Efficacy of Physical Activity Tele-coaching to Optimise Daily Physical Activity Levels in Lung Transplant Recipients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Northumbria University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in daily physical activity
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients referred for single or double lung transplant with a primary diagnosis of Interstitial Lung Disease, Chronic Obstructive Pulmonary Disease, Cystic Fibrosis, Bronchiectasis or Pulmonary Vascular Disease.
- •Males and females aged 18-70 years.
- •Able to provide informed consent
- •Able to speak and read English.
Exclusion Criteria
- •Severe post-transplant critical illness neuromyopathy
- •Bilateral diaphragmatic weakness
- •Presence of any other significant disease or disorder which, in the opinion of the investigators, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Arms & Interventions
Tele-coaching + Usual Care
This group will undergo a 12 week physical activity tele-coaching intervention consisting of a step-counter and smartphone application, in addition to usual care. Usual care will also include sessions where behavioural strategies will be implemented to promote a physically active lifestyle.
Intervention: Tele-coaching + Usual Care (Behavioral)
Usual Care
This group will receive sessions where behavioural strategies will be implemented to promote a physically active lifestyle.
Outcomes
Primary Outcomes
Change in daily physical activity
Time Frame: Measured for 1 week pre-transplant, measured for 1 week at randomisation (1-2 months post-transplant), 1 week following the 3 month intervention, 1 week at 6 months post randomisation and 1 week at 12 months post-randomisation.
The daily number of steps will be measured using a triaxial accelerometer.
Secondary Outcomes
- Survival(12 months)
- Change in hospital anxiety and depression score(Measured pre-transplant, at randomisation (1-2 months post-transplant), post intervention, 6 months and 12 months post randomisation.)
- Change in health-related quality of life(Measured pre-transplant, at randomisation (1-2 months post-transplant), post intervention, 6 months and 12 months post randomisation.)
- Time to first hospitalisation and emergency department visit(12 months)
- Adherence to tele-coaching intervention(Information gathered after the 3 month intervention)
- Change in functional capacity(Measured pre-transplant and at randomisation (1-2 months post-transplant).)
- Patient acceptability(Assessed after the 3 month intervention.)