Chronic Obstructive Pulmonary Disease Access and Adherence to Pulmonary Rehabilitation Intervention (CAPRI): Protocol for a randomized controlled trial and adaptations during the COVID-19 pandemic.
Chronic obstructive pulmonary disease
Daily step count
Pedometer
Physical activity
Protocol
Pulmonary rehabilitation
Web-based
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
06 2023
06 2023
Historique:
received:
08
02
2023
accepted:
17
04
2023
medline:
29
5
2023
pubmed:
22
4
2023
entrez:
21
04
2023
Statut:
ppublish
Résumé
Pulmonary rehabilitation (PR) is the standard of care for chronic obstructive pulmonary disease (COPD) management. However, significant barriers limit access and adherence to PR and alternatives are needed. The purpose of this randomized controlled trial is to test the efficacy of a web-based, pedometer-mediated intervention to increase physical activity (PA) for persons with COPD who decline PR or meet U.S. guidelines for referral to PR but have not participated (CAPRI-1). In addition, we will test whether the intervention maintains PA following PR in an exploratory aim (CAPRI-2). Participants with COPD (N = 120) will be recruited and randomized 1:1 to a 12-week web-based, pedometer-mediated intervention or usual care (UC) (CAPRI-1). The intervention provides: 1) objective monitoring of walking and iterative feedback, 2) individualized step-count goals, 3) motivational messages and educational content, and 4) an online community. The primary outcome is change in daily step count from baseline to 12 weeks. Secondary outcomes include: (a) exercise capacity; (b) self-reported PA; (c) PA intensity; (d) exercise self-regulatory efficacy, (e) health-related quality of life, (f) dyspnea, (g) depression symptoms, and (h) healthcare utilization. CAPRI-2 will test whether participants (N = 96) assigned to the intervention following PR completion show greater maintenance of daily step count compared to UC at 3, 6, 9, and 12 months. If the intervention is efficacious, it may be an alternative for those who cannot attend PR or a maintenance program following completion of conventional PR. We also present adaptations made to the protocol in response to the COVID-19 pandemic.
Sections du résumé
BACKGROUND
Pulmonary rehabilitation (PR) is the standard of care for chronic obstructive pulmonary disease (COPD) management. However, significant barriers limit access and adherence to PR and alternatives are needed. The purpose of this randomized controlled trial is to test the efficacy of a web-based, pedometer-mediated intervention to increase physical activity (PA) for persons with COPD who decline PR or meet U.S. guidelines for referral to PR but have not participated (CAPRI-1). In addition, we will test whether the intervention maintains PA following PR in an exploratory aim (CAPRI-2).
METHODS
Participants with COPD (N = 120) will be recruited and randomized 1:1 to a 12-week web-based, pedometer-mediated intervention or usual care (UC) (CAPRI-1). The intervention provides: 1) objective monitoring of walking and iterative feedback, 2) individualized step-count goals, 3) motivational messages and educational content, and 4) an online community. The primary outcome is change in daily step count from baseline to 12 weeks. Secondary outcomes include: (a) exercise capacity; (b) self-reported PA; (c) PA intensity; (d) exercise self-regulatory efficacy, (e) health-related quality of life, (f) dyspnea, (g) depression symptoms, and (h) healthcare utilization. CAPRI-2 will test whether participants (N = 96) assigned to the intervention following PR completion show greater maintenance of daily step count compared to UC at 3, 6, 9, and 12 months.
DISCUSSION
If the intervention is efficacious, it may be an alternative for those who cannot attend PR or a maintenance program following completion of conventional PR. We also present adaptations made to the protocol in response to the COVID-19 pandemic.
Identifiants
pubmed: 37084881
pii: S1551-7144(23)00126-X
doi: 10.1016/j.cct.2023.107203
pmc: PMC10113592
pii:
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
107203Subventions
Organisme : RRD VA
ID : IK2 RX003527
Pays : United States
Organisme : RRD VA
ID : I01 RX002855
Pays : United States
Informations de copyright
Published by Elsevier Inc.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.