Cardiovascular DiseasesPARCNCT03869112
Physical Activity Intervention and Cardiovascular Risk Markers in COPD
A study testing Physical activity intervention and Pulmonary rehabilitation group in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiovascular Risk Factor, COPD
- What is being tested?
- Physical activity intervention and Pulmonary rehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE3 9QP
Sally Singh, Professor, 0116 250 2350, sally.singh@uhl-tr.nhs.uk
David Stensel, Professor, +44(0)1509 226344, D.J.Stensel@lboro.ac.uk
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, COPD
- Being tested
- Physical activity intervention, Pulmonary rehabilitation group
- Keywords
- COPD, Physical activity, pulmonary rehabilitation, COPD physical activity level, COPD comorbidities
- Medical subject headings
- Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
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.
Pulmonary rehabilitation groupOther
Also called Exercise intervention
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)
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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. Receives: Behavioral: Physical activity intervention |
| Pulmonary rehabilitation group | Experimental | 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) Receives: Other: Pulmonary rehabilitation group |
| Usual care | No intervention | Usual care group will have the standard follow up care by rehabilitation clinic without being in any physical intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline exercise capacity at 8 weeks.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline visceral adipose tissue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A feasibility study with three groups. two interventional groups and one control.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Loughborough University
- Responsible party
- Principal investigator, Tareq Alotaibi, University Hospitals, Leicester
- Investigators
- Sally Singh, Professor, Study chair, University Hospital of Leicester NHS Tust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869112
- Sponsor's protocol ID
- 18/EM/0270
- Acronym
- PARC
- Status last verified
- Mar 2019
- First submitted
- 26 Feb 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22470299Gimeno-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.
PubMed 24558112Triest 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.
PubMed 27081189Shortreed 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.
PubMed 23474622
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03869112
- Acronym / sponsor ID
- PARC / 18/EM/0270
- Conditions
- Cardiovascular Diseases, Cardiovascular Risk Factor, COPD
- Keywords
- COPD, Physical activity, pulmonary rehabilitation, COPD physical activity level, COPD comorbidities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- Loughborough University
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A feasibility study with three groups. two interventional groups and one control.
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionPhysical 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. |
| Pulmonary rehabilitation group | Experimental | Other: Pulmonary rehabilitation groupPulmonary 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) |
| Usual care | No intervention | –Usual care group will have the standard follow up care by rehabilitation clinic without being in any physical intervention. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity interventionPhysical 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. | Behavioural | Physical activity intervention |
| Pulmonary rehabilitation groupAlso: Exercise interventionPulmonary 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 |
Primary outcome
Waist circumference
Time frame: Change from baseline waist circumference at 8 weeks.
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.
Body fat percentage
Time frame: Change from baseline body fat percentage at 8 weeks.
Body fat in percentage will be measured in %BF using bioelectrical impedance analysis before and after the intervention.
Fasted triglyceride concentration
Time frame: Change from baseline fasted triglyceride concentration at 8 weeks.
A fasted blood sample will be drawn to measure triglyceride concentrations before and after the intervention.
Fasted total cholesterol concentration
Time frame: Change from baseline fasted total cholesterol concentration at 8 weeks.
A fasted blood sample will be drawn to measure total cholesterol concentrations before and after the intervention.
Fasted high-density lipoprotein cholesterol concentration
Time frame: Change from baseline fasted high-density lipoprotein cholesterol concentration at 8 weeks.
A fasted blood sample will be drawn to measure high-density lipoprotein cholesterol concentrations before and after the intervention.
Fasted low-density lipoprotein cholesterol concentration
Time frame: Change from baseline fasted low-density lipoprotein cholesterol concentration at 8 weeks.
A fasted blood sample will be drawn to measure low-density lipoprotein cholesterol concentrations before and after the intervention.
Fasted C-reactive protein concentration
Time frame: Change from baseline fasted C-reactive protein concentration at 8 weeks.
A fasted blood sample will be drawn to measure C-reactive protein concentrations before and after the intervention.
