An interventional study of Music walking application BeatClearWalker (BCW) in Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Lung Disease and Chronic Obstructive Airway Disease, sponsored by University of Leicester. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by University of Leicester · Not applicable, Interventional, and Health services research
Among 12 studies in Pulmonary Disease, Chronic Obstructive by University of Leicester — 5 open to participants now, 5 under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · University of Leicester.
Among the 12 studies in Pulmonary Disease, Chronic Obstructive by University of Leicester, this one is the only one that started in 2025, is one of 3 with no phase, and was the 11th registered.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →5 of the 12 studies in Pulmonary Disease, Chronic Obstructive by University of Leicester are open now, in 1 country. Each count lists the studies.
Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2025.
Median enrollment 80 across the 5 interventional studies, 160 across the 7 observational. Of the 6 that completed or were terminated, 3 (50%) have results posted.
University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.
1 of the studies in Pulmonary Disease, Chronic Obstructive by University of Leicester that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07500948University of LeicesterEffectiveness of Pollution Monitoring in Clinical Exercise Rehabilitation | 2027-03-31 |
Among the 12 studies in Pulmonary Disease, Chronic Obstructive by University of Leicester, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
The proportion of recruited participants who do not use the BCW app.
Time frame: Post PR 6-8 weeks.
The proportion of recruited participants who complete the follow-up assessment.
Time frame: 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
Time frame: 11 months
The proportion of individuals with COPD who express interest in participating in the study.
Time frame: 11 months
The proportion of eligible participants who provide consent to enrol.
After meeting the eligibility criteria at the screening stage.
Time frame: 11 months
Medical Research Council (MRC) Dyspnoea Scale
Medical Research Council (MRC) Dyspnoea Scale , measuring the level of breathlessness. Scale: Minimum value: 1 Maximum value: 5. The higher the score, the worse the outcome (breathlessness).
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Generic Health Status Questionnaire (EQ-5D-5L)
The EQ-5D-5L evaluates generic health status, with five dimensions of health assessed. Scale: The descriptive system results in a single score; higher scores generally indicate worse outcomes.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Generalized Anxiety Disorder 2-item (GAD-2)
The Generalized Anxiety Disorder-2 (GAD-2) is a brief screening tool for generalized anxiety disorder, measuring the frequency of anxiety symptoms over the past two weeks. Scale: Minimum score is 0, and Maximum score is 6. Higher scores indicate worse anxiety symptoms. A score of 3 points is the preferred cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Generalized Anxiety Disorder 7-item (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item scale that measures the severity of generalized anxiety disorder symptoms over the past two weeks. Scale: The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Time frame: 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 of the walking exercise will be collected during PR from BCW exercise log.
Time frame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
Walking exercise time below the individually prescribed cadence. (Percent)
Data of the walking exercise will be collected during PR from BCW exercise log.
Time frame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
The proportion of time spent walking over the prescribed walking exercise duration as measured during the Endurance Shuttle Walking test. (Percent)
Data will be collected after each walking exercise session during PR from BCW exercise log.
Time frame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
Exercise Adherence Rating Scale (EARS).
It will assess the adherence levels of individuals to their exercise prescription. Scale: The score range, 0 to 24. Higher scores generally indicate better adherence (24 indicates best adherence). The scale will be used post pulmonary rehabilitation programme
Time frame: Follow-up (Post-PR, at 6-8 weeks).
Walking exercise time above the prescribed cadence. (Percent)
Data of the walking exercise will be collected during PR from BCW exercise log.
Time frame: Data collected after each walking exercise session during the PR programme (6-8 weeks).
Exercise Capacity test (Incremental Shuttle Walking test [ISWT])
Incremental Shuttle Walking Test, Distance walked in meters
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Exercise Capacity (Endurance Shuttle Walking test [ESWT])
Endurance Shuttle Walking Test (ESWT), Time walked in seconds.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depression based on 9 criteria over the past 2 weeks. Scale: Minimum score: 0, Maximum score: 27. Higher scores indicate more severe depressive symptoms. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
CRQ-SR (Chronic Respiratory Questionnaire - Self-Reported)
Chronic Respiratory Questionnaire - Self-Reported (CRQ-SR) measures quality of life in individuals with chronic respiratory diseases. Scale: Minimum and maximum values vary by subscale. Higher scores indicate better health-related quality of life.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Patient Health Questionnaire-2 (PHQ-2)
The Patient Health Questionnaire-2 (PHQ-2) measures the frequency of depressed mood and anhedonia over the past 2 weeks. Scale: A PHQ-2 score ranges from 0-6. A score of 3 as the optimal cutpoint when using the PHQ-2 to screen for depression. If the score is 3 or greater, major depressive disorder is likely.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) evaluates the impact of COPD on the individual life. Scale: Minimum score: 0, Maximum score: 40. Higher scores indicate worse health status.
Time frame: Baseline (Pre-PR) and Follow-up (Post-PR, at 6-8 weeks).
Plan to share: No
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Start is estimated for Apr 2025; primary completion for Sep 2025, 4 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 4 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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