Clinical trial NCT06629675: Make Every Step Count: Personalised Music Feedback to Walking for People Living With COPD
Official title: Personalised Music Feedback to Optimise Adherence to the Walking Exercise Prescription During Pulmonary Rehabilitation for Individuals Living With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: University of Strathclyde
name: University Hospitals, Leicester
First posted: 2024-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Previous research has shown that adherence to the prescribed walking exercise intensity is challenging for individuals with COPD and that methods to provide further support are needed. Using activity monitors and trackers to give feedback can increase the walking exercise participation of people living with COPD. However, it has been reported that more than half of steps taken during exercise were below the prescribed pace. It is possible to individually prescribe exercise intensity by deriving cadence (steps taken per minute) from the ISWT and ESWT using activity monitor. Furthermore, activity monitors have been used to measure level of adherence to the intensity of the prescribed walking exercise prescriptions in the context of PR and chronic respiratory diseases.

Listening to music in daily life can decrease stress and improve the psychological well-being. Implementing music to enhance exercise performance has been utilised with different populations. Auditory feedback in the form of listening to music is one example where exercising to music can be utilised as distraction from fatigue perception or used as a motivational tool to exercise in a healthy population. Previous studies have investigated the effect of listening to music while exercising at different intensities and music tempos on fatigue perception and have shown a positive effect in decreasing the perception of fatigue. In addition, the effect of choosing the preferred versus non-preferred music genre on repeated sprints showed significant improvement in motivation to exercise and lower perceived exertion rates in the preferred music genre group. Similarly, in COPD, listening to music as distractive auditory stimuli while exercising decreases breathlessness and fatigue symptoms resulting in increased aerobic capacity and HRQOL. In another study, individuals with COPD who listened to music while performing high-intensity exercise, showed a reduction in dyspnoea, which was associated with higher tolerance of high-intensity exercise as measured by endurance time. The findings of a previous study showed that participants who listened to music can perform significantly more exercise compared to participants who listened to grey noise or silence. Paced walking to music with COPD participants showed significant improvement in dyspnoea, exercise tolerance, HRQoL and fatigue. In the context of unsupervised walking exercise among individuals living with COPD, paced walking to interval beeps sound as such in metronomes to maintain the walking exercise intensity had been investigated previously. In a prospective observational clinical trial, the effect of home-based PR on exercise capacity and HRQoL using paced walking to metronome was investigated. The results showed improvements in maximal exercise capacity (six minute walk test: 6MWT) and HRQoL (SGRQ). However, the constant rhythm such as in metronome style feedback may not be interesting overtime which can make walking exercises less engaging and lead to reduced motivation for long-term adherence.

Combining the effect of paced walking when listening to 'metronome style' feedback and preferred music to support walking exercise might offer a more enjoyable way to coach people living with COPD to walk for exercise at their prescribed intensity. This principle has been investigated in adult without reported diseases population using a mobile application (app), the BeatClearWalker (BCW), as shown in the link (https://youtu.be/MLy4GA8_eUc?si=oQL3mklA2bRKbnQl). The BCW is a fitness smartphone application that monitors walking cadence and helps individuals to walk at their individually-prescribed cadence and maintain that cadence. The app is designed to work on smartphones run by Android software only. Despite a considerable number of fitness applications that monitor walking distance, this is the first application designed to support walking and provide real-time feedback about cadence through music sound quality. The application allows service users to listen to any music while walking and apply dynamic live audio feedback to help individuals to walk at and maintain the pre-set individualised target walking cadence which can be entered on the application. The real-time, hands-free audio feedback is noticeable and designed to disrupt the quality of the played music. The feedback comes in two forms: (1) clear music, similar when listening to any typical music played in streaming music player or (2) degradation of music audio quality. The music will play without effect if the individuals walk at or above their targeted cadence. Once the walking cadence drops below the targeted, the quality of the music will be degraded and will return to normal once the individual reaches the targeted cadence again.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The proportion of recruited participants who do not use the BCW app.
timeFrame: Post PR 6-8 weeks.
measure: The proportion of recruited participants who complete the follow-up assessment.
timeFrame: Upon the completion of the PR programme at 6-8 weeks.
measure: The proportion of patients who meet the eligibility criteria.
timeFrame: 11 months
measure: The proportion of individuals with COPD who express interest in participating in the study.
timeFrame: 11 months
measure: The proportion of eligible participants who provide consent to enrol.
timeFrame: 11 months
Secondary outcomes:
measure: Medical Research Council (MRC) Dyspnoea Scale
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Generic Health Status Questionnaire (EQ-5D-5L)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Generalized Anxiety Disorder 2-item (GAD-2)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Walking exercise time at an individually prescribed cadence over the total time spent in walking exercise (Percent).
timeFrame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
measure: Walking exercise time below the individually prescribed cadence. (Percent)
timeFrame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
measure: The proportion of time spent walking over the prescribed walking exercise duration as measured during the Endurance Shuttle Walking test. (Percent)
timeFrame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
measure: Exercise Adherence Rating Scale (EARS).
timeFrame: Follow-up (Post-PR, at 6-8 weeks).
measure: Walking exercise time above the prescribed cadence. (Percent)
timeFrame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
measure: Exercise Capacity test (Incremental Shuttle Walking test [ISWT])
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Exercise Capacity (Endurance Shuttle Walking test [ESWT])
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: CRQ-SR (Chronic Respiratory Questionnaire - Self-Reported)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
measure: COPD Assessment Test (CAT)
timeFrame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: NIHR Leicester Biomedical Research Centre - Respiratory
state: Leicestershire
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester (UHL)
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Mark Orme, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust
name: Linzy Houchen-Wolloff, PhD
role: STUDY_DIRECTOR
affiliation: NIHR Leicester Biomedical Research Centre - Respiratory, University Hospitals of Leicester NHS Trust
name: Sally J Singh, PhD
role: STUDY_CHAIR
References: