Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD (TROOPeR)
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|ClinicalTrials.gov Identifier: NCT02706613|
Recruitment Status : Completed
First Posted : March 11, 2016
Last Update Posted : September 14, 2016
Over time, patients with COPD (Chronic Obstructive Pulmonary Disease) develop progressive symptoms of breathlessness, which can limit day-to-day activities and tolerance to exercise. Pulmonary Rehabilitation (PR) is an established intervention in the management of COPD and is a structured programme of exercise training and education. Pulmonary Rehabilitation encourages and enables patients to improve their exercise capacity incrementally over the course of a six-week programme. An established evidence base has placed PR at the centre of interventions for COPD and its provision is mandated by NICE as a key pillar of integrated care.
Currently, the provision of PR in the NHS is limited to group sessions run over an established protocol of 6 weeks. Whilst this has been demonstrated to improve exercise capacity, access to PR classes can be problematic for some patients. Also, staff and facility resources limit delivering the programme at scale. An online PR programme developed by my mhealth known as 'myPR', in consultation with patients and physiotherapy experts, offers an alternative provision of this important intervention.
The study aims to compare this online PR programme to conventional face-to-face PR as currently delivered by the NHS. The study aims to recruit 106 patients referred for PR from Portsmouth Hospital and local Participant Identification Centres.They will then be assessed for suitability onto PR, consented and randomised onto an arm of the study. 36 will undertake a conventional PR programme as reflected in the NHS, and 70 the online PR programme known as 'myPR'. Pre and post programme measurements including walking distance and quality of life questionnaires will then be compared between each arm of the trial, to ensure that the online PR is not inferior to the conventional face-to-face PR.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Diseases||Behavioral: Face to Face Pulmonary Rehabilitaton Behavioral: Online Pulmonary Rehab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomised Controlled Research Study Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
Face to Face Pulmonary Rehabilitaton
6 week incremental pulmonary rehabilitation (PR) programme. Participants will attend 12 sessions over the 6 week period. The components of the PR programme will include an exercise programme. Education sessions will also be provided and include anatomy of the lungs and what is COPD, anxiety and depression, self management, managing breathlessness, medications and treatments, managing exacerbations of COPD and chest infections, clearing sputum and the Active Cycle of Breathing Technique, nutrition, pacing, smoking cessation. Participants on the face to face arm will also be instructed to carry out the pulmonary rehabilitation exercises an additional three times a week at home.
Behavioral: Face to Face Pulmonary Rehabilitaton
6 week face to face, incremental exercise and education programme for people with COPD
Active Comparator: Online Pulmonary Rehabilitation
Those randomised to receive the online programme will be given log-in details and a password, and instructions to begin the 6 week programme at home. The online programme mirrors the conventional face-to-face PR programme and the exercise and educational components are given by means of instructional videos. Participants will be instructed to exercise five times a week. Participants in the online arm will receive during the PR course telephone contact to record any adverse or serious adverse events.
Behavioral: Online Pulmonary Rehab
6 week online, incremental exercise and education programme for people with COPD
- Six Minute Walk Distance [ Time Frame: 6 weeks ]The 6- minute walking distance (6MWD) is assessed by carrying out the 6 Minute Walk Test (6MWT).The aim of the 6MWT is to measure walking endurance and distance over a 30m course. The patient is asked to walk as far as possible along a designated course, at a self-regulated rate for 6 minutes. Within this time they can stop and rest as needed. The patient's final walking distance is recorded (6MWD).
- COPD Assesment Tool (CAT) [ Time Frame: 6 weeks ]This is a validated symptom-scoring questionnaire used in COPD studies. The CAT questionnaire contains 8 questions and provides a reliable measure of the impact of COPD on health status. The higher the CAT score the greater the impact on health staus.
- St Georges Respiratory Questionnaire [ Time Frame: 6 weeks ]This is a validated symptom-scoring questionnaire used in COPD studies. The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. Scores are calculated for three domains Symptoms, Activity and Impacts (Psycho-social).
- Hospital Anxiety and Depression scale [ Time Frame: 6 weeks ]This was developed to determine the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen-item scale. Seven of the items relate to anxiety and seven relate to depression.11 If a participant scores higher than 8/21 on either the anxiety or depression scale, a letter will be sent to their GP informing them of their patients abnormal score so that a consultation can be arranged and treatment be provided as required.
- Modified Medical Research Council Dyspnoea scale [ Time Frame: 6 weeks ]The MRC breathlessness scale comprises five statements that describe almost the entire range of respiratory disability from none (Grade 1) to almost complete incapacity (Grade 5). It is self-administered by asking subjects to choose a phrase that best describes their condition, e.g. 'I only get breathless with strenuous exertion' (Grade 1) or 'I am too breathless to leave the house' (Grade 5). The score is the number that best fits the patient's level of activity. All the questions relate to everyday activities and are easily understood by patients
- Safety [ Time Frame: 6 weeks ]Safety will be evaluated from reported adverse and serious adverse evenets reported by the patients during the 6 week intervention
- Adherence [ Time Frame: 6 week ]A register of attendance will be maintained in the face to face arm. In the online arm the number of days accessing the online programme will be recorded
- Usability of online platform [ Time Frame: 6 weeks ]This qualitative information will be obtained by using a feedback form
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): NCT02706613
|Portsmouth Hospital NHS Trust|
|Portsmouth, Hampshire, United Kingdom, PO6 3LY|
|Principal Investigator:||Ben Green, Dr||Portsmouth Hospitals NHS Trust|