Physical Activity Intervention and Cardiovascular Risk Markers in COPD (PARC)

NHS Trust

Status: Unknown

Conditions: Cardiovascular Diseases; COPD; Cardiovascular Risk Factor

Treatments: Other: Pulmonary rehabilitation group; Behavioral: Physical activity intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03869112

18/EM/0270

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Physical activity intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Physical activity intervention

Pulmonary rehabilitation group

Experimental group

Description:

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)

Treatment:

Other: Pulmonary rehabilitation group

Usual care

No Intervention group

Description:

Usual care group will have the standard follow up care by rehabilitation clinic without being in any physical intervention.