Personalised Home-based Physical Activity Intervention in Older Adults With Heart Failure: Advancing Towards an Effective Clinical Therapy
Phase: NA
Conditions: Heart Failure, Systolic
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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Personalised home-based physical activity intervention in older adults with Heart 
Failure. 
 
Research Protocol  
Version 1.0 24th April 2015  
 
 
Research Team: 
Dr Djordje Jakovljevic (Senior Research Fellow, Newcastle University)  
Dr Jane Skinner (Consultant Cardiologist, RVI)  
Dr Kristian Bailey (Consultant Cardiologist, RVI) 
Dr Guy MacGowan (Consultant Cardiologist, Freeman Hospital) 
Dr Christopher Eggett (Cardiac Physiologist, RVI) 
Dr Sarah Moore (Physiotherapy Clinical Research Specialist, Newcastle University) 
Dr Leah Avery (Senior Researcher Associate, Newcastle University) 
            Dr Nicola O’Brien (Research Methodologist, Newcastle University) 
 
 

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Background 
 
Heart Failure (HF) is one of the most common forms of chronic heart condition and affects 
nearly 1 million people in the UK [1, 2]. The incidence and prevalence of HF have increased 
steeply as a result of (1) improved prognosis of coronary artery disease, (2) ageing of the 
population and (3) better medical treatments [3-5]. Aside from the obvious individual burden, 
HF also accounts for 1 million inpatient bed days - 2% of all NHS inpatient bed-days and 5% 
of all emergency medical admissions to hospital [2, 3]. It costs the NHS nearly 2% of its 
annual budget (around £625 million) [2, 3]. Hospital admissions because of HF are projected 
to rise by 50% over the next 25 years [2, 3].  
Evidence-based guidelines have been developed to improve diagnosis and treatment of HF 
[2, 6, 7]. These position physical activity and exercise therapy is a cornerstone of clinical 
management of Heart Failure. Evidence from meta-analyses shows that exercise improves 
functional capacity, quality of life, reduce symptom burden, reduce readmissions to hospital 
and improve survival in HF [8-11]. Exercise reverses the left ventricular remodelling and 
improves cardiac function at rest and during exercise [12-14]. Current guidelines from the 
UK, EU, and USA recommend exercise as an effective and safe intervention for HF 
(recommendation class I) [6, 7, 15].  
Despite the clear recommendations, only a small number of people affected by HF 
participate in cardiac rehabilitation [1]. Only 2% of people who participated in cardiac 
rehabilitation in the UK were referred because of heart failure [15]. Recent cross-national 
survey from England, Wales, and Northern Ireland reported that people with HF as a primary 
diagnosis are excluded from most cardiac rehabilitation programmes due to lack of 
resources and direct exclusion from local commissioning agreements [16]. In addition, a 
significant number of people do not accept the invitation to attend cardiac rehabilitation with 
the main reasons being difficulties in regularly attending centre-based cardiac rehabilitation 
sessions, work or domestic commitments and reluctance to take part in group-based classes 
[17] [18]. 
Home-based exercise cardiac rehabilitation programmes have been introduced in an attempt 
to widen access and participation as an alternative to supervised centre-based rehabilitation 
[19]. Home-based exercise programmes seem to be equally effective as centre based 
programmes in people with coronary artery disease i.e. following myocardial infarction and 
revascularisation [18-20]. It remains to be determined whether home-based exercise 
programmes deliver benefit to people with chronic HF. 

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Aim and Objectives: 
 
To design and evaluate a home-based physical activity intervention for adults with HF in 
order to improve participation in cardiac rehabilitation. This aim will be achieved through the 
following 3 objectives: (1) define current levels of physical activity and sedentary behaviour 
and their clinical correlates in HF, (2) co-design a personalised home-based physical activity 
intervention with patients, and (3) determine the effect of the home-based physical activity 
intervention. 
  
Methods/Design 
Design 
In order to design and evaluate a home-based physical activity intervention for older adults 
with heart failure, the research programme will have 2 research phases. 
Phase 1 – Qualitative Research using the Focus Group approach. Ten to fifteen older adults 
with chronic heart failure will take part in 3 focus groups to help identify i) views on 
performing home-based physical activity interventions, ii) potential barriers and facilitators to 
increasing physical activity levels; and iii) motivational incentives to increase and maintain 
appropriate physical activity level and introducing behavioural change. The focus groups will 
be conducted before, during and after the intervention by a HCPC registered Health 
Psychologist at the NIHR Clinical Research Facility, Royal Victoria Infirmary, Newcastle 
upon Tyne.   
Phase 2 – A single arm, feasibility and pilot study design will be used to assess the effect of 
a home-based physical activity intervention in older people with chronic heart failure due to 
systolic dysfunction. Participants will be recruited through the Royal Victoria Infirmary and 
Freeman Hospitals in Newcastle and will be screened prior to commencement of the study 
to assess eligibility. Eligible participants will then be given clinical and physiological baseline 
assessments. Following baseline assessments, participants will undergo a 12-week 
personalised home-based physical activity intervention. The goal is that each study 
participant increases activity levels (e.g. daily number of steps) from the baseline. The target 
is that participants reach the activity level that is at least 2000 steps per day more from 
baseline, as this increment is associated with a significant 10% reduction in cardiovascular 
events in individuals at high cardiovascular risk [21].  A commercial physical activity 
monitoring device (pedometer i.e. step counter; Omron, USA) will be provided for use 
throughout the study to allow participants to self-monitor activity levels to enhance motivation.  

