Clinical trial NCT02895152: Activity Monitor Use in COPD Patients Undergoing Rehabilitation
Official title: The Role of Activity Monitors in Improving Physical Activity in COPD Patients Participating in Pulmonary Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Emphysema
Chronic Bronchitis
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Activity Monitors
Fitbit
Fitness Tracker
Lead sponsor: Northern Care Alliance NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In patients with Chronic Obstructive Pulmonary Disease (COPD) lifestyles with lower physical activity levels have been shown to increase the risk of hospital admissions and shorten survival rates. An established process in increasing activity levels is to undergo pulmonary rehabilitation classes.

The investigators wish to identify whether the use of activity monitors,which will provide feedback on activity levels, will increase the physical activity levels of patients with COPD outside of the supervised pulmonary rehabilitation sessions.

Detailed description: The research proposal has been developed in conjunction with the Respiratory Physicians and Physiotherapy team who deliver the pulmonary Rehabilitation sessions.

The investigators want to address if providing patients with monitors to record activity levels and then giving feedback on activity level data enhances the effect of the standard pulmonary rehabilitation program. The investigators want to pay particular attention to the levels of activity outside the duration of the rehabilitation classes - to see if higher levels of activity are reached.

This aims to be a feasibility study done on a small scale where issues such as compliance with wearing the device can be monitored closely. Compliance will be reviewed during a one week trial of wearing the device prior to starting the rehabilitation sessions. It will also enable study participants to get into the routine of wearing the device, charging etc.

Analysis of the data will be data collected during weekdays, choosing the 4 weekdays where there is a minimum of 8hrs of wearing time during waking hours. If the device has been worn for less than 8 hours, then days with most wear-time of the device will be selected. This method was chosen as it is a robust and statistically validated method of assessing activity levels in patients with COPD.

All study participants will be asked to wear the activity monitor to minimise any bias in the collected data. Subjects will be randomised as to whether they receive feedback or not.

The choice of activity monitor to be used was considered. Requirements are that it should be wrist-worn and the data collected by the device able to been downloaded through the associated computer software/"app". Wrist worn devices were chosen so that compliance in wearing the device would be maximized - they are worn in the same way a normal wrist watch would be.

A model from the brand "Fitbit" was selected based on this criteria. This was justified by previous studies showing Fitbit has good validity and usability in measuring energy expenditure in COPD patients.

As all participants in the study will partake in the pulmonary rehabilitation sessions there will be no deviations from standard care with this project. Analysis of activity will be downloaded, once a week, from the devices during the sessions and subjects randomised to receive feedback will have a 10 minute session dedicated to this.

There is a risk that subjects will have an exacerbation of their condition/chest infection during the period of pulmonary rehab. If a subject is too unwell to attend a rehabilitation session they will receive their feedback on their next attendance. Any subjects that are hospitalised during the study will be withdrawn.

Eligibility criteria: Inclusion Criteria:

* Confirmed COPD diagnosis with spirometry: Forced expiratory volume at one second (FEV1)/Forced Vital Capacity (FVC) \<70%
* Optimised pharmacology intervention
* Referred for Pulmonary Rehabilitation

Exclusion Criteria:

* FEV1 \<30% predicted
* Clinical instability - Exacerbation in preceding 6 weeks
* Other clinical condition that prevents mechanical exercise (and therefore participation in sessions) due to pain/discomfort (Arthritis etc.)
* None compliant with the use of the activity monitors. Compliance will be assessed during the 1 week before starting the pulmonary rehabilitation programme (at the same time of collecting baseline data on activity). Compliance will be defined as wearing the activity monitors for at least 85% of the time allowing for times to take it off for charging.
* Recurrent chest infections \>3 in the past 12 months.
* Unable to consent

Primary outcomes:
measure: Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
timeFrame: Through Study completion, upto 7 weeks total
Secondary outcomes:
measure: Assessment of exercise capacity: 6 minute walk test (comparing the 2 groups and in comparison to baseline)
timeFrame: At beginning and at 7 weeks, with repeat at 6 months
measure: Self reported exercise diary - duration of exercise
timeFrame: Through Study completion, upto 7 weeks total
measure: Self reported exercise diary - BORG (perceived activity levels and effort scale)
timeFrame: Through Study completion, upto 7 weeks total
measure: Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)
timeFrame: Through Study completion, upto 7 weeks total
measure: Assessment of symptom severity using Hospital Anxiety and Depression Scale (comparing the 2 groups and in comparison to baseline)
timeFrame: Through Study completion, upto 7 weeks total
measure: Assessment of symptom severity using the Patient Activation Measure Score (comparing the 2 groups and in comparison to baseline)
timeFrame: Through Study completion, upto 7 weeks total
measure: Assessment of symptom severity using the Chronic Respiratory Disease Questionaire Score (comparing the 2 groups and in comparison to baseline)
timeFrame: Through Study completion, upto 7 weeks total
Other outcomes:
Locations:
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: Northern Care Alliance NHS Foundation Trust
name: Nawar D Bakerly, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: