Physical Activity Intervention and Cardiovascular Risk Markers in COPD

Study Overview
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Brief Summary
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The Aim of this study is to examine the feasibility of a future trial comparing the impact of a physical activity intervention and a standard pulmonary rehabilitation programme upon cardiovascular risk and symptoms in COPD. The study involved three groups which are physical activity group, pulmonary rehabilitation group and usual care. The physical activity group and the pulmonary rehabilitation group will complete six-weeks of intervention. The pulmonary rehabilitation group will participate in a standard rehabilitation programme of supervised exercise and education sessions. Physical activity group will be involved in a programme that aims to increase their physical activity level with an increasing step count. Usual care group will be monitored for six-weeks. Before and after interventions measures will be taken including exercise capacity, body composition, blood tests, arterial stiffness, questionnaires assessing health quality of life, anxiety and depression, symptoms, cardiovascular disease risk. The investigators will also have a sub-group study. The subgroup study will have two arms interventions which are pulmonary rehabilitation group and physical activity group. The investigators will recruit 10 participants for each group from the main groups' population (no usual care group). Additional before and after measures will be taken for sub-group study and that includes Magnetic resonance imaging (MRI) scanning for adipose visceral tissue and postprandial lipaemic response test. It is hypothesised that exercise and physical activity level can reduce cardiovascular disease risk with COPD patients, but the relative impact of both interventions need to be explored.

Detailed Description
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For those with COPD, both physical activity (PA) interventions and pulmonary rehabilitation (PR) seem to be promising to potentially lower the risk of CVD. PA interventions seem to be promising in improving outcomes of COPD but there is lack of evidence on how the effectiveness of PA interventions compared with the gold standard intervention of PR. However, the outcomes of both interventions have not been extensively investigated, nor have they been directly compared. The immediate effects of pulmonary rehabilitation and PA interventions on cardiovascular risk factors for individuals with COPD have not been extensively investigated or compared. Therefore, the purpose of this study is to examine the feasibility of conducting a trial to compare the impact of pulmonary rehabilitation and physical activity interventions in a number of important clinical outcomes including cardiovascular risk. Investigation and data collection will be taking place within University Hospitals of Leicester NHS trust sites. The investigators are aiming to recruit 50 COPD patients who are eligible for a pulmonary rehabilitation programme to investigate the effect of physical activity intervention compared to pulmonary rehabilitation with respect to cardiovascular risks. The study will measure various outcomes, immediately before, immediately after interventions. These outcomes will include measures in aerobic fitness (walking test), strength tests, physical activity level, quality of life, breathlessness questionnaires. In addition, blood sampling and body measurements will be completed. The investigators will also measure arterial stiffness with a non-invasive technique. Arterial stiffness is a hardening of the artery wall. In a subgroup study, 20 participants will have additional visits and measures. The investigators will be doing magnetic resonance imaging (MRI), diagnostic pictures of the inside of the body which is used for picturing the fat tissue around the abdomen. The investigators will be also doing a postprandial lipaemic test which is testing the fat level in the circulating blood after a high-fat meal. The investigators will do this test as before and after the intervention to allow for comparison.

Official Title
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The Effectiveness of a Physical Activity Intervention Versus Pulmonary Rehabilitation on Cardiovascular Risk Markers for Individuals With Chronic Obstructive Pulmonary Disease: a Feasibility Study

Conditions
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Cardiovascular Diseases, Cardiovascular Risk Factor, COPD

Intervention / Treatment
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* Behavioral: Physical activity intervention
* Other: Pulmonary rehabilitation group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study Male or Female, aged 40 years to 85 years. Diagnosed with COPD Able (in the Investigators opinion) and willing to comply with all study requirements. Participant is willing to attend visits at baseline and 8 weeks (sub-group: baseline, 8 weeks) Able to read and understand English Exclusion Criteria: Age <40 Attended a pulmonary rehabilitation programme or participating in a physical activity intervention study in current time or in the last 6 months. Any other significant diseases or disorders that are a contraindication to be enrolled in a pulmonary rehabilitation programme.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A feasibility study with three groups. two interventional groups and one control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>Physical activity group will be given a FitBit device to monitor their PA, especially steps count Step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home based intervention. | Behavioral: Physical activity intervention<br>* Physical activity group will be given a charge 2 FitBit device to monitor their PA specially steps count, step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home-based intervention.<br>|
| Experimental: Pulmonary rehabilitation group<br>Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013) | Other: Pulmonary rehabilitation group<br>* Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)<br>* Other names: Exercise intervention;|
| No Intervention: Usual care<br>Usual care group will have the standard follow up care by rehabilitation clinic without being in any physical intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference | Waist circumference will be determined at the narrowest part of the torso above the umbilicus and below the xiphoid process using a measuring tape before and after the intervention. | Change from baseline waist circumference at 8 weeks. | 
| Body fat percentage | Body fat in percentage will be measured in %BF using bioelectrical impedance analysis before and after the intervention. | Change from baseline body fat percentage at 8 weeks. | 
| Fasted triglyceride concentration | A fasted blood sample will be drawn to measure triglyceride concentrations before and after the intervention. | Change from baseline fasted triglyceride concentration at 8 weeks. | 
| Fasted total cholesterol concentration | A fasted blood sample will be drawn to measure total cholesterol concentrations before and after the intervention. | Change from baseline fasted total cholesterol concentration at 8 weeks. | 
| Fasted high-density lipoprotein cholesterol concentration | A fasted blood sample will be drawn to measure high-density lipoprotein cholesterol concentrations before and after the intervention. | Change from baseline fasted high-density lipoprotein cholesterol concentration at 8 weeks. | 
| Fasted low-density lipoprotein cholesterol concentration | A fasted blood sample will be drawn to measure low-density lipoprotein cholesterol concentrations before and after the intervention. | Change from baseline fasted low-density lipoprotein cholesterol concentration at 8 weeks. | 
| Fasted C-reactive protein concentration | A fasted blood sample will be drawn to measure C-reactive protein concentrations before and after the intervention. | Change from baseline fasted C-reactive protein concentration at 8 weeks. | 
| Fasted insulin concentration | A fasted blood sample will be drawn to measure insulin concentrations before and after the intervention. | Change from baseline fasted insulin concentration at 8 weeks. | 
| Fasted glucose concentration | A fasted blood sample will be drawn to measure glucose concentrations before and after the intervention. | Change from baseline fasted glucose concentration at 8 weeks. | 
| Arterial stiffness | 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. | Change from baseline arterial stiffness at 8 weeks. | 
| QRISK2 questionnaire | QRISK2 is a cardiovascular disease (CVD) risk score which is designed to estimate the risk of a person developing CVD over the next 10 years. This will be assessed using a short questionnaire before and after the intervention. | Change from baseline QRISK2 questionnaire at 8 weeks. | 
| Weight | Weight in kilograms will be measured using an electronic measuring station before and after the intervention. | Change from baseline weight at 8 weeks. | 
| Body mass index | Height in cm and weight in kilograms will be measured and combined to calculate body mass index in kg/m^2 before and after the intervention. | Change from baseline body mass index at 8 weeks. | 
| Medical Research Council dyspnoea scale | The Medical Research Council dyspnoea scale is a questionnaire that assesses how breathlessness affects COPD patient mobility. The questionnaire will be completed before and after the intervention. The scale range from 1 to 5. as 5 is the worse. | Change from baseline MRC dyspnoea scale at 8 weeks. | 
| Borg Breathlessness score | The Borg breathlessness scale is a questionnaire that assesses pateint breathlessness. The questionnaire will be completed before and after the intervention. The scale range is from 0 to 10 as 0 no difficulty in breathing and 10 is the maximum breathlessness score. | Change from baseline Borg breathlessness score at 8 weeks. | 
| Step counts per day | Physical activity level (step count per day) will be measured using an actigraph physical activity monitor. Participants will wear the device for one week on two occasions at week 1 (before the intervention) and week 8 (after the intervention). | Change from baseline step counts per day at 8 weeks. | 
| Chronic Respiratory Disease Questionnaire Self-Reported(CRQ-SR) | CRQ-SR is used to measure the health status of COPD patients. The questionnaire will be completed before and after the intervention. | Change from baseline CRQ-SR at 8 weeks. | 
| Bristol COPD Knowledge Questionnaire (BCKQ) | BCKQ is a questionnaire that is used to assess the knowledge that is appropriate for COPD patients. The questionnaire will be completed before and after the intervention. | Change from baseline BCKQ at 8 weeks. | 
| COPD Assessment Test (CAT) Questionnaire | The CAT questionnaire it is designed to measure the impact of COPD on a person's life. The questionnaire will be completed before and after the intervention. | Change from baseline CAT at 8 weeks. | 
| Hospital Anxiety and Depression Scale (HADS) | HADS is a self-rating scale that measures anxiety and depression. The questionnaire will be completed before and after the intervention. The scale score range from 0 to 21. 0-7 considered normal, 8 to 10 is considered borderline abnormal and 11 to 21 is considered abnormal. | Change from baseline HADS at 8 weeks. | 
| Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE) | PRAISE is a tool that predicts the reduction in sedentary time following pulmonary rehabilitation in individuals with chronic obstructive pulmonary disease (COPD). UIt will be completed before and after the intervention. | Change from baseline PRAISE at 8 weeks. | 
| The Incremental Shuttle Walking Test (ISWT) | The Incremental Shuttle Walking Test (ISWT) in meters will be completed before and after the intervention to assess exercise capacity. | Change from baseline exercise capacity at 8 weeks. | 
| The endurance shuttle walk test (ESWT) | The endurance shuttle walk test (ESWT) in minutes will be completed before and after the intervention to assess exercise capacity. | Change from baseline exercise capacity at 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postprandial triglyceride concentrations (sub-group only) | Triglyceride concentrations will be 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. | Change from baseline postprandial triglyceride concentration at 8 weeks. | 
| Postprandial total cholesterol concentration (sub-group only) | Total cholesterol concentrations will be 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. | Change from baseline postprandial total cholesterol concentration at 8 weeks. | 
| Postprandial high-density lipoprotein cholesterol concentration (sub-group only) | High-density lipoprotein cholesterol concentrations will be 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. | Change from baseline postprandial high-density lipoprotein concentration level at 8 weeks. | 
| Postprandial low-density lipoprotein cholesterol concentration (sub-group only) | Low density lipoprotein cholesterol concentrations will be 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. | Change from baseline postprandial low-density lipoprotein cholesterol concentration at 8 weeks. | 
| Postprandial total C-reactive protein concentration (sub-group only) | C-reactive protein concentrations will be 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. | Change from baseline postprandial C-reactive protein concentration at 8 weeks. | 
| Postprandial total insulin concentration (sub-group only) | insulin concentrations will be 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. | Change from baseline postprandial insulin concentration at 8 weeks. | 
| Postprandial total glucose concentration (sub-group only) | Glucose concentrations will be 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. | Change from baseline postprandial glucose concentration at 8 weeks. | 
| Visceral adipose tissue | Visceral adipose tissue will be quantified before the intervention using magnetic resonance imaging (MRI). | Baseline visceral adipose tissue | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Physical activity, pulmonary rehabilitation, COPD physical activity level, COPD comorbidities