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Pulmonary Rehabilitation Frequency in COPD Patients

4. maj 2026 opdateret af: Claudia de la Fuente Escudero, Hospital Universitario Fundación Alcorcón

Comparative Efficacy of a Supervised Pulmonary Rehabilitation Program Performed 3 Days/Week Versus 1 Day/Week in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomized Clinical Trial

Chronic obstructive pulmonary disease (COPD) is a common condition that can cause breathlessness and reduced physical capacity. Pulmonary rehabilitation (PR) is an effective treatment, but traditional programs often require patients to attend sessions several times per week, which may limit participation.

This study aims to compare the effectiveness of two supervised pulmonary rehabilitation programs: one performed 3 days per week and another performed 1 day per week, both over an 8-week period and including additional home-based exercises.

The main objective is to determine whether the lower-frequency program is not inferior to the higher-frequency program in improving functional capacity, measured by the six-minute walk test. Secondary outcomes include dyspnea, quality of life, muscle strength, physical activity, adherence, exacerbations, and safety.

The results of this study may help optimize pulmonary rehabilitation programs and improve accessibility for patients with COPD.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a randomized, parallel-group clinical trial designed to evaluate the non-inferiority of a supervised pulmonary rehabilitation (PR) program performed once weekly compared with a program performed three times weekly in patients with stable chronic obstructive pulmonary disease (COPD).

Participants will be recruited from a tertiary care hospital and randomly assigned to one of two intervention groups: (1) supervised PR three days per week or (2) supervised PR one day per week. Both interventions will be conducted over 8 weeks and will include structured exercise training and educational components, complemented by a home-based program.

The primary outcome is functional capacity assessed by the six-minute walk test. Secondary outcomes include dyspnea, health-related quality of life, peripheral muscle strength, physical activity levels, adherence to the intervention, incidence of exacerbations, and safety.

Statistical analyses will be conducted according to both intention-to-treat and per-protocol principles. A non-inferiority framework will be applied, and appropriate mixed-effects models will be used to assess differences between groups over time.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

158

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

IInclusion criteria

  • Diagnosis of COPD confirmed by spirometry (FEV₁/FVC <0.70)
  • Modified Medical Research Council (mMRC) dyspnoea scale ≥2
  • Ability to actively participate and perform physical exercise
  • Signed informed consent

Exclusion criteria

  • Unstable cardiac or musculoskeletal comorbidity contraindicating or limiting exercise
  • Moderate to severe cognitive impairment or inability to understand instructions
  • Recent participation (<6 months) in a complete pulmonary rehabilitation programme
  • Inability to attend the centre 1-3 days/week according to group allocation
  • Current participation in any structured pulmonary rehabilitation programme or supervised rehabilitation intervention in another centre.
  • Active oncological treatment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pulmonary Rehabilitation 3 Days/Week
Participants receive supervised pulmonary rehabilitation three times per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
Adfærdsmæssigt: Pulmonary Rehabilitation
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
Eksperimentel: Pulmonary Rehabilitation 1 Day/Week
Participants receive supervised pulmonary rehabilitation once per week for 8 weeks, including exercise training and educational components, complemented by a home-based program.
Adfærdsmæssigt: Pulmonary Rehabilitation
Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional capacity assessed by the six-minute walk test (6MWT)
Tidsramme: Change from baseline to 8 weeks (end of intervention)
Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters.
Change from baseline to 8 weeks (end of intervention)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximal inspiratory pressure (MIP)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O.
Change from baseline to 8, 12, and 24 weeks
Maximal expiratory pressure (MEP)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O.
Change from baseline to 8, 12, and 24 weeks
Quadriceps muscle strength
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.
Change from baseline to 8, 12, and 24 weeks
Five-times sit-to-stand test (5STS)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds.
Change from baseline to 8, 12, and 24 weeks
One-minute sit-to-stand test (1-min STS)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Functional capacity assessed by the number of repetitions completed in one minute.
Change from baseline to 8, 12, and 24 weeks
Dyspnea assessed by the modified Medical Research Council (mMRC) scale
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea).
Change from baseline to 8, 12, and 24 weeks
COPD Assessment Test (CAT)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status).
Change from baseline to 8, 12, and 24 weeks
Short Form-36 Health Survey (SF-36)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Health-related quality of life assessed using the SF-36 questionnaire across multiple domains.
Change from baseline to 8, 12, and 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Tidsramme: Change from baseline to 8, 12, and 24 weeks
Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms).
Change from baseline to 8, 12, and 24 weeks
Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
Tidsramme: At 8 and 24 weeks
Physical activity levels assessed using the IPAQ questionnaire.
At 8 and 24 weeks
Adherence to pulmonary rehabilitation program
Tidsramme: During the 8-week intervention period
Adherence defined as the percentage of attended supervised sessions.
During the 8-week intervention period
COPD exacerbations
Tidsramme: Up to 24 weeks
Number of COPD exacerbations during follow-up.
Up to 24 weeks
Emergency department visits and hospital admissions
Tidsramme: Up to 24 weeks
Number of COPD-related emergency visits and hospital admissions.
Up to 24 weeks
Adverse events
Tidsramme: During the 8-week intervention and follow-up up to 24 weeks
Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls.
During the 8-week intervention and follow-up up to 24 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospital Universitario Fundación Alcorcón

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

1. januar 2028

Studieafslutning (Anslået)

1. august 2028

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HUFAlcorcon

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