Condition category
Respiratory
Date applied
24/02/2017
Date assigned
12/05/2017
Last edited
12/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name given to a collection of diseases which affect the lungs. It is characterised by breathlessness, cough and excess mucus production and is often caused by smoking. People suffering from COPD often have lower levels of physical activity and exercise capacity than those without the condition, increasing their risk of hospitalisation or death. Pulmonary rehabilitation (PR) is a is a universally recognised program of exercise, education and support that is used in patients with COPD to help them improve their physical condition. PR is therefore recommended in national and international guidelines for the management of patients with COPD for all those experiencing physical restrictions to daily life. Activity monitors that record steps could be used to help patients monitor exercise training sessions and better understand their background physical activity levels; until now this has only been carried out using research style equipment, which gives no feedback to the patient. The aim of this study is to find out whether it is feasible to use a commercial activity monitor, which offers real time feedback to patients, to prescribe an exercise training programme (i.e. step count per minute of exercise), and whether this can be identified from the data retrieved from the device.

Who can participate?
Adult COPD patients who have been referred by their clinician for outpatient PR delivered from a hospital site.

What does the study involve?
After agreeing to take part, participants are instructed about how to wear and use the activity monitor device. They then complete a walking test usually used in the hospital’s pulmonary rehabilitation programme with the device in place. Using the information from the device, participants are told about their walking exercise intensity based on steps per minute and how to check this speed during exercise bouts using the activity monitor device. Participants then attend twelve pulmonary rehabilitation classes, usually over the course of six weeks. After the twelfth class participants attend a discharge assessment where the activity monitor will be returned to the researcher.

What are the possible benefits and risks of participating?
Participants may benefit from becoming more active. There are no notable risks involved with participating.

Where is the study run from?
Glenfield Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2016 to August 2017

Who is funding the study?
University Hospitals of Leicester NHS Trust (UK)

Who is the main contact?
Ms Sarah Ward
sarah.ward@uhl-tr.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sarah Ward

ORCID ID

Contact details

UHL NHS Trust
Glenfield Hospital
Leicester
LE3 9QP
United Kingdom
+44 116 258 3181
sarah.ward@uhl-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

71186

Study information

Scientific title

Can a commercial activity monitor be used to effectively prescribe exercise and increase physical activity levels in chronic respiratory patients undertaking outpatient pulmonary rehabilitation? - A feasibility study

Acronym

Study hypothesis

Study aims:
1. To to determine if patients undergoing pulmonary rehabilitation will wear an activity monitor daily to monitor their exercise
2. To determine whether it is possible to prescribe exercise using steps/min rather than traditional expressions of walking intensity
3. To determine if it is possible to identify these bouts of exercise from the data collected from the device

Ethics approval

NRES Committee North East - Newcastle & North Tyneside 1, 12/07/2016, ref: 16/NE/0236

Study design

Single-centre non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Other

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

Intervention

Participants will be identified from clinical service during routine assessment for pulmonary rehabilitation. If interested will be given an information sheet and an appointment for consenting made for a date coinciding with the participants first rehabilitation class.

Following consent being obtained the participant will undergo a walking test (same test carried out during routine assessment) with the device in place to gain specific exercise prescription parameters of steps per minute. Participants will then attend the routine pulmonary rehabilitation classes during which the researcher will analyse the data stored on the activity monitor device since the last session and spend a short time, during the usual session, giving feedback to the participant and setting new activity goals with them for the coming week. At the end of the pulmonary rehabilitation programme the participants will undertake a routine discharge assessment where the activity monitor will be collected. In total participants will be expected to attend one additional visit of approximately 30-45 minutes and complete one additional questionnaire at discharge, compared with routine clinical care.

The duration of the intervention will last as long as the course of pulmonary rehabilitation; approximately 8 weeks and there will be no follow up.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Agreement between participant reported exercise bouts and data uploaded from activity monitor device at each rehabilitation class visit
2. Agreement of walking intensity (steps per minute) from uploaded data identifying exercise bouts and prescribed walking intensity

Secondary outcome measures

Physical activity levels of participants across the course of pulmonary rehabilitation measured by average daily step count uploaded from the activity monitor device from week one to week six of the programme.

Overall trial start date

20/06/2016

Overall trial end date

01/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or above
2. Diagnosis of COPD (FEV1/FEV <0.7 measured by spirometry)
3. Stable condition, medically optimised and free of exacerbations for 30 days
4. Able (in the investigators opinion) and willing to comply with all study requirements; able to appropriately place the activity monitor device to their person
5. Willing and able to give informed consent
6. Willing to undergo a course of pulmonary rehabilitation at Glenfield Hospital

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Comorbidities that would limit participation in a pulmonary rehabilitation programme such as significant musculoskeletal, neurological or psychological conditions
2. Comorbidities that contraindicate field exercise tests such as severe ventricular dysfunction, severe aortic stenosis, hypertrophic obstructive cardiomyopathy, severe pulmonary hypertension, myocardial infarction within previous 6 weeks, hypertension with resting systolic pressure >210mmHg and/or diastolic pressure >110mmHg, abdominal aortic aneurysm >5.5cm in diameter
3. Unwilling to enrol onto the supervised outpatient pulmonary rehabilitation programme
4. No diagnosis of chronic obstructive pulmonary disease
5. Unable/unwilling to use activity monitor device throughout pulmonary rehabilitation
6. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study
7. Unable to understand written or spoken English

Recruitment start date

11/10/2016

Recruitment end date

01/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
UHL NHS Trust Groby Road
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust

Sponsor details

Research & Innovation Office
Leicester General Hospital
Gwendolen Road
Leicester
LE5 $PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospitals of Leicester NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing plan:
Participant level data will be held securely; hardcopy on secure cabinets and offices, electronic data password protected on NHS computer. Data will not be made available as it is a small feasibility study dataset carried out for an academic qualification. If a larger study is warranted as a result of this study’s results this may be made available.

Intention to publish date

31/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes