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Efficacy of Physical Activity Tele-coaching to Optimise Daily Physical Activity Levels in Lung Transplant Recipients
Sponsor study identifier
interventional
40
1 country
1
Study Start
February 1, 2020
Actual (reported)Primary Completion
June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 5, 2019
Actual (reported)March 13, 2019
Actual (reported)February 1, 2020
Actual (reported)June 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in daily physical activity
The daily number of steps will be measured using a triaxial accelerometer.
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.
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
Survival
12 months
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.
This group will receive sessions where behavioural strategies will be implemented to promote a physically active lifestyle.
The tele-coaching intervention will be delivered for 3 months following discharge from hospital. This consists of: 1) An interview discussing motivational issues, favourite daily activities and strategies to become more physically active; 2) a step counter 3) a smart phone with tele-coaching application providing activity goals (daily steps), feedback and educational tips on a daily basis. Patients' targets will be automatically revised on a weekly basis, based on performance in the preceding week; (4) a booklet containing home exercises; (5) weekly activity proposals; (6) tele-phone contacts triggered in the case of non-compliance, failure to transmit data or difficulty to progress.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.
Ioannis Vogiatzis, PhD
Northumbria University
First Submitted
March 5, 2019
First Posted
March 13, 2019
Study Start
February 1, 2020
Actual (reported)Primary Completion
June 2021
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 28, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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