Chronic Obstructive Pulmonary DiseaseNCT02895152
Activity Monitor Use in COPD Patients Undergoing Rehabilitation
A study testing Feedback in people with Chronic Obstructive Pulmonary Disease and COPD, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD, Emphysema
- What is being tested?
- Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed COPD diagnosis with spirometry: Forced expiratory volume at one second (FEV1)/Forced Vital Capacity (FVC) <70%
- Optimised pharmacology intervention
- Referred for Pulmonary Rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Salford Royal NHS Foundation Trust
Salford, Greater Manchester, M6 8HD
About this study
Official title: The Role of Activity Monitors in Improving Physical Activity in COPD Patients Participating in Pulmonary Rehabilitation
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.
Read the 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.
- Being tested
- Feedback
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Activity Monitors, Fitbit, Fitness Tracker
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Emphysema, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackBehavioural
Will receive feedback on the amount of activity that has been undertaken in the last week, will specialist advice on steps taken, active minutes each day, how much device has been worn and tailored advice on how to improve activity levels
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Experimental | Those randomised to the feedback arm will receive weekly feedback on their activity levels and tailored advice on how to improve activity levels. Receives: Behavioral: Feedback |
| Control | No intervention | Control arm will wear the activity monitor as specified in the protocol but will not receive feedback on activity levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
from the data recorded on the device
Measured: Through Study completion, upto 7 weeks total
Secondary outcomes (7)
Assessment of exercise capacity: 6 minute walk test (comparing the 2 groups and in comparison to baseline)
Measured: At beginning and at 7 weeks, with repeat at 6 months
Self reported exercise diary - duration of exercise
Measured: Through Study completion, upto 7 weeks total
Self reported exercise diary - BORG (perceived activity levels and effort scale)
Measured: Through Study completion, upto 7 weeks total
Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)
Measured: Through Study completion, upto 7 weeks total
Assessment of symptom severity using Hospital Anxiety and Depression Scale (comparing the 2 groups and in comparison to baseline)
Measured: Through Study completion, upto 7 weeks total
Assessment of symptom severity using the Patient Activation Measure Score (comparing the 2 groups and in comparison to baseline)
Measured: Through Study completion, upto 7 weeks total
Assessment of symptom severity using the Chronic Respiratory Disease Questionaire Score (comparing the 2 groups and in comparison to baseline)
Measured: Through Study completion, upto 7 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Care Alliance NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nawar D Bakerly, MD, FRCP, Principal investigator, Northern Care Alliance NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895152
- Sponsor's protocol ID
- 197737
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2016
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Activity Monitors in Improving Physical Activity in COPD Patients Participating in Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT02895152
- Acronym / sponsor ID
- 197737
- Keywords
- COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Activity Monitors, Fitbit, Fitness Tracker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Northern Care Alliance NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | Experimental | Behavioral: FeedbackThose randomised to the feedback arm will receive weekly feedback on their activity levels and tailored advice on how to improve activity levels. |
| Control | No intervention | –Control arm will wear the activity monitor as specified in the protocol but will not receive feedback on activity levels |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed COPD diagnosis with spirometry: Forced expiratory volume at one second (FEV1)/Forced Vital Capacity (FVC) <70%
- Optimised pharmacology intervention
- Referred for Pulmonary Rehabilitation
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeedbackWill receive feedback on the amount of activity that has been undertaken in the last week, will specialist advice on steps taken, active minutes each day, how much device has been worn and tailored advice on how to improve activity levels | Behavioural | Feedback |
Primary outcome
Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
Time frame: Through Study completion, upto 7 weeks total
from the data recorded on the device
7 secondary outcomes
Assessment of exercise capacity: 6 minute walk test (comparing the 2 groups and in comparison to baseline)
Time frame: At beginning and at 7 weeks, with repeat at 6 months
Self reported exercise diary - duration of exercise
Time frame: Through Study completion, upto 7 weeks total
Self reported exercise diary - BORG (perceived activity levels and effort scale)
Time frame: Through Study completion, upto 7 weeks total
Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)
Time frame: Through Study completion, upto 7 weeks total
Assessment of symptom severity using Hospital Anxiety and Depression Scale (comparing the 2 groups and in comparison to baseline)
Time frame: Through Study completion, upto 7 weeks total
Assessment of symptom severity using the Patient Activation Measure Score (comparing the 2 groups and in comparison to baseline)
Time frame: Through Study completion, upto 7 weeks total
Assessment of symptom severity using the Chronic Respiratory Disease Questionaire Score (comparing the 2 groups and in comparison to baseline)
Time frame: Through Study completion, upto 7 weeks total
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nawar D Bakerly, MD, FRCP principal investigator
Northern Care Alliance NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback in people with Chronic Obstructive Pulmonary Disease and COPD, run by Northern Care Alliance NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily physical activity measured as: A: number of minutes active during the day; B: number of steps* (time frame: Through Study completion, upto 7 weeks total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.