Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
ID07394712

Comprehensive Maintenance Program for COPD: The NAPOLEON Project in Lleida

Led by Institut de Recerca Biomèdica de Lleida · Updated on 2026-02-06

86

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of a supervised, multidimensional maintenance pulmonary rehabilitation program (PRP) on adults with chronic obstructive pulmonary disease (COPD) who have completed an initial 8-week rehabilitation program. The trial aims to evaluate how this maintenance program impacts symptoms like breathlessness and fatigue, quality of life, exercise capacity, healthcare use, economic benefits, and patient perceptions over a 12-month period. The study is a randomized controlled trial with two groups and multiple follow-up assessments. Participants in the intervention group will attend a three-month maintenance program that includes two supervised exercise sessions per week and six monthly educational sessions covering COPD management, healthy lifestyle habits, and early detection of exacerbations. These sessions are conducted at a comprehensive health center by a physiotherapist. The control group will receive standard physical activity advice and a home exercise plan without supervised sessions but will be monitored similarly throughout the study. Participants will be evaluated at baseline, 3, 6, and 12 months for respiratory symptoms, quality of life, functional capacity, mental health, physical activity, sleep-wake patterns, and healthcare resource use. Pulmonary function tests and body measurements will be done at the start and end of the study. Sleep patterns will be tracked continuously using wearable devices. Researchers will measure adherence to the program and analyze healthcare costs and cost-effectiveness. Safety is monitored throughout, and any adverse events will be reported and managed accordingly.

CONDITIONS

Brief Title

Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 40 to 75 years
  • Confirmed moderate to severe COPD diagnosis
  • Clinically stable for at least 4 weeks after last severe exacerbation
  • Referred to outpatient pulmonary rehabilitation for persistent symptoms and moderate to severe dyspnea (MRC score > 2)
  • Completed at least 6 out of 8 sessions of an initial 8-week pulmonary rehabilitation program
Not Eligible

You will not qualify if you...

  • Medical conditions that prevent safe physical exercise, including unstable cardiovascular disease, severe musculoskeletal or neurological disorders, recent surgery, or acute medical conditions
  • Severe cognitive impairment limiting participation
  • Unstable psychiatric disorders affecting adherence
  • Unavailability or refusal to attend community exercise sessions
  • Participation in another pulmonary rehabilitation program within 6 months prior to enrollment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants assigned to the intervention group attend a supervised multidimensional pulmonary rehabilitation maintenance program consisting of twice-weekly exercise sessions and six educational sessions over three months. The control group follows general physical activity recommendations with unsupervised home exercise.

Biweekly supervised exercise sessions and twice-monthly educational sessions for intervention group

Follow-up

Duration - 12 months total including treatment period

Participants are monitored with clinical evaluations at baseline, 3, 6, and 12 months to assess symptoms, quality of life, functional capacity, mental health, physical activity, sleep-wake patterns, and healthcare utilization.

4 clinical assessment visits at baseline, 3, 6, and 12 months

Trial Site Locations

Total: 2 locations

1

Arnau de Vilanova University Hospital

Lleida, Catalonia, Spain, 25198

Actively Recruiting

2

Arnau de Vilanova University Hospital

Lleida, Spain

Actively Recruiting

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Research Team

J

Jessica G MD, PhD, MD, PhD

F

Ferran Barbé, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Minimal Clinically Important Differences and Feasibility of Dyspnea-12 and the Multidimensional Dyspnea Profile in Cardiorespiratory Disease.

Magnus P Ekström, Hans Bornefalk, C Magnus Sköld...

https://pubmed.ncbi.nlm.nih.gov/32512047

Validity Study of Catalan, Galician and Basque Language Versions of the COPD Assessment Test and Equivalence With the Spanish Version.

Alvar Agustí, Alberto Fernández-Villar, Alberto Capelastegui...

https://pubmed.ncbi.nlm.nih.gov/27986409