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Physical Activity Tele-coaching in Lung Transplant Recipients

27 aprile 2020 aggiornato da: Northumbria University

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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
      • Newcastle upon Tyne, Regno Unito, NE7 7DN
        • Reclutamento
        • Freeman Hospital
        • Contatto:
        • Contatto:
        • Sub-investigatore:
          • Arun Nair, MD FRCP Edin MPVD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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
  4. Able to speak and read English.

Exclusion Criteria:

  1. Severe post-transplant critical illness neuromyopathy
  2. Bilateral diaphragmatic weakness
  3. 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: Usual Care
This group will receive sessions where behavioural strategies will be implemented to promote a physically active lifestyle.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in daily physical activity
Lasso di tempo: 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.
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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in hospital anxiety and depression score
Lasso di tempo: Measured pre-transplant, at randomisation (1-2 months post-transplant), post intervention, 6 months and 12 months post randomisation.
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.
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
Lasso di tempo: Measured pre-transplant, at randomisation (1-2 months post-transplant), post intervention, 6 months and 12 months post randomisation.
Health-related quality of life will be assessed using The 36-item Short-Form Health Survey (SF-36).
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
Lasso di tempo: 12 months
Time to first hospitalisation and emergency department visit following discharge from lung transplantation.
12 months
Adherence to tele-coaching intervention
Lasso di tempo: Information gathered after the 3 month intervention
Adherence of wearing the step counter and performing the tasks of the smartphone interface
Information gathered after the 3 month intervention
Survival
Lasso di tempo: 12 months
Survival to 12 months post-transplant
12 months
Change in functional capacity
Lasso di tempo: Measured pre-transplant and at randomisation (1-2 months post-transplant).
Functional capacity will be assessed using the 6 minute walk test.
Measured pre-transplant and at randomisation (1-2 months post-transplant).
Patient acceptability
Lasso di tempo: Assessed after the 3 month intervention.
Patient acceptability of the tele-coaching intervention will be assessed using project tailored validated questionnaire.
Assessed after the 3 month intervention.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Northumbria University

Collaboratori

Newcastle-upon-Tyne Hospitals NHS Trust

Investigatori

  • Investigatore principale: Ioannis Vogiatzis, PhD, Northumbria University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2020

Completamento primario (Anticipato)

1 giugno 2021

Completamento dello studio (Anticipato)

1 settembre 2021

Date di iscrizione allo studio

Primo inviato

5 marzo 2019

Primo inviato che soddisfa i criteri di controllo qualità

12 marzo 2019

Primo Inserito (Effettivo)

13 marzo 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 aprile 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2020

Ultimo verificato

1 febbraio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 257479

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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