Fasted insulin concentration
Time frame: Change from baseline fasted insulin concentration at 8 weeks.
A fasted blood sample will be drawn to measure insulin concentrations before and after the intervention.
Fasted glucose concentration
Time frame: Change from baseline fasted glucose concentration at 8 weeks.
A fasted blood sample will be drawn to measure glucose concentrations before and after the intervention.
Arterial stiffness
Time frame: Change from baseline arterial stiffness at 8 weeks.
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.
QRISK2 questionnaire
Time frame: Change from baseline QRISK2 questionnaire at 8 weeks.
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.
Weight
Time frame: Change from baseline weight at 8 weeks.
Weight in kilograms will be measured using an electronic measuring station before and after the intervention.
Body mass index
Time frame: Change from baseline body mass index at 8 weeks.
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.
Medical Research Council dyspnoea scale
Time frame: Change from baseline MRC dyspnoea scale at 8 weeks.
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.
Borg Breathlessness score
Time frame: Change from baseline Borg breathlessness score at 8 weeks.
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.
Step counts per day
Time frame: Change from baseline step counts per day at 8 weeks.
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).
Chronic Respiratory Disease Questionnaire Self-Reported(CRQ-SR)
Time frame: Change from baseline CRQ-SR at 8 weeks.
CRQ-SR is used to measure the health status of COPD patients. The questionnaire will be completed before and after the intervention.
Bristol COPD Knowledge Questionnaire (BCKQ)
Time frame: Change from baseline BCKQ at 8 weeks.
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.
COPD Assessment Test (CAT) Questionnaire
Time frame: Change from baseline CAT at 8 weeks.
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.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from baseline HADS at 8 weeks.
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.
Pulmonary Rehabilitation Adapted Index of Self-Efficacy (PRAISE)
Time frame: Change from baseline PRAISE at 8 weeks.
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.
The Incremental Shuttle Walking Test (ISWT)
Time frame: Change from baseline exercise capacity at 8 weeks.
The Incremental Shuttle Walking Test (ISWT) in meters will be completed before and after the intervention to assess exercise capacity.
The endurance shuttle walk test (ESWT)
Time frame: Change from baseline exercise capacity at 8 weeks.
The endurance shuttle walk test (ESWT) in minutes will be completed before and after the intervention to assess exercise capacity.
8 secondary outcomes
Postprandial triglyceride concentrations (sub-group only)
Time frame: Change from baseline postprandial triglyceride concentration at 8 weeks.
Postprandial total cholesterol concentration (sub-group only)
Time frame: Change from baseline postprandial total cholesterol concentration at 8 weeks.
Postprandial high-density lipoprotein cholesterol concentration (sub-group only)
Time frame: Change from baseline postprandial high-density lipoprotein concentration level at 8 weeks.
Postprandial low-density lipoprotein cholesterol concentration (sub-group only)
Time frame: Change from baseline postprandial low-density lipoprotein cholesterol concentration at 8 weeks.
Postprandial total C-reactive protein concentration (sub-group only)
Time frame: Change from baseline postprandial C-reactive protein concentration at 8 weeks.
Postprandial total insulin concentration (sub-group only)
Time frame: Change from baseline postprandial insulin concentration at 8 weeks.
Postprandial total glucose concentration (sub-group only)
Time frame: Change from baseline postprandial glucose concentration at 8 weeks.
Visceral adipose tissue
Time frame: Baseline visceral adipose tissue
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 22470299Li 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.
- Background: PubMed 24558112Gimeno-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.
- Background: PubMed 27081189Triest 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.
- Background: PubMed 23474622Shortreed 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.
- Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). . 2017Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally Singh, Professor study chair
University Hospital of Leicester NHS Tust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention and Pulmonary rehabilitation group in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tareq Alotaibi, PhD student (+44(0)1509 226344, T.alotaibi@lboro.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: Change from baseline waist circumference at 8 weeks.). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03869112, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.