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Is it possible to predict a worsening of lung disease symptoms using wearable technology measuring heart rate, breathing rate, skin temperature and physical activity?

SYMPHONY (SYMptoms and PHysiology to Observe and uNderstand activitY): Using continuous, passive, non-invasive wearable technology to understand the interactions between physiology, behaviour, the environment and exacerbations of chronic obstructive pulmonary disease (COPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12855961
Enrollment
100
Registered
2019-03-27
Start date
2018-01-15
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease (COPD)

Interventions

This prospective study has two groups
patients admitted for an acute exacerbation of COPD (acute group) and patients with stable disease (Stable group). The acute group will be recruited from hospital wards following admission for an acut

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Acute group: 1. Willing and able to give informed consent for participation in the study 2. Aged =40 years 3. Medical Research Council (MRC) grade 2-5 when stable 4. Able (in the opinion of the COPD Specialist Nurses) and willing to comply with all study requirements Stable group: 1. Willing and able to give informed consent for participation in the study 2. Aged =40 years 3. Confirmed diagnosis of COPD 4. Medical Research Council (MRC) grade 2-5 when stable 5. Attendance to pulmonary rehabilitation assessment visit 6. Able (in the opinion of the Pulmonary Rehabilitation assessor) and willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: All participants: 1. Female participants who are pregnant or lactating 2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study 3. Unable or unwilling to comply with study requirements 4. Inability to take part in light intensity physical activity due to significant mobility issues (e.g. neurological/musculoskeletal disorder) Acute group only: 1. Diagnosis of any other chronic respiratory condition as the primary cause of their hospital admission

Design outcomes

Primary

MeasureTime frame
Associations between the following will be assessed daily throughout the study: 1. Physical activity, assessed using daily summary data from the wearable technology 2. Physiology, assessed using daily summary data from the wearable technology 3. Environmental data, obtained from the Met Office 4. Symptoms, assessed using the EXACT-PRO daily diary

Secondary

MeasureTime frame
1. Feasibility of the wearable technology, assessed by qualitative interviews and field notes during fortnightly phone calls and at the follow-up appointment 2. Acceptability of the wearable technology, assessed by qualitative interviews, field notes and adherence to wearing and charging the device 3. Dyspnea, assessed using the Medical Research Council (MRC) dyspnea scale at the baseline and follow-up 4. Knowledge of COPD, assessed using the Bristol Knowledge Questionnaire at the baseline and follow-up 5. Depression and anxiety, assessed using the Hospital Anxiety and Depression Scale (HADS) at the baseline and follow-up 6. Impact of COPD, assessed using the COPD Assessment Test (CAT) at the baseline and follow-up 7. Health-related quality of life, assessed using the Chronic Respiratory Disease Questionnaire (CRQ) at the baseline and follow-up 8. Cognitive impairment, assessed using the Montreal Cognitive Assessment (MoCA) at the baseline and follow-up 9. Breathlessness, assessed using the Multidimensional Dyspnoea Profile at the baseline and follow-up 10. Balance, ability to rise from a chair and 4 metre walking speed, assessed using the Short Physical Performance Battery (SPPB) at the baseline and follow-up 11. Waist circumference, assessed by staff at the baseline and follow-up

Countries

England, United Kingdom

Contacts

Public ContactMark Orme

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 18, 2026