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Physical Activity Tele-coaching in Lung Transplant Recipients

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ClinicalTrials.gov Identifier: NCT03873597
Recruitment Status : Not yet recruiting
First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Newcastle-upon-Tyne Hospitals NHS Trust
Information provided by (Responsible Party):
Northumbria University

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 cognitive behavioural therapy (CBT) is also important in terms of reversing physical inactivity in patients with chronic lung diseases. CBT addresses several behavioural barriers including anxiety, depression and physical inactivity, and constitutes 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 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. Cognitive behavioural therapy will be applied to all patients prior to hospital discharge to alleviate distress, and help them develop more adaptive cognitions, behaviours and active lifestyle choices.


Condition or disease Intervention/treatment Phase
Lung Transplant Recipients Behavioral: Tele-coaching + Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single centre, parallel, randomised controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Physical Activity Tele-coaching to Optimise Daily Physical Activity Levels in Lung Transplant Recipients
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tele-coaching + Usual Care
In addition to usual care including 3-4 sessions of Cognitive Behavioural Therapy (CBT) during hospital stay post-transplant, patients will receive a 3 month tele-coaching intervention following discharge from hospital for lung transplantation.
Behavioral: Tele-coaching + Usual Care
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.

No Intervention: Usual Care
This group will receive usual care, including 3-4 sessions of Cognitive Behavioural Therapy (CBT) during hospital stay post-transplant.



Primary Outcome Measures :
  1. Change in daily physical activity [ Time Frame: Measured for 1 week at baseline, 1 week following the 3 month intervention, 1 week at 6 months and 1 week at 12 months. ]
    The daily number of steps will be measured using a triaxial accelerometer at baseline, post-intervention (3 months), 6 months and 12 months.


Secondary Outcome Measures :
  1. Change in functional capacity [ Time Frame: Measured at baseline, post intervention (3 months), 6 months and 12 months ]
    Functional capacity will be assessed using the 6 minute walk test.

  2. Change in hospital anxiety and depression score [ Time Frame: Measured at baseline, post intervention (3 months), 6 months and 12 months ]
    Anxiety and depression symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scale measures for Anxiety and Depression are both out of 21. Scoring is grouped as: Normal= 0-7, Borderline abnormal= 8-10, 11-21= Abnormal.

  3. Change in health-related quality of life [ Time Frame: Measured at baseline, post intervention (3 months), 6 months and 12 months ]
    Health-related quality of life will be assessed using The Medical Outcomes Study 36-item Short-Form Health Survey (SF-36).

  4. Change in functional lower body strength [ Time Frame: Measured at baseline, post intervention (3 months), 6 months and 12 months ]
    Functional lower body strength will be assessed using the 30 second sit-to-stand chair test.

  5. Time to first hospitalisation and emergency department visit [ Time Frame: 12 months ]
    Time to first hospitalisation and emergency department visit following discharge from lung transplantation.

  6. Adherence to tele-coaching intervention [ Time Frame: Information gathered after the 3 month intervention ]
    Adherence of wearing the step counter and performing the tasks of the smartphone interface

  7. Survival [ Time Frame: 12 months ]
    Survival to 12 months post-transplant

  8. Exercise capacity [ Time Frame: Assessed at baseline ]
    Exercise capacity will be assessed at baseline using the incremental shuttle walk test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Males and females aged 18-70 years.
  3. Able to provide informed consent

Inclusion to the lung transplant waiting list will be as described in the NHS Lung Candidate Selection Criteria Policy (POL231/3).

Exclusion Criteria:

Exclusion criteria for lung transplant will be as described in the NHS Lung Candidate Selection Criteria Policy (POL231/3).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873597


Contacts
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Contact: Emily Hume, MSc +44(0)191 243 7018 emily.c.hume@northumbria.ac.uk
Contact: Ioannis Vogiatzis, PhD +44 (0)191 349 5446 ioannis.vogiatzis@northumbria.ac.uk

Locations
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United Kingdom
Freeman Hospital Not yet recruiting
Newcastle upon Tyne, United Kingdom, NE7 7DN
Contact: Stephen Clark, BMedSci, BM, BS, DM, FFST,FRCP    0191 2137380    stephen.clark@newcastle.ac.uk   
Contact: Hazel Muse, BSc    0191 244 8377    hazel.muse@nuth.nhs.uk   
Sponsors and Collaborators
Northumbria University
Newcastle-upon-Tyne Hospitals NHS Trust
Investigators
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Principal Investigator: Ioannis Vogiatzis, PhD Northumbria University

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Responsible Party: Northumbria University
ClinicalTrials.gov Identifier: NCT03873597     History of Changes
Other Study ID Numbers: 257479
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Northumbria University:
tele-coaching
physical activity
lung transplant