Chronic Obstructive Pulmonary Disease (COPD) and/or chronic heart failure Respiratory
Conditions
Interventions
This study will be assessing the feasibility of a combined breathlessness exercise rehabilitation programme for patients with COPD and/or heart failure and how feasible it is to recruit patients and c
Sponsors
University Hospital Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be aged between 40 and 85 years 2. Have a physician confirmed diagnosis of COPD and/or heart failure 3. Be referred or due to enrol on the University Hospitals of Leicester (UHL) NHS Trust combined rehabilitation programme 4. Be willing and able to comply with the trial protocol 5. Be able to provide informed consent 6. Meet the ‘UHL Breathlessness Rehabilitation Class Standard Operating Procedure’ criteria for eligible patients
Exclusion criteria
Exclusion criteria: 1. Be under 40 or over 85 years of age 2. Completed or began a rehabilitation programme less than 6 months ago 3. Have had clinical concerns about them raised by rehabilitation staff/not meet the ‘UHL Breathlessness Rehabilitation Class Standard Operating Procedure' 4. Not have a confirmed diagnosis of COPD and/or heart failure 5. Have completed or began a rehabilitation programme in the last 6 months 6. Have insufficient proficiency in English to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility will be determined using, but not restricted to, the following criteria: 1. The number of participants eligible for inclusion (i.e. meet the inclusion criteria) 2. Suitability of the inclusion criteria 3. Recruitment/response rate (i.e. number and proportion of those eligible who consent to take part) 4. Refusal rate 5. Uptake and completion of the study 6. Willingness of patients to be recruited and the willingness of healthcare professionals to refer to this study and future trials 7. Service provider and multi-disciplinary teams’ willingness and ability to deliver the new combined exercise rehabilitation programme 8. The practicality of delivering the intervention in the proposed setting 9. The time needed to collect and analyse the data 10. Test methods for the collection of data as well as data completeness and accuracy (including changes in clinical health outcome measures) 11. The acceptability of the combined exercise rehabilitation programme and the COHERE trial will be assessed through focus groups 12. Compliance to the combined exercise rehabilitation programme and COHERE study. Poor programme compliance will be defined as absence from rehabilitation sessions and poor trial compliance will be assessed by absence from outcome measure assessments 13. Adherence to the combined exercise rehabilitation programme assessed via a self-report exercise diary, which is usual care 14. The training and resource needs to deliver the intervention and ensure fidelity (ensuring readiness for a future much larger multi-centre trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cardiometabolic risk assessed by fasted venous blood sample and arterial stiffness, assessed before and upon completion of the rehabilitation programme 2. Body composition, waist circumference and blood pressure measured before and after rehabilitation 3. Physical activity and sedentary behaviour assessed using an ActiGraph accelerometer. The device will be given to participants to wear for 7 consecutive days before and after the rehabilitation programme. Participants will also complete the Pro-ACTIVE physical activity questionnaire 4. Symptoms assessedusing the Multidimensional Dyspnea Profile, Dyspnea 12 Questionnaire and PROMIS fatigue questionnaire before and after the rehabilitation programme 5. Health-related quality of life assessed using the Chronic Heart Questionnaire- Self Report, and the EuroQol 5D-5L questionnaire before and after rehabilitation 6. Frailty levels assessed using the Short Physical Performance Battery before and after the rehabilitation programme 7. Lung function assessed using spirometry and B-Type Natriuretic Peptide levels before rehabilitation Measures that are taken as part of patient's usual care will also be recorded for research purposes. These include: 1. Exercise capacity, measured using the Incremental and Endurance Shuttle Walk Test 2. Muscle strength, measured using the Quadriceps Maximal Voluntary Contraction 3. Breathlessness, measured using the Medical Research Council scale and COPD Assessment Test 4. Mood state, measured using the Hospital and Anxiety Depression Scale 5. Quality of life, measured using the Dartmouth COOPS Charts These are completed in the clinical visits that occur before the rehabilitation programme and at discharge | — |
Countries
United Kingdom
Contacts
Public ContactAmy Jones
Outcome results
None listed