Physical Activity Tele-coaching in Lung Transplant Recipients

NCT03873597 | Unknown

• 1 other identifier: 257479
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant Recipients

Keywords

tele-coaching; physical activity; lung transplant

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• 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

Study Arms (2)

Tele-coaching + Usual Care

EXPERIMENTAL

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.

Behavioral: Tele-coaching + Usual Care

Usual Care

NO INTERVENTION

This group will receive sessions where behavioural strategies will be implemented to promote a physically active lifestyle.

Interventions

Tele-coaching + Usual Care BEHAVIORAL

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.

Tele-coaching + Usual Care

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria University: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator

Study Sites (1)

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 34282853 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ioannis Vogiatzis, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Hume, MSc

CONTACT

+44(0)191 243 7018; emily.c.hume@northumbria.ac.uk

Ioannis Vogiatzis, PhD

CONTACT

+44 (0)191 349 5446; ioannis.vogiatzis@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single centre feasibility, parallel, randomised controlled trial

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 13, 2019
• Study Start: February 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: April 28, 2020

Record last verified: 2020-02

Locations

GB (1)