Can a physical activity programme or pulmonary rehabilitation reduce the risk of heart and circulation disease in people with COPD?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: At visit 1, the investigators will use https://www.sealedenvelope.com for randomisation following consent. The ratio for randomisation will be 2:2:1 (pulmonary rehabilitation: physical activity: usual care respectively). The researchers will measure waist circumference, body fat percentage, weight and arterial stiffness and will take blood. The participants will complete questionnaires on risk factors for CVD, breathlessness, health status, COPD knowledge, impact of COPD on their life, anxiety and depression, and self‐efficacy. They will also undergo two tests of their exercise capacity. During the week before the intervention starts, participants will wear an ActiGraph physical activity monitor. In a subgroup study, 20 participants will have additional visits and measures. These include magnetic resonance imaging (MRI) to assess fat tissue around the abdomen and a postprandial lipaemic test before and after the intervention to allow for comparison. Participants assigned to the physical activity group will be given a FitBit Charge 2 (a heart rate and fitness wristband that tracks activity and exercise). This is a watch that also measures physical activity levels and allows the investigators to provide feedback to the participant through the watch. The device cannot be worn when doing water‐based activities (such as bathing, showering, swimming etc.). The FitBit Charge 2 will be tracking participants in order to verify their step count. Researchers will not have access to the GPS tracking data. If the participant reaches their initial steps target, the researchers will increase the target by 500 steps. The target calculation will be obtained by calculating the mean of the four most active days plus 500 steps and if it is achieved, the target has been met and a new target will be set at an additional 500 steps. However, if the mean of the four most active days does not exceed the target then the researchers will calcu CONDITION: Cardiovascular disease in people with chronic obstructive pulmonary disease (COPD) ; Circulatory System SECONDARY OUTCOME: ; 1. Waist circumference measured at the narrowest part of the torso above the umbilicus and below the xiphoid process using a measuring tape before and after the intervention; 2. Body fat in percentage will be measured in %BF using bioelectrical impedance analysis before and after the intervention; 3. Fasted triglyceride concentration in blood before and after the intervention; 4. Fasted total cholesterol concentration in blood before and after the intervention; 5. Fasted high‐density lipoprotein (HDL) cholesterol concentration in blood before and after the intervention; 6. Fasted low‐density lipoprotein cholesterol concentration in blood before and after the intervention; 7. Fasted C‐reactive protein (CRP) concentration in blood before and after the intervention; 8. Fasted insulin concentration in blood before and after the intervention; 9. Fasted glucose concentration in blood before and after the intervention; 10. Arterial stiffness assessed using aortic pulse wave velocity will be used to assess arterial stiffness, an independent predictor of cardiovascular disease risk. A noninvasive device (Vicorder) will be used to assess arterial stiffness which measures pulse wave velocity between the carotid and the femoral arteries.; 11. Risk of developing CVD over the next 10 years assessed using the QRISK2 questionnaire before and after the intervention; 12. Weight in kg will be measured using an electronic measuring station before and after the intervention; 13. Body mass index in kg/m2 will be calculated from height in cm and weight in kg before and after the intervention; 14. Effect of breathlessness on mobility assessed using the Medical Research Council dyspnoea scale before and after the intervention; 15. Breathlessness assessed using the Borg Dyspnoea Scale before and after the intervention; 16. Step counts per day measured using an actigraph physical activity monitor. Participants will wear the device for one week at week 1 (before the intervention) and week 8 (after the intervention).; 17. Health status assessed using the Chronic Respiratory Disease Questionnaire Self‐Reported (CRQ‐SR) before and after the intervention; 18. COPD knowledge assessed using the Bristol COPD Knowledge Questionnaire (BCKQ) before and after the intervention; 19. Impact of COPD on a person's life assessed using the COPD Assessment Test (CAT) Questionnaire before and after the intervention; 20. Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS) before and after the intervention; 21. Self‐efficacy assessed using the Pulmonary Rehabilitation Adapted Index of Self‐Efficacy (PRAISE) before and after the intervention. PRAISE is a tool that predicts the reduction in sedentary time following pulmonary rehabilitation in individuals with COPD.; 22. Exercise capacity assessed using the Incremental Shuttle Walking Test (ISWT) before and after the intervention; 23. Exercise capacity assessed using the endurance shuttle walk test (ESWT) before and after the intervention; 24. Postprandial triglyceride concentrations in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial TAG response. The test will be conducted before and after the intervention in a sub‐group of participants.; 25. Postprandial total cholesterol concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial total cholesterol response. The test will be conducted before and after the intervention in a sub‐group of participants.; 26. Postprandial high‐density lipoprotein cholesterol concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial high‐density lipoprotein cholesterol response. The test will be conducted before and after the intervention in a sub‐group of participants.; 27. Postprandial low‐density lipoprotein cholesterol concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial low density lipoprotein cholesterol response. The test will be conducted before and after the intervention in a sub‐group of participants.; 28. Postprandial total C‐reactive protein (CRP) concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial C‐reactive protein response. The test will be conducted before and after the intervention in a sub‐group of participants.; 29. Postprandial total insulin concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial insulin response. The test will be conducted before and after the intervention in a sub‐group of participants.; 30. Postprandial total glucose concentration in blood measured after an overnight fast and 4 h after consuming a high‐fat meal to measure the postprandial glucose response. The test will be conducted before and after the intervention in a sub‐group of participants.; 31. Visceral adipose tissue quantified before the intervention using magnetic resonance imaging (MRI).; INCLUSION CRITERIA: 1. Willing and able to give informed consent for participation in the study 2. Aged 40 years to 85 years. 3. Diagnosed with COPD 4. Able (in the Investigators opinion) and willing to comply with all study requirements. 5. Participant is willing to attend visits at baseline and 8 weeks (sub‐group: baseline, 8 weeks) 6. Able to read and understand English PRIMARY OUTCOME: ; Feasibility will be determined using, but not restricted to, the following criteria:; 1. How many patients are eligible for inclusion (i.e. meet the inclusion criteria); 2. Recruitment/response rate (i.e. number and proportion of those eligible who consent to take part); 3. Refusal rate; 4. Willingness of patients to be recruited and randomised to either intervention or usual care and the willingness of healthcare professionals to refer to this study and future trials; 5. Service provider and multi‐disciplinary team willingness and ability to deliver the new intervention; 6. Suitability of the inclusion criteria; 7. Acceptability, utility and practicality of evaluation measures regarding burden of measurement and compliance; 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 baseline and follow‐up data as well as data completeness and accuracy (including changes in clinical health outcome measures); 11. The acceptability (how individual recipients react to the intervention) of the rehabilitation programme and the research trial will be assessed through interview; 12. Feasibility of conducting outcome measures to compare the effectiveness of physical activity intervention and the conventional pulmonary rehabilitation programme outcomes; 13. Feasibility of investigating arterial stiffness response to pulmonary rehabilitation programme and physical activity interventions; 14. Feasibility of investigating postprandial lipaemia response before and after interventions as a sub‐group study; 15. Feasibility of investigating the relationship between visceral adipose lipid amount and study outcomes as a sub‐group study;
Epistemonikos ID: d06d0eff6b3e210e323b9b54fdf22bffe2ff3696
First added on: Aug 24, 2024