Clinical trial NCT06732869: Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation
Official title: PACE - Physical Activity in COPD Using E-Health: Effectiveness of a Personalised eHealth Platform Integrated Into Pulmonary Rehabilitation to Increase Physical Activity in Patients With COPD - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Physical Activity
Keywords: physical activity
COPD
eHealth
pulmonary rehabilitation
Lead sponsor: Instituto Politécnico de Leiria
Sponsor class: OTHER
Collaborators: name: Unidade Local de Saúde do Baixo Mondego
name: Unidade Local de Saúde de Lisboa Norte
name: Faculdade de Motricidade Humana de Lisboa
First posted: 2024-12-13
Enrollment: 57
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). All participants will attend the pulmonary rehabilitation program for 2 months; the experimental group will receive a physical activity coaching intervention at the end of the 1st month of the rehabilitation program, which will continue for 6 months following the completion of the program. Assessments will be conducted at the beginning, midway, and at the end of the coaching program, as well as 3 months and 6 months after its conclusion.

Detailed description: This randomized controlled trial aims to evaluate the efficacy of a physical activity coaching intervention - delivered through an eHealth platform, both during and after pulmonary rehabilitation - to enhance physical activity levels and health-related outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD).

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.

Eligibility criteria: Inclusion criteria:

* age \> 40 years old
* 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:

* simultaneous participation in another behavioural modification program
* 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.

Primary outcomes:
measure: Accelerometry (number of daily steps)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Secondary outcomes:
measure: 6-Minute Walk Test (exercise capacity)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
measure: modified Medical Research Council (Dyspnoea)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
measure: Checklist of Individual Strength (Fatigue)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
measure: COPD Assessment Test (Impact of symptoms on health status)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
measure: MOS Short-Form Health Survey 36 Item v2 (SF-36) (Quality of Life)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
measure: Physical Exercise Self-Efficacy Scale (self-efficacy for PA)
timeFrame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
Other outcomes:
Locations:
city: Leiria
country: Portugal
facility: Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria
Study officials:
affiliation: Center for Innovative Care and Health Technology, Polytechnic of Leiria
name: Sofia Flora, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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