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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Accelerometry (number of daily steps)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: eHealth physical activity coaching intervention (Behavioral)
Control group - pulmonary rehabilitation
Patients will attend pulmonary rehabilitation program for 10 weeks.
Intervention: pulmonary rehabilitation (Behavioral)
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.
Intervention: pulmonary rehabilitation (Behavioral)
Outcomes
Primary Outcomes
Accelerometry (number of daily steps)
Time Frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion
PA will be objectively measured using the triaxial accelerometer Actigraph GT3X+, already validated in COPD. Patients will be instructed to wear the accelerometer for 7 days on the dominant side of their waist, held by an elastic strap, during waking hours, except for bathing or swimming. A valid day will be defined as a minimum of 8 hours of wearing time, and patients will need to have at least 4 valid days in each moment of data collection. Accelerometer-based data will be then downloaded and analysed using the algorithms of Freedson (1998) with 60-s epoch: daily time (in min) spent in light-intensity PA, moderate, vigorous and a combination of both. The number of steps per day and per week will also be collected, being the main outcome of the study.
Secondary Outcomes
- 6-Minute Walk Test (exercise capacity)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
- modified Medical Research Council (Dyspnoea)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
- Checklist of Individual Strength (Fatigue)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
- COPD Assessment Test (Impact of symptoms on health status)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
- MOS Short-Form Health Survey 36 Item v2 (SF-36) (Quality of Life)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
- Physical Exercise Self-Efficacy Scale (self-efficacy for PA)(weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion)
Investigators
Sofia Flora
Principal Investigator
Instituto Politécnico de Leiria