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

Overview

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.

Interventions

• Behavioral 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
• Behavioral 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 rehabi

Primary outcome measures

• Accelerometry (number of daily steps) [Time frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion]

Secondary outcome measures (6)

• 6-Minute Walk Test (exercise capacity) [Time frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion]
• modified Medical Research Council (Dyspnoea) [Time frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 3- and 6-months after its conclusion]
• Checklist of Individual Strength (Fatigue) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: weeks 1, 5, 10 of pulmonary rehabilitation program and 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Portugal · 1 center

• Center for Innovative Care and Health Technology (ciTechCare), Polytechnic of Leiria — Leiria

Publications

• Global Strategy for the Diagnosis Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available from: https://goldcopd.org/2024-gold-report/. 2024.
• McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3. PMID 25705944
• Ding D, Lawson KD, Kolbe-Alexander TL, Finkelstein EA, Katzmarzyk PT, van Mechelen W, Pratt M; Lancet Physical Activity Series 2 Executive Committee. The economic burden of physical inactivity: a global analysis of major non-communicable diseases. Lancet. 2016 Sep 24;388(10051):1311-24. doi: 10.1016/S0140-6736(16)30383-X. Epub 2016 Jul 28. PMID 27475266
• Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Dec 8;12(12):CD005305. doi: 10.1002/14651858.CD005305.pub4. PMID 27930803
• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, B PMID 24127811
• Spruit MA, Pitta F, McAuley E, ZuWallack RL, Nici L. Pulmonary Rehabilitation and Physical Activity in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2015 Oct 15;192(8):924-33. doi: 10.1164/rccm.201505-0929CI. PMID 26161676
• Burge AT, Cox NS, Abramson MJ, Holland AE. Interventions for promoting physical activity in people with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2020 Apr 16;4(4):CD012626. doi: 10.1002/14651858.CD012626.pub2. PMID 32297320
• Wilson JJ, O'Neill B, Collins EG, Bradley J. Interventions to Increase Physical Activity in Patients with COPD: A Comprehensive Review. COPD. 2015 Jun;12(3):332-43. doi: 10.3109/15412555.2014.948992. Epub 2014 Sep 15. PMID 25221907

Identifiers

NCT: NCT06732869 · ciTechCare_PhD_SF · doi.org/10.54499/2020.06954.BD · UIDB/05704/2020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