Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation
NCT ID: NCT06732869
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
57 participants
INTERVENTIONAL
2024-12-02
2025-06-30
Brief Summary
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Detailed Description
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All participants will attend the pulmonary rehabilitation program for 10 weeks. At week 5 of the rehabilitation program, the experimental group will receive a physical activity coaching intervention, which will continue for 6 months following its completion. This intervention will include an eHealth platform divided into two applications (a mobile app for patients and a web app for researchers/healthcare professionals).
Goal setting and progression according to patients' performance and willingness to increase will occur every week, through phone calls. Barriers to physical activity and strategies to overcome them will be identified between the patient and researcher, during the goal-setting moments. Notifications about PA goals achievement and incentives will be sent to patients during the intervention.
The assessment moments will be conducted at the beginning, midway, and end of the pulmonary rehabilitation program, as well as 3- and 6 months after its conclusion.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention
Patients will attend a PR program for 10 weeks and receive an eHealth PA coaching intervention (smartband connected to a mobile application) in the week 5 of PR until months after end of PR.
eHealth physical activity coaching intervention
Patients will attend a PR program and in week 5 of PR will receive an eHealth PA coaching intervention until 6 months after end of PR. The PA goals will be prescribed through a phone call and the personalisation of goal prescription will be based on an algorithm considering patient's performance in the previous week, perceived easiness of achieving the previous goal and confidence to change it. If patient does not achieve the goal, reasons, barriers to PA and strategies to overcome them will be identified. Patients will receive a daily notification about their goal achievements, at 6PM every day, giving them the possibility to increase their PA to achieve the goal, if they have not reached it yet. Patients will also receive personalized notifications sent manually by the researcher whenever appropriate. PA goals will be prescribed on a weekly basis.
pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.
Control group - pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks.
pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.
Interventions
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eHealth physical activity coaching intervention
Patients will attend a PR program and in week 5 of PR will receive an eHealth PA coaching intervention until 6 months after end of PR. The PA goals will be prescribed through a phone call and the personalisation of goal prescription will be based on an algorithm considering patient's performance in the previous week, perceived easiness of achieving the previous goal and confidence to change it. If patient does not achieve the goal, reasons, barriers to PA and strategies to overcome them will be identified. Patients will receive a daily notification about their goal achievements, at 6PM every day, giving them the possibility to increase their PA to achieve the goal, if they have not reached it yet. Patients will also receive personalized notifications sent manually by the researcher whenever appropriate. PA goals will be prescribed on a weekly basis.
pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks. Pulmonary rehabilitation is evidence-based multidisciplinary intervention based on thorough patient assessment followed by patient-tailored therapies that include, but are not limited to exercise training, education, self-management intervention aiming at behaviour change, known to improve health status and psychological well-being, reducing dyspnoea and healthcare utilization and hospitalization. In this study, pulmonary rehabilitation programs will have 20 sessions, twice a week, including exercise training (aerobic and strength training), educational sessions about topics as medication, smoking cessation, energy conservation techniques, physical activity, stress and anxiety management, breathing control, inhaled therapy and nutrition; nutritional and psychosocial counselling. Education session about PA importance and recommendations will be also provided in both arms.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of COPD according to GOLD criteria, clinically stable (i.e., with no exacerbations in the previous month)
* being enrolled in a pulmonary rehabilitation program
* having a smartphone with access to the internet
* being able to understand and provide informed consent.
Exclusion Criteria
* having any clinical condition that precludes participation in a PA intervention (e.g., severe musculoskeletal or neurological disorders and unstable cardiovascular disease)
* another primary respiratory disease
* history of recent neoplasia (including last treatment) in the previous year.
40 Years
ALL
No
Sponsors
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Unidade Local de Saúde do Baixo Mondego
UNKNOWN
Unidade Local de Saúde de Lisboa Norte
UNKNOWN
Faculdade de Motricidade Humana de Lisboa
UNKNOWN
Instituto Politécnico de Leiria
OTHER
Responsible Party
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Sofia Flora
Principal Investigator
Principal Investigators
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Sofia Flora, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Center for Innovative Care and Health Technology, Polytechnic of Leiria
Locations
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Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria
Leiria, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Maria Guarino
Role: primary
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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doi.org/10.54499/2020.06954.BD
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UIDB/05704/2020
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ciTechCare_PhD_SF
Identifier Type: -
Identifier Source: org_study_id