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 | Not Yet Recruiting

• 1 other identifier: F-26039596
• Study Type: observational
• Target: 840
• Locations: 0 countries
• Sites: N/A

Brief 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

Heart Disease; COPD

Keywords

heart disease; COPD; Exercise training; Physical activity; Physical function; Quality of life; Muscoloskeletal pain; Adherence

Outcome Measures

Primary Outcomes (1)

• Six minutes walk test

  Distance walked in six minutes

  from baseline to six weeks and 12 weeks

Secondary Outcomes (4)

• 30 sec chair stand test

  Baseline to six weeks and 12 weeks

• EuroQol 5-Dimension

  Baseline to 12 weeks

• Muscoloskeletal pain

  Baseline to six weeks and 12 weeks

• Physical activity

  From baseline to 24 weeks

Other Outcomes (3)

• Adherence to the training intervention registration

  Baseline to 12 weeks

• Dropout of the training intervention

  Baseline to 12 weeks

• Satisfaction with treatment questionaire

  Baseline to 12 weeks

Study Arms (1)

Rehabilitation group

Patients with heart disease or COPD that are referred to exercise training in a rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart disease or the lung disease COPD refered to out-patient exercise training during rehabilitation

You may qualify if:

• Patients from North Zealand Hospital (Hillerød and Frederikssund) referred with a rehabilitation plan for group-based rehabilitation for myocardial ischemia, heart failure, or COPD at North Zealand Hospital
• Patient consent to participate in the project

You may not qualify if:

• None

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Related Publications (1)

• References 1 Dibben GO, Faulkner J, Oldridge N, et al.: Exercise-based cardiac rehabilitation for coronary heart disease: a meta-analysis. European Heart Journal 2023;44:452.doc:695b90bef87f303feb9c923b1(6) 2 Molloy CD, Long L, Mordi IR, et al.: Exercise-based cardiac rehabilitation for adults with heart failure - 2023 Cochrane systematic review and meta-analysis. European J of Heart Fail 2023;25:2263.doc:695b92b8f87f303feb9c92441(12) 3 Shields GE, Wells A, Doherty P, et al.: Cost-effectiveness of cardiac rehabilitation: a systemat-ic review. Heart 2018;104:1403.doc:695ba4b47d51ae13acc1ab991(17) 4 Tian X, Liu F, Li F, et al.: A Network Meta-Analysis of Aerobic, Resistance, Endurance, and High-Intensity Interval Training to Prioritize Exercise for Stable COPD. COPD 2024;Volume19:2035.doc:695b96e2bcf8ef34cffa42a91 5 Liu S, Zhao Q, Li W, et al.: The Cost-Effectiveness of Pulmonary Rehabilitation for COPD in Different Settings: A Systematic Review. Appl Health Econ Health Policy 2020;19:313.doc:695ba5d16976963cbb24f1161(3) 6 DHRD Årsrapport 2024:doc:695ba9757d51ae13acc1aec91 7 Sommer CG, Jorgensen LB, Blume B, et al. Dropout during a 12-week transitional exercise-based cardiac rehabilitation programme: a mixed-methods prospective cohort study. Eur J Car-diovasc Nurs 2022,21(6):578-86. 8 Ibsen C, Katholm KK, Jakobsen A, et al. Reducing dropout rates in cardiac rehabilitation among cardiac patients in a vulnerable situation: systematic development and feasibility testing of the Heart Priority Programme. BMC Health Serv Res 2024,24(1):1579-x. 9 Mikkelsen T, Korsgaard Thomsen K, Tchijevitch O. Non-attendance and drop-out in cardiac rehabilitation among patients with ischaemic heart disease. Dan Med J 2014,61(10):A4919. 10 Damlund ARS, Jorgensen LB, Blume B, et al. Reasons for dropout in the transition from hospital to municipality during exercise-based cardiac rehabilitation in a Danish cross-sectorial setting: a qualitative study. BMJ Open 2022,12(11):e064660-064660. 11 St

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Stig Molsted, PhD

CONTACT

004531959849; stig.moelsted@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 26 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share