Effectiveness of a Physical ACtivity Coaching Intervention Using E-Health for COPD Patients in Pulmonary Rehabilitation (PACE)

Instituto Politécnico de Leiria

Status: Enrolling

Conditions: Physical Activity; COPD

Treatments: Behavioral: eHealth physical activity coaching intervention; Behavioral: pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06732869

UIDB/05704/2020 (Other Grant/Funding Number)

ciTechCare_PhD_SF

doi.org/10.54499/2020.06954.BD (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

57 participants in 2 patient groups

Experimental Group - Pulmonary rehabilitation + eHealth physical activity coaching intervention

Experimental group

Description:

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.

Treatment:

Behavioral: pulmonary rehabilitation

Behavioral: eHealth physical activity coaching intervention

Control group - pulmonary rehabilitation

Other group

Description:

Patients will attend pulmonary rehabilitation program for 10 weeks.

Treatment:

Behavioral: pulmonary rehabilitation