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Sample size 
A total of 40 participants with heart failure due to left ventricular dysfunction will be recruited 
from Newcastle Royal Victoria Infirmary and Freeman Hospital.  
 
Eligibility criteria 
Inclusion criteria: 
1. Older adults (>60 years of age) with chronic heart failure due to left ventricular 
systolic dysfunction 
2. Clinically stable for at least 6 weeks prior to screening   
3. Receipt of optimal medical treatment  
4. Able to walk and perform activities of daily living independently  
5. New York Heart Association functional class II-IV  
6. Left ventricular ejection fraction <40%  
7. Willingness to undertake a physical activity intervention 
8. Willingness to visit the clinical research facility on 2 separate occasions.  
9. Ability to read, write and converse in English without the support of an interpreter.  
Exclusion criteria: 
1. Severe aortic stenosis 
2. Severe cardiac arrhythmias  
3. Myocardial infarction, percutaneous coronary intervention and/or bypass graft 
surgery over the past 3 months   
4. Clinically unstable with recent changes in medication  
5. Severely obese i.e. body mass index >35 
6. Implanted with left ventricular assist device  
7. Current participation in cardiac rehabilitation programme or in the past 3 months 
8. Inability to provide informed consent. 
 
Recruitment procedures 
Patients will be recruited from Heart Failure Clinics of Newcastle Royal Victoria Infirmary and 
Feeman Hospital run by Drs Skinner, Bailey, and MacGowan. Eligible patients will be 
contacted by the member of the study team. An information sheet will be mailed out upon 
request, and should individuals wish to take part in the study, a screening visit will be 
arranged where informed consent will be obtained. Consent forms will be signed by the 
participant and countersigned by a member of the study team.  
 

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Research Visits – In addition to attending the focus group, eligible participants will attend 
the Clinical Research Facility of the Royal Victoria Infirmary for two separate visits i.e. before 
and after the 12-week intervention. Participants will be contacted via email, telephone or 
spoken to in person to discuss the project and will be taken through the information sheet to 
ensure they understand the nature of the study. Each visit will last 3.5-4 hours and includes 
one hour break for breakfast. The following clinical investigations will be performed during 
the visits 1 and 2: 
 
i) Consent and Screening Questionnaires (30 minutes). 
- Patients will be provided with the opportunity to ask further questions and requested to 
provide written informed consent. They will then be asked to complete Physical 
Activity and Quality of Life measures i.e. Minnesota Living with Heart Failure 
Questionnaires.    
 
ii) Blood Sample(15 min). 
- After an overnight fast, the blood sample will be taken from the antecubital vein. The blood 
sample will be assessed for brain natriuretic peptides (NTproBNP), lipid profile (total 
cholesterol, HDL-cholesterol, LDL-cholesterol), triglycerides, glucose, HbA1c, 
markers of renal function (urea, creatinine, eGFR), markers of inflammation (TNFα, 
CRP), endothelial progenitor cells, and circulating endothelial cells.    
 
iii) Body composition using non-invasive air displacement plethysmography (15 min). 
- The amount of fat and muscle in the body will be assessed using air displacement 
plethesmography(BodPod). The participant will sit quietly in the bodpod wearing swimwear 
for 2 minutes. 
 
iv) Breakfast (60 min) 
- As participants are coming following an overnight fast, they will be provided with a light 
breakfast consisting of a toast and orange juice.     
 
v) Electrocardiography (ECG)(10 min). 
- The ECG will be performed using a standard 12-lead electrocardiogram in supine position.  
 
vi) Echocardiography for assessment of cardiac structure and function using non-invasive 
Doppler ultrasound (30 min). 
- An echocardiogram is an ultrasound scan of the heart. Participant will be undressed to the 
waist and asked to lie on the couch. A probe (e.g. thick blunt pen) is placed on the 

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chest. Lubricating jelly is put on the chest to form good contact between the probe 
and skin. The probe is connected by a wire to the ultrasound machine and monitor. 
Pulses of ultrasound are sent from the probe through the skin towards the heart. The 
ultrasound waves then echo ('bounce back') from the heart and various structures in 
the heart.  
 
vii) Arterial stiffness using non-invasive pulse wave analysis methods (10 min). 
- Arterial stiffness, as a measure of arterial function, will be assessed using the SphygmoCor 
device which allows for both pulse wave analysis and pulse wave velocity to be 
performed non-invasively using the gold standard techniques. The measurement is 
simple and painless, taking only a few minutes to perform. While the participant is in 
a comfortable supine position, the researcher will place a tonometer (pencil-like 
sensor) gently against the wrist and will record blood pressure signal from the pulse.  
 
viii) Cardiac autonomic function (10 min). 
- Cardiac autonomic function i.e. heart rate and blood pressure variability will be assessed 
using non-invasive methods integrated into the TaskForce device. Using 
electrocardiogram and continuous blood pressure monitoring with a finger cuff under 
resting supine condition computer will assess heart rate variability and blood 
pressure variability. 
 
ix) Progressive cardiopulmonary exercise test (30 min). 
- A progressive exercise test will be undertaken to assess non-invasively oxygen extraction 
efficiency, peak oxygen uptake, and ventilatory threshold. Patients will be asked to 
wear facemask to collect and analyse expired gasses. An ECG, blood pressure, and 
cardiac output (using non-invasive bioreactance method that utilise 4 dual electrodes 
placed on the back side of the thorax) will also be performed (resting and during the 
exercise). In brief, using a cycle ergometer the progressive exercise test involves 
maintaining a pedal frequency of 60-70 revolutions per minutes with work increasing 
at 1 minute intervals. The test will be terminated when the patient is unable to 
maintain pedal frequency above 60 rpm or the patient voluntary terminates the test. 
Exercise testing will be performed by DH and DGJ.     
DH and DGJ have experience in conducting exercise tests in patients with various clinical 
conditions including those with heart failure. DH and DGJ are first aid, CPR and 
defibrillator trained. DH or DGJ will be accompanied by one other first aid trained 
supervisor for all testing sessions. 
 

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x) Physical activity monitoring. 
- At the end of all investigations the patient will be provided with the small, unobtrusive 
accelerometery monitor (i.e. wrist-watch or arm-band like device and pedometer for 
counting daily number of steps) to assess physical activity level over a 7-day period. 
The monitor will be returned to the research team through the post in provided pre-
paid envelope. 
Intervention 
The aim of the intervention is that study participants increase their overall daily physical 
activity level by at least 2000 steps from baseline (e.g. walking at low intensity for 
approximately 30 minutes). This can be divided into several bouts of shorter duration 
throughout the day e.g. 3 x 10 min or similar with overall aim that at the end of the each day 
pedometer indicates at least 2000 steps more from the average daily number of steps 
obtained at baseline. 
Patients will be asked to complete a daily exercise diary which will be analysed and 
discussed on a weekly basis (as appropriate) with the member of the research team. Each 
exercise session will include a warm-up period, the main part of the training and a cool-down 
period that will be explained during the visit 1. To control for exercise intensity patients will 
be instructed to use standardised Borg Scale (0-20) to rate perceived exertion aiming for 
achieving the levels between 11 – 13 (easy-light-to somewhat hard). The exercise 
prescription will be progressed individually as conditioning took place, with the emphasis 
placed on volume of activity i.e. duration before intensity. 
 
End of the Study 
At the end of the study all participants will be provided with information about any changes 
observed in their cardiovascular and physiological function. This will be communicated by 
letter mailed to the participants home address and will also include an invitation to attend a 
volunteer feedback evening at the Clinical Research Facility where the overall results of the 
study will be presented. The study will be completed when study participants have 
completed the study and have attended the final visit at week 12. 
 
Statistical Analysis  
Data from this pilot study will be analysed and used to inform sample size requirements of a 
larger scale study. The sample size of 40 will provide high power to the study (β=0.82) to 
detect significant change (α=0.05) in a clinical hallmark of HF i.e. exercise intolerance (peak 
O2 consumption of 3 ml/min/kg) following the intervention. Prior to statistical analysis, data 
will be checked for univariate and mulitivariate outliers using Z-distribution cut-offs and 

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Mahanolobis distance test. Normality of distribution will be assessed using a Kolmogorov-
Smirnov test. T-tests for paired samples will be used to assess the effect of intervention on 
outcomes measures. The relationship between physical activity, clinical and physiological 
variables will be assessed using Pearson’s product moment coefficient of correlation or 
Spearman's rank correlation coefficient, as appropriate. Statistical significance was indicated 
if P<0.05. 
 
References 
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