Make Every Step Count: Personalised Music Feedback to Walking for People Living With COPD

NCT06629675 | Recruiting

• 1 other identifier: 0976
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Pulmonary Rehabilitation (PR) is an evidence-based intervention to effectively manage the physiological and psychological effects of Chronic Obstructive Pulmonary Disease (COPD). The aims of PR are to improve symptoms of COPD, increase exercise capacity, increase independency, improve overall behaviour related to health (like exercising more), and enhance quality of life. The cornerstone of PR programmes is aerobic exercise prescription. Typically, walking exercise is used, and the prescription is individualised for each patient based on their maximal walking exercise capacity. However, adherence to walking exercise is challenging for service users, particularly when unsupervised at home. The use of music during exercise shows promise as a tool to decrease the perception of fatigue and increase motivation, but the integration of music via smartphone applications to support walking exercise adherence during PR has not been explored. This project aims to assess if a new mobile application BeatClearWalker (BCW) intervention is practical, acceptable, and effectively used by people living with COPD. The app is designed to help people living with COPD attending PR adhere to their prescribed walking pace during exercise. The BCW app provides real-time, personalised music feedback through music degradation to optimise the dose of walking exercise.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Chronic Obstructive Lung Disease; Chronic Obstructive Airway Disease

Keywords

Auditory feedback; Chronic Obstructive Pulmonary Diseases; Digital Health Technology; Exercise; Exercise adherence; Pulmonary rehabilitation; Mobile applications

Outcome Measures

Primary Outcomes (5)

• The proportion of recruited participants who do not use the BCW app.

  Post PR 6-8 weeks.

• The proportion of recruited participants who complete the follow-up assessment.

  Upon the completion of the PR programme at 6-8 weeks.

• The proportion of patients who meet the eligibility criteria.

  The percentage of eligible from those who were screened against the eligibility criteria

  11 months

• The proportion of individuals with COPD who express interest in participating in the study.

  11 months

• The proportion of eligible participants who provide consent to enrol.

  After meeting the eligibility criteria at the screening stage.

  11 months

Secondary Outcomes (15)

• Medical Research Council (MRC) Dyspnoea Scale

  Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).

• Generic Health Status Questionnaire (EQ-5D-5L)

  Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).

• Generalized Anxiety Disorder 2-item (GAD-2)

  Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).

• Generalized Anxiety Disorder 7-item (GAD-7)

  Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).

• Walking exercise time at an individually prescribed cadence over the total time spent in walking exercise (Percent).

  Data collected after each walking exercise session during the PR programme (6-8 weeks).

Study Arms (1)

Music Walking Application BeatClearWalker (BCW)

EXPERIMENTAL

As it is a single-arm feasibility study, all participants will be allocated to one arm, receiving routine personalised walking exercise while listening to music from the smartphone using the music walking application BeatClearWalker during their Pulmonary rehabilitation Programme.

Device: Music walking application BeatClearWalker (BCW)

Interventions

Music walking application BeatClearWalker (BCW) DEVICE

The music walking application (BCW) is a smartphone application that can monitor the walking pace and allow individuals to listen to music and give immediate feedback so they can correct their walking pace to match their target walking speed, as prescribed by the healthcare professional. The application provides real-time audio feedback in the form of music; the music sound quality will reduce whenever the walking speed drops below or exceeds the participant\'s target walking speed. Simply, the application will work to supervise service users while exercising walking. The investigators are trying to assess the feasibility of this application with service users during their Pulmonary Rehabilitation programme (at the hospital/ home) to find out how participants interact with listening to music while exercise walking and how well they're able to keep to their target speed.

Music Walking Application BeatClearWalker (BCW)

Eligibility Criteria

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

You may qualify if:

• Willing and able to provide informed consent for participation in the study.
• The patient is referred for PR at the UHL.
• The patient has a confirmed diagnosis of COPD using spirometry (based on GOLD criteria)
• Male or female, aged 18+ years.
• Able to communicate in written and spoken English.

You may not qualify if:

• Unable to provide valid informed consent.
• Lack of motivation to participate in PR programme.
• Any-contra-indications absolute or relative to exercise training.
• Has had a cardiac event within last 6 weeks
• Severe psychiatric disorders
• Patients with a history of MRSA +ve screens (patients can be assessed and given an exercise programme but cannot attend the classes. Patients need to have 3 consecutive -ve MRSA swabs before they can attend).
• Unable to understand written or spoken English.

Sponsors & Collaborators

• University of Leicester: lead
• University of Strathclyde: collaborator
• University Hospitals, Leicester: collaborator

Study Sites (2)

NIHR Leicester Biomedical Research Centre - Respiratory

Leicester, Leicestershire, LE3 9QP, United Kingdom

NOT YET RECRUITING

University Hospitals of Leicester (UHL)

Leicester, Leicestershire, LE3 9QP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Orme, PhD

  University of Leicester

  PRINCIPAL INVESTIGATOR

• Linzy Houchen-Wolloff, PhD

  NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust

  STUDY DIRECTOR

• Sally J Singh, PhD

  NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust

  STUDY CHAIR

Central Study Contacts

Omar Alhothaly, MSc

CONTACT

+441162502758; oaea3@leicester.ac.uk

Mark Orme, PhD

CONTACT

mwo4@leicester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 8, 2024
• Study Start: April 20, 2025
• Primary Completion: September 12, 2025
• Study Completion: September 26, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)