Condition category
Respiratory
Date applied
14/08/2014
Date assigned
23/09/2014
Last edited
23/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a severe lung condition that affects a person's ability to exercise and perform normal physical functions due to a combination of breathlessness, poor physical fitness and loss of muscle strength. Patients with COPD often experience flare ups known as exacerbations due to chest infections, which result in their symptoms getting worse, more loss of function, and may require hospital treatment. Recovery from such exacerbations is often slow, and some patients never fully return to their previous level of activity. This can lead to permanent disability and premature death. The purpose of this study is to find out whether it is possible to undertake a larger study of exercise training in patients who have been admitted to hospital with a flare up of their COPD. We aim to find out whether patients will be willing to participate and perform exercise both during their time in hospital and then immediately after they get home, to see if this will allow patients to recover more quickly and get back to their previous level of activity without needing to stay in hospital for a prolonged period. Both of these periods of exercise will be started much earlier than the rehabilitation classes that are currently widely available to COPD patients after they have been in hospital. This study will help us to understand if exercising earlier after hospital admission has any benefits over exercising later and will help us to decide if a large study looking more closely at this is required.

Who can participate?
Patients who have been admitted to hospital with a flare up of their COPD.

What does the study involve?
The study will look at two different sorts of exercise: a bedside bicycle-based activity that can be undertaken whilst the patient is sat at the edge of their bed in hospital, and a supervised exercise program to be undertaken during the first two weeks after they have been discharged. Both forms of exercise will be supervised by a physiotherapist. The study will look at whether participants will be prepared to take a walking test and a special movement watch that patients will wear at home. They will also be asked to complete several questionnaires that ask about their activities at home and how their breathing problems are affecting their quality of life. Whilst they are in hospital a measurement of their muscle size will be done to see whether the exercise helps stops the muscles from wasting away when they are unwell. We will assess whether or not exercising participants early after a hospital admission has any affect in preventing further chest infections or flare ups of COPD, or reduces the number of re-admissions to hospital occurring within 3 months of discharge.


What are the possible benefits and risks of participating?
Participants may benefit from being in the study as exercise has been shown to help with recovery following COPD flare ups, and it is recommended that this activity starts within a month of being in hospital. However, in this study the exercise will happen in hospital and straight after discharge, which is earlier than what currently happens. There is the possibility that doing the exercise earlier may not be beneficial, and could cause some problems such as more difficulty breathing and muscle tiredness, but the activity will be carried out with a trained physiotherapist who is aware of these risks and will be looking out for them.

Where is the study run from?
The study will be run in Sheffield Teaching Hospitals NHS Foundation Trust and Aintree University Hospital NHS Foundation Trust (in Liverpool), with patients recruited from the Northern General Hospital and from Aintree University Hospital (UK).

When is the study starting and how long is it expected to run for?
The study will run from January 2015 to December 2016.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Dr Rodney Hughes
rodney.hughes@sth.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rodney Hughes

ORCID ID

Contact details

Respiratory Medicine
Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hallamshire Hospital
Glossop Road
Sheffield
S10 2JF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 13/24/03

Study information

Scientific title

Pulmonary Rehabilitation and ACTIvity after COPD Exacerbations: the PRACTICE trial: a randomised trial

Acronym

PRACTICE

Study hypothesis

This is a feasibility and pilot study.
Feasibility outcomes:
1. Feasibility of recruitment to main trial (recruitment of 76 participants in 7m from two centres (primary outcome)
2. Recruitment and attrition rates (CONSORT data)
3. Number of missing values/incomplete cases
4. Intervention adherence
5. Intervention fidelity
6. Participant views on acceptability of research procedures and intervention
7. Therapist views on intervention/research protocol acceptability
8. Feasibility of recruiting participating centres
9. Decision on primary endpoint for main trial

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/132403

Ethics approval

Health Research Authority

Study design

Parallel-group randomised pilot trial with nested qualitative research

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Patients are randomised to:
1. In-hospital exercise training with or without in-home post-discharge early rehabilitation (n=38)
2. Standard in-hospital care with or without in-home post-discharge early rehabilitation (n=38)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Feasibility of recruitment to main trial (recruitment of 76 participants in 7m from two centres [primary outcome])
2. Six-minute walk distance at three months (clinical primary outcome)

Secondary outcome measures

Feasibility outcomes:
1. Recruitment and attrition rates (CONSORT data)
2. Number of missing values/incomplete cases
3. Intervention adherence
4. Intervention fidelity
5. Participant views on acceptability of research procedures and intervention
6. Therapist views on intervention/research protocol acceptability
7. Feasibility of recruiting participating centres
8. Decision on primary endpoint for main trial

Clinical outcomes:
1. London Chest Activity of Daily Living scale
2. EQ-5D-5L
3. COPD Assessment Test
4. Rectus femoris muscle cross-sectional area
5. MRC Breathlessness Score
6. SenseWear Armband and electronic diary
7. Serious adverse events
8. Health and social care resource use
9. Perceived necessity and concerns
10. Exacerbations
11. Readmission

Overall trial start date

01/01/2015

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinically identified exacerbation of diagnosed COPD
2. pH above 7.35
3. Maintaining oxygen saturation (SpO2) within prescribed target range with or without controlled oxygen at rest
4. Glasgow Coma Scale (GCS) 15 and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

76

Participant exclusion criteria

1. Predicted length of hospital stay <5 days
2. Acute MI/heart failure within last 6 weeks
3. Suspected/confirmed PE within last 6 weeks
4. Cardiovascular instability
5. Pulmonary fibrosis
6. Musculoskeletal conditions limiting exercise capacity

Recruitment start date

01/01/2015

Recruitment end date

31/12/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Respiratory Medicine
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust (UK)

Sponsor details

c/o Jim Lithgow
Clinical Research Office
11 Broomfield Rd
Sheffield
S10 2SE
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK); Ref.: 13/24/03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes