Physical Activity Intervention and Cardiovascular Risk Markers in COPD

NCT03869112 | Unknown

• 1 other identifier: 18/EM/0270
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; COPD

Keywords

COPD; Physical activity; pulmonary rehabilitation; COPD physical activity level; COPD comorbidities

Outcome Measures

Primary Outcomes (23)

• 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 Outcomes (8)

• Postprandial triglyceride concentrations (sub-group only)

  Change from baseline postprandial triglyceride concentration at 8 weeks.

• Postprandial total cholesterol concentration (sub-group only)

  Change from baseline postprandial total cholesterol concentration at 8 weeks.

• Postprandial high-density lipoprotein cholesterol concentration (sub-group only)

  Change from baseline postprandial high-density lipoprotein concentration level at 8 weeks.

• Postprandial low-density lipoprotein cholesterol concentration (sub-group only)

  Change from baseline postprandial low-density lipoprotein cholesterol concentration at 8 weeks.

• Postprandial total C-reactive protein concentration (sub-group only)

  Change from baseline postprandial C-reactive protein concentration at 8 weeks.

Study Arms (3)

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.

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)

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.

Interventions

Physical activity intervention BEHAVIORAL

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.

Physical activity intervention

Pulmonary rehabilitation group OTHER

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)

Also known as: Exercise intervention

Pulmonary rehabilitation group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals, Leicester: lead
• Loughborough University: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE3 9QP, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 22470299 BACKGROUND

• 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.

  PMID: 24558112 BACKGROUND

• 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.

  PMID: 27081189 BACKGROUND

• 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.

  PMID: 23474622 BACKGROUND

Related Links

• 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). . 2017

MeSH Terms

Conditions

Cardiovascular Diseases; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Sally Singh, Professor

  University Hospital of Leicester NHS Tust

  STUDY CHAIR

Central Study Contacts

Tareq Alotaibi, PhD student

CONTACT

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

David Stensel, Professor

CONTACT

+44(0)1509 226344; D.J.Stensel@lboro.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A feasibility study with three groups. two interventional groups and one control.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 11, 2019
• Study Start: April 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)