UnknownNot Applicable

Physical Activity Intervention and Cardiovascular Risk Markers in COPD

United Kingdom60 participantsStarted 2019-04-01

Plain-language 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.

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Waist circumference

Timeframe: Change from baseline waist circumference at 8 weeks.

Body fat percentage

Timeframe: Change from baseline body fat percentage at 8 weeks.

Fasted triglyceride concentration

Timeframe: Change from baseline fasted triglyceride concentration at 8 weeks.

Fasted total cholesterol concentration

Timeframe: Change from baseline fasted total cholesterol concentration at 8 weeks.

Fasted high-density lipoprotein cholesterol concentration

Timeframe: Change from baseline fasted high-density lipoprotein cholesterol concentration at 8 weeks.

Fasted low-density lipoprotein cholesterol concentration

Timeframe: Change from baseline fasted low-density lipoprotein cholesterol concentration at 8 weeks.

Fasted C-reactive protein concentration

Timeframe: Change from baseline fasted C-reactive protein concentration at 8 weeks.

Trial details

NCT IDNCT03869112

SponsorUniversity Hospitals, Leicester

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-01

Contact for this trial

Tareq Alotaibi, PhD student

+44(0)1509 226344 T.alotaibi@lboro.ac.uk

View on ClinicalTrials.gov More Cardiovascular Diseases trials