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Activity Monitor Use in COPD Patients Undergoing Rehabilitation

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD, Emphysema

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Feedback
Sponsored by
Northern Care Alliance NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Activity Monitors, Fitbit, Fitness Tracker

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Salford Royal NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Feedback

Control

Arm Description

Those randomised to the feedback arm will receive weekly feedback on their activity levels and tailored advice on how to improve activity levels.

Control arm will wear the activity monitor as specified in the protocol but will not receive feedback on activity levels

Outcomes

Primary Outcome Measures

Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
from the data recorded on the device

Secondary Outcome Measures

Assessment of exercise capacity: 6 minute walk test (comparing the 2 groups and in comparison to baseline)
Self reported exercise diary - duration of exercise
Self reported exercise diary - BORG (perceived activity levels and effort scale)
Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)
Assessment of symptom severity using Hospital Anxiety and Depression Scale (comparing the 2 groups and in comparison to baseline)
Assessment of symptom severity using the Patient Activation Measure Score (comparing the 2 groups and in comparison to baseline)
Assessment of symptom severity using the Chronic Respiratory Disease Questionaire Score (comparing the 2 groups and in comparison to baseline)

Full Information

First Posted
August 30, 2016
Last Updated
April 7, 2022
Sponsor
Northern Care Alliance NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02895152
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northern Care Alliance NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD, Emphysema, Chronic Bronchitis
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Activity Monitors, Fitbit, Fitness Tracker

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback
Arm Type
Experimental
Arm Description
Those randomised to the feedback arm will receive weekly feedback on their activity levels and tailored advice on how to improve activity levels.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control arm will wear the activity monitor as specified in the protocol but will not receive feedback on activity levels
Intervention Type
Behavioral
Intervention Name(s)
Feedback
Intervention Description
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
Primary Outcome Measure Information:
Title
Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*
Description
from the data recorded on the device
Time Frame
Through Study completion, upto 7 weeks total
Secondary Outcome Measure Information:
Title
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
Title
Self reported exercise diary - duration of exercise
Time Frame
Through Study completion, upto 7 weeks total
Title
Self reported exercise diary - BORG (perceived activity levels and effort scale)
Time Frame
Through Study completion, upto 7 weeks total
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nawar D Bakerly, MD, FRCP
Organizational Affiliation
Northern Care Alliance NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
State/Province
Greater Manchester
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Activity Monitor Use in COPD Patients Undergoing Rehabilitation

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