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

Sponsor
Nordsjaellands Hospital
Study ID
NCT07591792
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 18, 2026
Start date
Aug 1, 2026
Status verified
May 2026
Primary completion
Mar 1, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
840 participants (estimated)

Arms

  • Arm: Rehabilitation group
    Patients with heart disease or COPD that are referred to exercise training in a rehabilitation program

Primary Outcome Measure

Six minutes walk test [ Time Frame: from baseline to six weeks and 12 weeks ]

Central Contacts

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