Activity Monitor Use in COPD Patients Undergoing Rehabilitation

NCT02895152 | Completed

• 1 other identifier: 197737
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD; Emphysema; Chronic Bronchitis

Keywords

COPD; Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation; Activity Monitors; Fitbit; Fitness Tracker

Outcome Measures

Primary Outcomes (1)

• Daily physical activity measured as: A: number of minutes active during the day; B: number of steps*

  from the data recorded on the device

  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)

  At beginning and at 7 weeks, with repeat at 6 months

• Self reported exercise diary - duration of exercise

  Through Study completion, upto 7 weeks total

• Self reported exercise diary - BORG (perceived activity levels and effort scale)

  Through Study completion, upto 7 weeks total

• Assessment of symptom severity using Copd Assessment Test (comparing the 2 groups and in comparison to baseline)

  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)

  Through Study completion, upto 7 weeks total

Study Arms (2)

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.

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

Interventions

Feedback BEHAVIORAL

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

Feedback

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Care Alliance NHS Foundation Trust: lead

Study Sites (1)

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema; Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Study Officials

• Nawar D Bakerly, MD, FRCP

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 9, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: June 1, 2018
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)