapists working with patients with coronary heart disease

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from the department of cardiology in the rehabilitation centre of Klinik Barmelweid AG,

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Barmelweid AG

Barmelweid, Canton of Aargau, 5017, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 19618202BACKGROUND
  • 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.

    PMID: 20467515BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Disease

Interventions

Surveys and QuestionnairesInterviews as TopicFocus Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gilbert Büsching

    Klinik Barmelweid AG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 24, 2021

Study Start

July 1, 2021

Primary Completion

August 14, 2022

Study Completion

August 14, 2022

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations