Lung Transplant Recipients Clinical Trial
Official title:
Efficacy of Physical Activity Tele-coaching to Optimise Daily Physical Activity Levels in Lung Transplant Recipients
Lung transplantation is an established treatment for patients with end-stage lung disease.
Despite the overall success of the treatment to prolong survival and restore lung function,
limitations in exercise capacity in the range of 40-60% of predicted normal values are
commonly observed, even up to 1 year following the transplant. These persisting limitations
are predominantly owed to skeletal muscle abnormalities including muscle atrophy, weakness
and increased fatigability, secondary to prolonged deconditioning
Based on objective accelerometry measurements, lung transplant recipients are markedly
inactive in daily life compared to their healthy age-matched counterparts. Locomotor muscle
weakness following extended hospital and intensive care unit stay, immunosuppressant
medications, and the psychological effects of transplantation contribute to persisting
physical inactivity and impaired exercise capacity.
Physical activity is a complex health behaviour that is modified by behavioural change
interventions. Such interventions may combine the use of wearable monitors (i.e. step
counters) with goal setting to increase daily physical activity. In patients with chronic
obstructive pulmonary disease (COPD), use of a semi-automated tele-coaching intervention
consisting of a step-counter and smartphone application, in combination with behavioural
strategies (identification of barriers, goal setting, self-efficacy, motivation,
self-monitoring and feedback) increases both daily physical activity levels and quality of
life. However, the effectiveness of tele-coaching to induce meaningful improvements in daily
steps to transpire into enhanced post-surgery outcomes and improve recovery is yet to be
investigated in lung transplant recipients.
Alongside physical activity promotion, incorporation of behavioural strategies are also
important in terms of reversing physical inactivity in patients with chronic lung diseases.
These strategies address barriers to physical activity including low self-motivation and
self-efficacy, and constitute an important component in the management of chronic diseases to
improve long term engagement in activities of daily living.
Accordingly, this study will assess the feasibility and clinical efficacy of physical
activity tele-coaching to enhance daily physical activity levels within a population at high
risk for post-surgical complications. The intervention combines usual care with
tele-coaching, which is designed to embed behavioural change and remote coaching to adhere to
simple daily physical activity tasks. Behavioural strategies targeted at improving physical
activity levels will be applied to all patients prior to hospital discharge, to promote more
active lifestyle choices.
Project Plan
This is a single centre, feasibility, parallel two group, randomised controlled trial. We
will investigate the effect of adding 3-months of tele-coaching to usual care (UC) versus UC
on daily physical activity levels following lung transplantation.
Planned interventions
Following lung transplantation patients will be randomised to: 1) 3 months of tele-coaching
in addition to usual care or 2) usual care. Randomisation will be performed independently,
with 1:1 allocation and stratified by functional capacity assessed by the 6-min walk distance
immediately prior to hospital discharge. Stratification will ensure that patients in the two
groups are matched in terms of post-surgery functional capacity. Additionally, whilst in
hospital all patients will receive sessions (1-3) where behavioural strategies will be
implemented to promote physical activity.
Semi-automated Tele-coaching
The tele-coaching intervention will last for 3 months and will consist of 1) a one-to-one
interview exploring motivational factors, potential physical barriers, preferred and
non-preferred activities and strategies to become more active. Patients develop a plan to
increase physical activity with the interviewer, based on preferred and achievable
activities; 2) a step counter providing direct feedback to the patient; 3) smartphone with
tele-coaching application providing an activity goal (daily steps) and feedback on a daily
basis. Patients' targets are automatically revised every 7 days based on performance in the
preceding week; 4) Booklet containing home exercises, which are available in 3 levels of
difficulty and consist of general strengthening and stretching exercises; 5) weekly activity
proposals; 6) telephone contacts triggered in the case of failure to transmit data or
progress. Patients will be asked to wear the step counter during waking hours and interact
with the application on a daily basis.
Whilst on the waiting list and during hospital stay post-surgery patients will be
familiarised with the operation of the step counter and will be taught how to monitor their
daily activity levels (daily/steps), how to transfer data from the step counter to the smart
phone and to the platform and how to follow ques to adjust their daily step goals.
Behavioural strategy sessions
Sessions implementing behavioural strategies to promote physical activity will be
administered to all patients. Strategies that will be used include; education on the benefits
of physical activity, creating a "pros and cons" list, goal setting, self monitoring and
rating achievement/pleasure of physical activities.
Assessments
Whilst on the waiting list patients will be screened for any contraindications and will
undertake a 6-minute walk test (6MWT) to assess functional capacity and questionnaires to
assess anxiety, depression and health related quality of life (HADS and SF-36). Additionally,
patients will be given an accelerometer for 7 days to record daily physical activity levels.
Prior to hospital discharge or soon afterwards, the following assessment measures will be
undertaken; 6MWT, HADS, SF-36 and daily physical activity levels using an accelerometer. All
measures will then be repeated after 3, 6 and 12 months. In addition, a record of hospital
admissions and emergency department visits will be taken.
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