Your browser doesn't support javascript.
loading
Minimal versus specialist equipment in the delivery of pulmonary rehabilitation: protocol for a non-inferiority randomised controlled trial.
Nolan, Claire M; Walsh, Jessica A; Patel, Suhani; Barker, Ruth E; Polgar, Oliver; Maddocks, Matthew; Gao, Wei; Wilson, Rebecca; Fiorentino, Francesca; Man, William.
Afiliación
  • Nolan CM; Harefield Respiratory Research Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK c.nolan@rbht.nhs.uk.
  • Walsh JA; National Heart and Lung Institute, Imperial College London, London, UK.
  • Patel S; Harefield Respiratory Research Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
  • Barker RE; Harefield Respiratory Research Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
  • Polgar O; National Heart and Lung Institute, Imperial College London, London, UK.
  • Maddocks M; Harefield Respiratory Research Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
  • Gao W; National Heart and Lung Institute, Imperial College London, London, UK.
  • Wilson R; Harefield Respiratory Research Group, Guy's and St Thomas' Hospitals NHS Trust, London, UK.
  • Fiorentino F; Cicely Saunders Institute, Division of Palliative Care, Policy & Rehabilitation, King's College London, London, UK.
  • Man W; Cicely Saunders Institute, Division of Palliative Care, Policy & Rehabilitation, King's College London, London, UK.
BMJ Open ; 11(10): e047524, 2021 10 18.
Article en En | MEDLINE | ID: mdl-34663653
INTRODUCTION: Pulmonary rehabilitation (PR), an exercise and education programme for people with chronic lung disease, aims to improve exercise capacity, breathlessness and quality of life. Most evidence to support PR is from trials that use specialist exercise equipment, for example, treadmills (PR-gym). However, a significant proportion of programmes do not have access to specialist equipment with training completed with minimal exercise equipment (PR-min). There is a paucity of robust literature examining the efficacy of supervised, centre-based PR-min. We aim to determine whether an 8-week supervised, centre-based PR-min programme is non-inferior to a standard 8-week supervised, centre-based PR-gym programme in terms of exercise capacity and health outcomes for patients with chronic lung disease. METHODS AND ANALYSIS: Parallel, two-group, assessor-blinded and statistician-blinded, non-inferiority randomised trial. 436 participants will be randomised using minimisation at the individual level with a 1:1 allocation to PR-min (intervention) or PR-gym (control). Assessment will take place pre-PR (visit 1), post-PR (visit 2) and 12 months following visit 1 (visit 3). Exercise capacity (incremental shuttle walk test), dyspnoea (Chronic Respiratory Questionnaire (CRQ)-Dyspnoea), health-related quality of life (CRQ), frailty (Short Physical Performance Battery), muscle strength (isometric quadriceps maximum voluntary contraction), patient satisfaction (Global Rating of Change Questionnaire), health economic as well as safety and trial process data will be measured. The primary outcome is change in exercise capacity between visit 1 and visit 2. Two sample t-tests on an intention to treat basis will be used to estimate the difference in mean primary and secondary outcomes between patients randomised to PR-gym and PR-min. ETHICS AND DISSEMINATION: London-Camden and Kings Cross Research Ethics Committee and Health Research Authority have approved the study (18/LO/0315). Results will be submitted for publication in peer-reviewed journals, presented at international conferences, disseminated through social media, patient and public routes and directly shared with stakeholders. TRIAL REGISTRATION NUMBER: ISRCTN16196765.
Asunto(s)
Palabras clave

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Tolerancia al Ejercicio Tipo de estudio: Clinical_trials Aspecto: Ethics / Patient_preference Límite: Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Tolerancia al Ejercicio Tipo de estudio: Clinical_trials Aspecto: Ethics / Patient_preference Límite: Humans Idioma: En Revista: BMJ Open Año: 2021 Tipo del documento: Article Pais de publicación: Reino Unido