A centre for progressive clinical research
Research at Atrium Health
In addition to being a centre for clinical rehabilitation, Atrium is a hub for translational research.
At the heart of Atrium Health is a culture of applied clinical research with many staff involved in local, national and international research projects.
Atrium co-ordinates and delivers clinical research for numerous academic partners in addition to undertaking their own clinical trials led by Stuart Ennis and Gordon McGregor.
A multitude of research projects are underway at Atrium Health, Centre for Exercise & Health. Clinical academics Gordon McGregor (Coventry University) and Stuart Ennis (Cardiff Metropolitan University) head-up a wide-ranging clinical research portfolio.
Mr Stuart Ennis
Dr Gordon McGregor
Mr Richard Powell
High Intensity Interval Training In pATiEnts with intermittent claudication (INITIATE): a proof-of-concept prospective cohort study to assess acceptability, feasibility and potential clinical efficacy
Arterial disease in the legs is a common condition affecting 5-10% of the population over 60 years old. Fatty deposits build up in the arteries restricting blood supply to leg muscles, causing pain when walking which severely limits walking ability and quality of life. The medical term for this is “intermittent claudication” (IC). Clinical trials have shown that supervised exercise programmes significantly improve patients’ symptoms, walking distances and quality of life. The NHS and the National Institute of Health and Care Excellence recommend these exercise programmes (at least 2 hours per week for 3 months) as first line treatment for intermittent claudication.
However, although we know exercise programmes work, they are not popular with patients. Only 24% of patients
who are offered exercise therapy will actually start the programme. The most common reason patients cite for
declining is that the programmes are too time consuming
Recent research, mainly in heart disease patients, suggests a new type of “high intensity” exercise programme, may be just as effective but more appealing to patients, potentially increasing the number of patients taking up exercise programmes. This is because “high intensity” programmes have both shorter exercise class times (20 minutes) and total programme duration (6 weeks). “High intensity” exercise involves alternating repeated short ‘bursts’ of hard exercise with easy exercise or recovery.
This study will assess whether “high intensity” exercise programmes in patients with claudication are
– safe and well tolerated
– effective in improving symptoms, fitness and quality of life
– are appealing and improve uptake rates
Forty patients with intermittent claudication will undertake a 20 minute “high intensity” exercise session, 3
times / week, for 6 weeks, using a static bicycle at the 2 NHS hospitals. We will measure
– adverse effects of the programme, how easy or hard patients find the exercise programme, and whether patients
can achieve the intended exercise intensity by measuring heart rate
– effectiveness of the programme using treadmill walking tests and questionnaires assessing patients’ symptoms
and general health related quality of life, before and after the “high intensity” programme
– the appeal of the “high intensity” programme using uptake / completion rates and patient views and opinions at interview.
Supervised Pulmonary Hypertension Exercise Rehabilitation (SPHERe) trial
Why is this important?
Pulmonary hypertension is a disabling long-term condition that can greatly reduce quality of life. Blood vessels supplying the lungs become thick and stiff, restricting blood flow. Blood pressure is increased in these vessels meaning the heart must work harder to pump blood to the lungs. Over time, the heart may begin to fail. Breathlessness, fatigue and dizziness are the most common symptoms. People with pulmonary hypertension are often anxious about carrying out normal daily activities. There are five types of pulmonary hypertension with different causes. Medical treatment is different for each type, and may help to improve symptoms. Little is known about whether exercise rehabilitation may help people living with pulmonary hypertension. Supervised exercise rehabilitation is a common treatment for many heart and lung conditions. It can improve fitness, breathlessness, anxiety, depression, and quality of life. Some research has shown that exercise rehabilitation may be helpful for people with certain types of pulmonary hypertension: pulmonary arterial hypertension, and pulmonary hypertension due to blood clots in the lungs. Most of these exercise programmes included three weeks of intensive exercise as a hospital in-patient. This is not feasible in the NHS, where exercise rehabilitation is an out-patient service, typically lasting an hour, twice a week for eight weeks. We do not know if out-patient exercise rehabilitation can help improve the lives of people with pulmonary hypertension.
What are we trying to find out?
We want to know if out-patient exercise rehabilitation, combined with psychological and motivational support, can improve fitness and quality of life for people living with pulmonary hypertension. We are particularly interested in people whose pulmonary hypertension is secondary to heart or lung disease, because exercise rehabilitation has not been researched in these groups. We will enrol 350 people with pulmonary hypertension who live near one of 11 rehabilitation centres in the East and West Midlands, and who agree to be randomly allocated to supervised exercise with psychological and motivational support, or to continue with usual care (general physical activity advice).
What treatments are we testing?
The intervention group will be invited to complete eight weeks of twice-weekly supervised out-patient exercise rehabilitation. We have developed an exercise programme suitable for people with all types of pulmonary hypertension that can be delivered within existing NHS exercise rehabilitation services. We have tested, evaluated, and refined this over a six-month period. The study will be run in specialist rehabilitation centres by staff experienced in treating people with heart and lung problems. Psychological and motivational support will help reduce anxiety and improve exercise adherence. People in the usual care group will receive general physical activity advice, but not supervised exercise.
How will we know if the treatment helps?
From talking to people with pulmonary hypertension, we know that the most important benefit of any treatment is reduced breathlessness and fatigue. People have told us that this would reduce anxiety about daily activities, helping them to ‘do more’, walk further and have a better quality of life. We will use a walking test and quality of life questionnaires over one year to measure if our intervention helps people with pulmonary hypertension, and represents good value for the NHS.
PostUraL tachycardia Syndrome Exercise
An active living intervention designed by people with POTS, for people with POTS
Postural Orthostatic Tachycardia Syndrome (POTS) can seriously effect well-being and quality of life, due to its many disabling symptoms. The condition mostly (but not only) affects women aged 13 to 50. People with POTS have an abnormal heart rate rise when they stand up, with symptoms including palpitations, dizziness, fainting, and long-lasting fatigue.
Attending education, earning a living, and caring for dependants can be severely affected, and the impact on the healthcare system is significant.
Medical treatment is not always effective for POTS, but active living interventions like exercise may help some people. We aim to find out if people with POTS will enrol on, and complete, a supervised exercise programme. First, we will run discussion groups with people affected by POTS, to help us better understand their needs, and refine an exercise intervention.
At two hospitals, we will then invite people with POTS onto a study comparing a supervised exercise and motivational support intervention, with usual care (no supervised exercise). We will test whether people want to be involved, can tolerate the exercise, and if symptoms and quality of life improve over time.
Projects delivered at Atrium Health primarily assess the acute and chronic physiological and psychosocial effects of exercise and physical activity in clinical populations. We run both observational studies and clinical trials.
Facilities, equipment and capability include:
- Fully equipped gym and exercise studio
- Functional fitness studio
- Clinic rooms and research laboratory
- Cardiopulmonary exercise testing
- Submaximal functional capacity exercise testing
- Cardiac ultrasound (echocardiography)
- Biochemistry – centrifuge and frozen sample storage
- Isometric leg strength dynamometry
- Peripheral arterial tonometry
- Laser Doppler vascular function
Research trials and Publications
Investigating the acute physiological response to exercise in end stage renal disease – from theory to practice (PRECISE)
Chronic kidney disease (CKD) affects between 5-10% of the world’s population, equating to ~740 million people worldwide. End stage renal disease (ESRD) is the result of a progressive loss of kidney function where the patient requires dialysis to replace the typical functions of the kidney.
The quality of life of these individuals can be poor as a result of various complications associated with CKD (e.g. heart disease, diabetes, muscle wastage, decreased fitness).
In an attempt to combat reduced physical fitness, many studies have applied long term exercise programmes. However, the body’s response to exercise in people with CKD is not well understood and a set of guidelines that informs safe and effective exercise prescription is lacking.
In patients with ESRD, this study aims to characterise the acute physiological response to exercise under different conditions. In doing so, the study aims to inform the development of guidelines for safe and effective intra-dialytic exercise training.
Link to paper- https://www.hindawi.com/journals/bmri/2018/8276912/
Link to clinical trials- https://clinicaltrials.gov/ct2/show/NCT03064555?term=PRECISE&cntry=GB&draw=1&rank=1
Contact- Scott McGuire
Early cardiac rehabilitation exercise training in patients with sternotomy (SCAR): a randomised controlled trial and economic evaluation.
Current guidelines recommend abstinence from supervised cardiac rehabilitation (CR) exercise training for 6 weeks post-sternotomy.
This practice is not based on empirical evidence, thus imposing potentially unnecessary activity restrictions. The purpose of this trial is to compare CR exercise training commenced early (2 weeks post-surgery) with current usual care (6 weeks post-surgery) with a view to informing future CR guidelines for patients recovering from sternotomy.
Methods and analysis-
140 cardiac surgery patients, recovering from sternotomy, will be assigned to 8 weeks of twice-weekly supervised CR exercise training commencing at either 2 weeks (early CR) or 6 weeks (usual care CR) post-surgery. Usual care exercise training will adhere to current UK recommendations. Participants in the early CR group will undertake a highly individualised 2–3 week programme of functional mobility, strength and cardiovascular exercise before progressing to a usual care CR programme.
Outcomes will be assessed at baseline (inpatient), pre-CR (2 or 6 weeks post-surgery), post-CR (10 or 14 weeks post-surgery) and 12 months. The primary outcome will be change in 6 min walk distance. Secondary outcomes will include measures of functional fitness, quality of life and cost-effectiveness.
Link to paper- https://bmjopen.bmj.com/content/8/3/e019748
Link to clinical trials- https://clinicaltrials.gov/ct2/show/NCT03223558
Contact- Stuart Ennis
High intensity interval training versus moderate intensity steady state training in UK cardiac rehabilitation programmes (HIIT or MISS UK): a multi-centre randomised controlled trial and economic evaluation.
