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
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Following standard referral after diagnosis of myocardial ischemia, heart failure, or COPD, patients are offered structured outpatient rehabilitation programmes in which supervised physical exercise is a key component. Depending on diagnosis and risk stratification, rehabilitation is delivered at North Zealand Hospital and/or in collaborating municipalities.
This prospective intervention study without a control group is conducted in routine clinical practice. Participants are invited when they enroll in existing group-based rehabilitation programmes. The intervention itself is not experimental and follows standardized, implemented rehabilitation protocols.
Patients with myocardial ischemia and heart failure participate in six weeks of supervised group-based exercise at the hospital, twice weekly, followed by six weeks of rehabilitation in municipal settings. Patients with COPD participate in group-based exercise for up to 12 weeks delivered at the hospital or via telerehabilitation. Exercise sessions include warm-up, aerobic interval training, light resistance training for major muscle groups, and stretching, with intensity guided by the Borg Rating of Perceived Exertion scale.
The primary focus of the study is participation (enrollment, attendance, and dropout) and satisfaction with rehabilitation. Secondary outcomes include changes in physical function, quality of life, musculoskeletal pain, and physical activity. Measurements are obtained before and after the hospital-based rehabilitation period, after any municipal rehabilitation period, and for physical activity additionally at three months after completion.
Sociodemographic and clinical variables obtained from questionnaires and patient records are used to examine factors associated with participation, dropout, and changes in outcomes. The study aims to generate real-world evidence to support optimization of rehabilitation delivery and continuity across healthcare sectors.
Study Type Observational Patient Registry / Prospective Cohort
Conditions
Myocardial Ischemia Heart Failure Chronic Obstructive Pulmonary Disease (COPD)
Interventions Intervention Type: Other Intervention Name: Standard outpatient exercise-based rehabilitation Description: Standardized, guideline-based group exercise programmes delivered as part of routine cardiac and pulmonary rehabilitation (hospital-based, municipal-based, and telerehabilitation).
Outcome Measures Participation and adherence Enrollment rate, attendance rate, and dropout during hospital- and municipality-based rehabilitation Time frame: Up to 12 weeks Satisfaction with rehabilitation (questionnaire) Time frame: End of hospital-based rehabilitation and follow-up 30-second sit-to-stand test Six-minute walk test Time frame: Baseline, post-rehabilitation, and follow-up Quality of life EQ-5D (heart disease) COPD Assessment Test (CAT) Time frame: Baseline, post-rehabilitation, follow-up Musculoskeletal pain Numeric Rating Scale (five body regions) Time frame: Baseline, post-rehabilitation, follow-up Physical activity level Modified IPAQ questionnaire Time frame: Baseline, post-rehabilitation, and three months after completion
Eligibility Criteria Inclusion Criteria Adults referred from North Zealand Hospital (Hillerød or Frederikssund) with a rehabilitation plan for group-based rehabilitation for myocardial ischemia, heart failure, or COPD Enrollment in standard outpatient rehabilitation Provided informed consent Exclusion Criteria None
Enrollment Estimated enrollment: 840 participants
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Stig Molsted, PhD
- Telefonnummer: 004531959849
- E-post: stig.moelsted@regionh.dk
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Rehabilitation group
Patients with heart disease or COPD that are referred to exercise training in a rehabilitation program
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Six minutes walk test
Tidsramme: from baseline to six weeks and 12 weeks
|
Distance walked in six minutes
|
from baseline to six weeks and 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
30 sec chair stand test
Tidsramme: Baseline to six weeks and 12 weeks
|
Number of repetitions of rises from a chair in 30 sec
|
Baseline to six weeks and 12 weeks
|
|
EuroQol 5-Dimension
Tidsramme: Baseline to 12 weeks
|
Quality of life questionaire with index scores from 0-1 and visual analog scale from 0-100, where higher score indicates better health in both
|
Baseline to 12 weeks
|
|
Muscoloskeletal pain
Tidsramme: Baseline to six weeks and 12 weeks
|
Muscoloskeletal pain in five body sites Numeric Rating Scale 0-10
|
Baseline to six weeks and 12 weeks
|
|
Physical activity
Tidsramme: From baseline to 24 weeks
|
Questionaire fra the Danish Health and Morbidity Survey
|
From baseline to 24 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dropout of the training intervention
Tidsramme: Baseline to 12 weeks
|
Participations' dropout during the training intervention period
|
Baseline to 12 weeks
|
|
Adherence to the training intervention registration
Tidsramme: Baseline to 12 weeks
|
Training intervention adherence registered as participation relative to scheduled training sessions in percentage
|
Baseline to 12 weeks
|
|
Satisfaction with treatment questionaire
Tidsramme: Baseline to 12 weeks
|
Satisfaction with intervention assessed using a local questionaire with five questions that are replyed from 1-5 where higher score is more agree
|
Baseline to 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- F-26039596
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .