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Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD (TROOPeR)

This study has been completed.
Sponsor:
Collaborator:
Portsmouth Hospitals NHS Trust
Information provided by (Responsible Party):
my mhealth Ltd
ClinicalTrials.gov Identifier:
NCT02706613
First received: July 30, 2015
Last updated: September 13, 2016
Last verified: January 2016
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Diseases Behavioral: Face to Face Pulmonary Rehabilitaton Behavioral: Online Pulmonary Rehab

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Research Study Comparing Online Pulmonary Rehabilitation 'myPR' Versus Conventional Pulmonary Rehabilitation for Patients With COPD

Resource links provided by NLM:


Further study details as provided by my mhealth Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 90
Study Start Date: July 2015
Study Completion Date: June 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects able to complete all study procedures and give written informed consent.
  2. A diagnosis of COPD defined as per the NICE COPD guidelines with an MRC score of 2 or greater or appropriately symptomatic patients.
  3. Male or female volunteers aged 40+ with a diagnosis of COPD referred for pulmonary rehabilitation
  4. Access to the internet and ability to operate a web platform

Exclusion Criteria:

  1. Patients who have had an exacerbation requiring additional antibiotics and/or an additional course of steroids within 2 weeks prior to commencing the study.
  2. Patients who have already undertaken a pulmonary rehabilitation programme within the last 6 months
  3. Patients who have another respiratory disease as their main complaint, such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
  4. Uncontrolled hypertension
  5. Unstable cardiovascular disease that would make pulmonary rehabilitation exercise unsafe or prevent programme participation
  6. Patients who are unable to walk or whose ability to walk safely and independently is significantly impaired due to non-respiratory related conditions and/or cognitive impairment
  7. Patients who are unable to read, or use an internet enabled device or do not have access to the internet at home
  8. A timed 'Up and Go' test greater than 14 seconds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02706613

Locations
United Kingdom
Portsmouth Hospital NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
my mhealth Ltd
Portsmouth Hospitals NHS Trust
Investigators
Principal Investigator: Ben Green, Dr Portsmouth Hospitals NHS Trust
  More Information

Additional Information:
Publications:
Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of Chronic Bronchitis (MRC breathlessness score). BMJ 1960; 2: 1665.
Mesquita R et al. Timed Up and Go test in COPD: Changes over time, validity and responsiveness to pulmonary rehabilitation. ERJ September1, 2014 vol 44 suppl 58 P3037

Responsible Party: my mhealth Ltd
ClinicalTrials.gov Identifier: NCT02706613     History of Changes
Other Study ID Numbers: PHT/2015/069
Study First Received: July 30, 2015
Last Updated: September 13, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 27, 2017