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

Not Applicable

Recruiting

• Conditions: COPD; Physical Activity

• Registration Number: NCT06732869
• Lead Sponsor: Instituto Politécnico de Leiria

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 Timeline

• Study First Submitted: 2024-11-27
• Status Verified: 2024-12
• Study Start: 2024-12-02
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-13
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accelerometry (number of daily steps)	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 Outcome Measures

Name	Time	Method
6-Minute Walk Test (exercise capacity)	weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion	Functional exercise capacity was measured using 6MWT, and predicted values were computed using the equation developed for Portuguese adults. The test will be conducted according to guidelines from ERS/ATS.
modified Medical Research Council (Dyspnoea)	weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion	Dyspnoea was assessed through the modified Medical Research Council (mMRC), on a scale from 0 to 4, in which 0 means 'dyspnoea only with strenuous exercise' and 4 means 'too dyspnoeic to leave house or breathless when dressing'.
Checklist of Individual Strength (Fatigue)	weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion	Fatigue will be assessed with the Checklist of Individual Strength (CIS20). This questionnaire consists of four dimensions (Subjective Fatigue, Concentration, Motivation and Physical Activity) that assess the fatigue severity.
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	The COPD Assessment Test is designed to measure the impact of COPD on a person's life, and how this changes over time.The total score is a sum of the 8 questions. Higher scores indicates worse impact of the disease.
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	Quality of Life will be assessed with MOS Short-Form Health Survey 36 Item v2 (SF-36). The SF-36 is widely used to measure perceived health-related quality of life. The instrument includes scales for physical functioning, social functioning, limitations in function due to physical or emotional problems, mental health, energy, pain and general perception of health. The score ranges from 0 - 100 (higher scores indicate better levels of quality of life.
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	self-efficacy for PA will be assessed with Physical Exercise Self-Efficacy Scale which consists of 5 items that analyse an individual's confidence in performing physical exercise according to different emotional states (worried, depressed, nervous, tired and busy). The total score is the sum of the scores for each item, ranging from 5 to 20. The higher the score, the greater the belief or sense of self-efficacy for exercise.

Trial Locations

Locations (1)

Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria; 🇵🇹 Leiria, Portugal