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Outpatient Rehabilitation Programmes for Myocardial Ischemia, Heart Failure, and COPD: Satisfaction, Participation, Test Outcomes, and Factors Associated With Positive Changes in Test Results as Well as Level of Participation

NCT07591792 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 840

Last updated 2026-05-19

No results posted yet for this study

Summary

Aim The aim of this project is to investigate the level of participation, satisfaction, changes in tests, and factors associated with these results in existing rehabilitation programmes at North Zealand Hospital and in the surrounding municipalities among patients with heart diseases and the lung disease chronic obstructive pulmonary disease (COPD). The project is conducted in clinical practice in a non-selected population.

Participants Individuals with heart disease and COPD who commence training at North Zealand Hospital. Up to 840 participants may be included over a two-year period. Participants will be recruited at the start of training at North Zealand Hospital.

Inclusion criteria:

Patients from North Zealand Hospital (Hillerød and Frederikssund) referred with a rehabilitation plan for group-based rehabilitation for heart disease or COPD at North Zealand Hospital Patient consent to participate in the project. There are no exclusion criteria for the project.

Intervention Participants will be invited to participate in the project when enrolling in the already existing group-based training programme lasting 6-10 weeks as part of rehabilitation for heart disease and COPD.

Data

Participation:

Number of patients commencing the training period relative to the number of patients referred from the cardiology department

Attendance:

Number of completed training sessions relative to the total number of possible training sessions during the periods at the hospital and in the municipalities

Dropout:

Dropout during the hospital-based and municipality-based periods and reasons for dropout The data listed below will, as far as possible, be collected before and after the training period. Physical activity (the final variable) will additionally be measured three months after completion of the municipal programme.

30-second sit-to-stand test\* Six-minute walk test\* Quality of life measured using the CAT questionnaire for COPD and EQ-5D for the two groups of patients with heart disease Musculoskeletal pain measured using a questionnaire with the Numeric Rating Scale for five body regions Physical activity measured using a modified version of the IPAQ questionnaire from the Danish Health and Morbidity Surveys

\*These tests are standard and implemented in the existing rehabilitation programmes.

Other Data

Additional data will include:

From questionnaire: educational level and BMI (height and weight) From patient records: age, sex, treatment for heart disease, and extent of other chronic diseases Data from patient records are already collected as part of routine clinical practice independently of this project.

Ethics Participants will be invited to the study with written and oral information. Participation will take place after informed consent. The study will be conducted in accordance with the regulations of the Scientific Ethical Committee, to which it will be submitted as soon as possible, and it will be reported in the Capital Region of Denmark's legal system via PRIVACY. The study will be registered in the project database www.clinicaltrials.gov. Data will be stored in the REDCap database system.

Dissemination of Results Results will be presented at local and regional meetings and symposia and published in international peer-reviewed scientific journals indexed in PubMed.

Conditions

Sponsors & Collaborators

  • Nordsjaellands Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2029-03-01
Completion
2029-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591792 on ClinicalTrials.gov