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

NCT02706613 | Completed

• 1 other identifier: PHT/2015/069
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Diseases

Outcome Measures

Primary Outcomes (2)

• Six Minute Walk Distance

  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).

  6 weeks

• COPD Assesment Tool (CAT)

  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.

  6 weeks

Secondary Outcomes (6)

• St Georges Respiratory Questionnaire

  6 weeks

• Hospital Anxiety and Depression scale

  6 weeks

• Modified Medical Research Council Dyspnoea scale

  6 weeks

• Safety

  6 weeks

• Adherence

  6 week

Study Arms (2)

Face to Face Pulmonary Rehabilitaton

OTHER

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

Online Pulmonary Rehabilitation

ACTIVE COMPARATOR

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

Interventions

Face to Face Pulmonary Rehabilitaton BEHAVIORAL

6 week face to face, incremental exercise and education programme for people with COPD

Face to Face Pulmonary Rehabilitaton

Online Pulmonary Rehab BEHAVIORAL

6 week online, incremental exercise and education programme for people with COPD

Online Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who have had an exacerbation requiring additional antibiotics and/or an additional course of steroids within 2 weeks prior to commencing the study.
• Patients who have already undertaken a pulmonary rehabilitation programme within the last 6 months
• Patients who have another respiratory disease as their main complaint, such as asthma, bronchiectasis, lung cancer, tuberculosis or any other significant respiratory disease.
• Uncontrolled hypertension
• Unstable cardiovascular disease that would make pulmonary rehabilitation exercise unsafe or prevent programme participation
• 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
• Patients who are unable to read, or use an internet enabled device or do not have access to the internet at home
• A timed 'Up and Go' test greater than 14 seconds

Sponsors & Collaborators

• my mhealth Ltd: lead
• Portsmouth Hospitals NHS Trust: collaborator

Study Sites (1)

Portsmouth Hospital NHS Trust

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (15)

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Sewell L, Singh SJ, Williams JE, Collier R, Morgan MD. [Can individualized rehabilitation improve functional independence in elderly patients with COPD?]. Rev Port Pneumol. 2005 Nov-Dec;11(6):593-6. No abstract available. Portuguese.

  PMID: 16514719 RESULT

• Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.

  PMID: 16738033 RESULT

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 RESULT

• Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

  PMID: 5523831 RESULT

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 RESULT

• Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.

  PMID: 3080166 RESULT

• Redelmeier DA, Bayoumi AM, Goldstein RS, Guyatt GH. Interpreting small differences in functional status: the Six Minute Walk test in chronic lung disease patients. Am J Respir Crit Care Med. 1997 Apr;155(4):1278-82. doi: 10.1164/ajrccm.155.4.9105067.

  PMID: 9105067 RESULT

• Troosters T, Gosselink R, Decramer M. Six minute walking distance in healthy elderly subjects. Eur Respir J. 1999 Aug;14(2):270-4. doi: 10.1034/j.1399-3003.1999.14b06.x.

  PMID: 10515400 RESULT

• Kon SS, Canavan JL, Jones SE, Nolan CM, Clark AL, Dickson MJ, Haselden BM, Polkey MI, Man WD. Minimum clinically important difference for the COPD Assessment Test: a prospective analysis. Lancet Respir Med. 2014 Mar;2(3):195-203. doi: 10.1016/S2213-2600(14)70001-3. Epub 2014 Feb 4.

  PMID: 24621681 RESULT

• Cote CG, Casanova C, Marin JM, Lopez MV, Pinto-Plata V, de Oca MM, Dordelly LJ, Nekach H, Celli BR. Validation and comparison of reference equations for the 6-min walk distance test. Eur Respir J. 2008 Mar;31(3):571-8. doi: 10.1183/09031936.00104507. Epub 2007 Nov 7.

  PMID: 17989117 RESULT

• 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.

  RESULT

• Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.

  PMID: 1759018 RESULT

• 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

  RESULT

• Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.

  PMID: 33511633 DERIVED

Related Links

• NICE COPD Guidelines

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Green, Dr

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: March 11, 2016
• Study Start: July 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)