We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Activity Monitor Use in COPD Patients Undergoing Rehabilitation

This study is currently recruiting participants.
Verified September 2016 by Glenn Cardwell, Salford Royal NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT02895152
First Posted: September 9, 2016
Last Update Posted: September 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Glenn Cardwell, Salford Royal NHS Foundation Trust
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic Bronchitis Behavioral: Feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Role of Activity Monitors in Improving Physical Activity in COPD Patients Participating in Pulmonary Rehabilitation

Resource links provided by NLM:


Further study details as provided by Glenn Cardwell, Salford Royal NHS Foundation Trust:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2016
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Feedback
Those randomised to the feedback arm will receive weekly feedback on their activity levels and tailored advice on how to improve activity levels.
Behavioral: Feedback
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
No Intervention: Control
Control arm will wear the activity monitor as specified in the protocol but will not receive feedback on activity levels

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02895152


Contacts
Contact: Patricia Kelly patricia.kelly@srft.nhs.uk
Contact: Glenn Cardwell, MBChB, MRCP glen.cardwell@srft.nhs.uk

Locations
United Kingdom
Salford Royal NHS Foundation Trust Recruiting
Salford, Greater Manchester, United Kingdom, M6 8HD
Contact: Natalie Garratt       Natalie.Garratt@manchester.ac.uk   
Principal Investigator: Nawar D Bakerly, MD, FRCP         
Sub-Investigator: Glenn Cardwell, MBChB, MRCP         
Sponsors and Collaborators
Salford Royal NHS Foundation Trust
Investigators
Principal Investigator: Nawar D Bakerly, MD, FRCP Salford Royal NHS Foundation Trust
  More Information

Responsible Party: Glenn Cardwell, Clinical Research Physcian, Salford Royal NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02895152     History of Changes
Other Study ID Numbers: 197737
First Submitted: August 30, 2016
First Posted: September 9, 2016
Last Update Posted: September 9, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Glenn Cardwell, Salford Royal NHS Foundation Trust:
COPD
Chronic Obstructive Pulmonary Disease
Pulmonary Rehabilitation
Activity Monitors
Fitbit
Fitness Tracker

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections