Clinical trial NCT03869112: Physical Activity Intervention and Cardiovascular Risk Markers in COPD
Official title: The Effectiveness of a Physical Activity Intervention Versus Pulmonary Rehabilitation on Cardiovascular Risk Markers for Individuals With Chronic Obstructive Pulmonary Disease: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Cardiovascular Risk Factor
COPD
Keywords: COPD
Physical activity
pulmonary rehabilitation
COPD physical activity level
COPD comorbidities
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
Collaborators: name: Loughborough University
First posted: 2019-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A feasibility study with three groups. two interventional groups and one control.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Waist circumference
timeFrame: Change from baseline waist circumference at 8 weeks.
measure: Body fat percentage
timeFrame: Change from baseline body fat percentage at 8 weeks.
measure: Fasted triglyceride concentration
timeFrame: Change from baseline fasted triglyceride concentration at 8 weeks.
measure: Fasted total cholesterol concentration
timeFrame: Change from baseline fasted total cholesterol concentration at 8 weeks.
measure: Fasted high-density lipoprotein cholesterol concentration
timeFrame: Change from baseline fasted high-density lipoprotein cholesterol concentration at 8 weeks.
measure: Fasted low-density lipoprotein cholesterol concentration
timeFrame: Change from baseline fasted low-density lipoprotein cholesterol concentration at 8 weeks.
measure: Fasted C-reactive protein concentration
timeFrame: Change from baseline fasted C-reactive protein concentration at 8 weeks.
measure: Fasted insulin concentration
timeFrame: Change from baseline fasted insulin concentration at 8 weeks.
measure: Fasted glucose concentration
timeFrame: Change from baseline fasted glucose concentration at 8 weeks.
measure: Arterial stiffness
timeFrame: Change from baseline arterial stiffness at 8 weeks.
measure: QRISK2 questionnaire
timeFrame: Change from baseline QRISK2 questionnaire at 8 weeks.
measure: Weight
timeFrame: Change from baseline weight at 8 weeks.
measure: Body mass index
timeFrame: Change from baseline body mass index at 8 weeks.
measure: Medical Research Council dyspnoea scale
timeFrame: Change from baseline MRC dyspnoea scale at 8 weeks.
measure: Borg Breathlessness score
timeFrame: Change from baseline Borg breathlessness score at 8 weeks.
measure: Step counts per day
timeFrame: Change from baseline step counts per day at 8 weeks.
measure: Chronic Respiratory Disease Questionnaire Self-Reported(CRQ-SR)
timeFrame: Change from baseline CRQ-SR at 8 weeks.
measure: Bristol COPD Knowledge Questionnaire (BCKQ)
timeFrame: Change from baseline BCKQ at 8 weeks.
measure: COPD Assessment Test (CAT) Questionnaire
timeFrame: Change from baseline CAT at 8 weeks.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline HADS at 8 weeks.
measure: Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE)
timeFrame: Change from baseline PRAISE at 8 weeks.
measure: The Incremental Shuttle Walking Test (ISWT)
timeFrame: Change from baseline exercise capacity at 8 weeks.
measure: The endurance shuttle walk test (ESWT)
timeFrame: Change from baseline exercise capacity at 8 weeks.
Secondary outcomes:
measure: Postprandial triglyceride concentrations (sub-group only)
timeFrame: Change from baseline postprandial triglyceride concentration at 8 weeks.
measure: Postprandial total cholesterol concentration (sub-group only)
timeFrame: Change from baseline postprandial total cholesterol concentration at 8 weeks.
measure: Postprandial high-density lipoprotein cholesterol concentration (sub-group only)
timeFrame: Change from baseline postprandial high-density lipoprotein concentration level at 8 weeks.
measure: Postprandial low-density lipoprotein cholesterol concentration (sub-group only)
timeFrame: Change from baseline postprandial low-density lipoprotein cholesterol concentration at 8 weeks.
measure: Postprandial total C-reactive protein concentration (sub-group only)
timeFrame: Change from baseline postprandial C-reactive protein concentration at 8 weeks.
measure: Postprandial total insulin concentration (sub-group only)
timeFrame: Change from baseline postprandial insulin concentration at 8 weeks.
measure: Postprandial total glucose concentration (sub-group only)
timeFrame: Change from baseline postprandial glucose concentration at 8 weeks.
measure: Visceral adipose tissue
timeFrame: Baseline visceral adipose tissue
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
state: Leicestershire
Study officials:
affiliation: University Hospital of Leicester NHS Tust
name: Sally Singh, Professor
role: STUDY_CHAIR
References:
citation: Li J, Siegrist J. Physical activity and risk of cardiovascular disease--a meta-analysis of prospective cohort studies. Int J Environ Res Public Health. 2012 Feb;9(2):391-407. doi: 10.3390/ijerph9020391. Epub 2012 Jan 26.
citation: Gimeno-Santos E, Frei A, Steurer-Stey C, de Batlle J, Rabinovich RA, Raste Y, Hopkinson NS, Polkey MI, van Remoortel H, Troosters T, Kulich K, Karlsson N, Puhan MA, Garcia-Aymerich J; PROactive consortium. Determinants and outcomes of physical activity in patients with COPD: a systematic review. Thorax. 2014 Aug;69(8):731-9. doi: 10.1136/thoraxjnl-2013-204763. Epub 2014 Feb 20.
citation: Triest FJ, Singh SJ, Vanfleteren LE. Cardiovascular risk, chronic obstructive pulmonary disease and pulmonary rehabilitation: Can we learn from cardiac rehabilitation? Chron Respir Dis. 2016 Aug;13(3):286-94. doi: 10.1177/1479972316642367. Epub 2016 Apr 14.
citation: Shortreed SM, Peeters A, Forbes AB. Estimating the effect of long-term physical activity on cardiovascular disease and mortality: evidence from the Framingham Heart Study. Heart. 2013 May;99(9):649-54. doi: 10.1136/heartjnl-2012-303461. Epub 2013 Mar 8.