Current international guidelines for cardiac rehabilitation (CR) advocate moderate-intensity exercise training (MISS, moderate-intensity steady state).
High-intensity interval training (HIIT) appears to be a safe and effective alternative, resulting in greater improvements in exercise capacity.
The purpose of this multicentre randomised controlled trial is to compare the effects of HIIT and MISS training in patients with Coronary Heart Disease (CHD) attending UK CR programmes.
Methods and analysis-
This pragmatic study will randomly allocate 510 patients with CHD to 8 weeks of twice weekly HIIT or MISS training at 3 centres in the UK.
Outcome measures will be assessed at baseline, 8 weeks and 12 months. The primary outcome for the trial will be change in exercise capacity. Secondary measures will assess physiological, psychosocial and economic outcomes.
Link to paper- http://bmjopen.bmj.com/content/6/11/e012843
Link to clinical trials- https://clinicaltrials.gov/ct2/show/NCT02784873
Contact- Dr Gordon McGregor or Richard Powell
The heart failure with preserved ejection fraction pathophysiology study (IDENTIFY-HFpEF)
Does increased arterial stiffness additionally to related to ageing, coupled with vascular effects of comorbidities, associate with HFpEF?
There has been a paradigm shift proposing that comorbidities are a major contributor towards the heart failure with preserved ejection fraction (HFpEF) syndrome. Furthermore, HFpEF patients have abnormal macro and microvascular function, which may significantly contribute towards altered ventriculo-vascular coupling in these patients.
The IDENTIFY-HF study is an observational study that investigates whether gradually increasing arterial stiffness (in addition to ageing) as a result of increasing common comorbidities, such as hypertension and diabetes, is associated with HFpEF.
Protocol paper yet to be published
Link to clinical trials- https://clinicaltrials.gov/ct2/show/NCT03186833
Contact- Dr Danish Ali
Enhanced psychological care in cardiac rehabilitation services for patients with new onset depressive symptoms compared with treatment as usual: The CADENCE Study.
The CADENCE study aims to develop and assess the feasibility and acceptability of an enhanced psychological care (EPC) intervention within cardiac rehabilitation services for patients with new-onset depressive symptoms, compared to treatment as usual.
The study will consist of two phases – a feasibility study and a pilot cluster randomised controlled trial (RCT).
A mixed methods approach will be used to assess the feasibility and acceptability of the EPC intervention to NHS cardiac rehabilitation nurses and to patients who experience depressive symptoms following an acute cardiac event.
This will include documenting ‘process information’ (e.g. patient flow through cardiac rehabilitation services and numbers of patients eligible for and recruited into the study), describing the socio-demographic characteristics of participating patients, conducting in-depth interviews with cardiac rehabilitation nurses and patients, and observing the delivery of EPC within participating cardiac rehabilitation services.
Link to trial information- http://medicine.exeter.ac.uk/research/healthresearch/primarycare/projects/cadence/
Kidney disease mediated cardiac and skeletal muscle impairment: effects of dynamic exercise training and low frequency electrical muscle stimulation during haemodialysis; a pilot study
The effects of low frequency electrical muscle stimulation in chronic heart failure; a randomised feasibility trial
Link to paper- https://bmjopen.bmj.com/content/7/8/e016148
The development and pilot trial of two programmes of rehabilitation for cancer patients (PRO-REHAB)
Link to clinical trials- http://www.isrctn.com/ISRCTN14861313
Physical activity programmes for community dwelling people with mild to moderate dementia (DAPA – Dementia And Physical Activity)
Link to clinical trials- http://www.isrctn.com/ISRCTN32612072
Is exercise-based cardiac rehabilitation effective? A systematic review and meta-analysis to re-examine the evidence
Link to paper- https://bmjopen.bmj.com/content/8/3/e019656
Exercise rehabilitation programmes for pulmonary hypertension: a systematic review of intervention components and reporting quality
Link to paper- https://bmjopensem.bmj.com/content/4/1/e000400
The effects of cardiac rehabilitation exercise training on left ventricular remodelling in post-myocardial infarction patients
Improving the accuracy of cardiovascular risk assessments delivered in community practice for high-risk patient groups. A tailored, cognitive behavioural approach intervention for mild to moderate anxiety and/or depression in people with chronic obstructive pulmonary disease
(TANDEM): A randomised controlled trial.
Atrium Health has been providing rehabilitation for vascular patients after donation from the Circulation foundation. Monies received came from 2 charitable trusts (Garfield Weston and James Tudor).
Atrium have hosted several research studies in collaboration with Warwick University and continue to plan future research bids at the Warwick Medical School and Clinical Trials Unit (CTU).
Cardiff Metropolitan University
Two Atrium Directors, Gordon McGregor and Stuart Ennis, have completed their Doctorates at The Welsh University. They continue to collaborate with Atrium Health on current research studies.