Pulmonary Rehabilitation Frequency in COPD Patients
2026년 5월 4일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
158
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
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실험적: 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.
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Supervised pulmonary rehabilitation program including exercise training and educational components, complemented by a home-based program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Functional capacity assessed by the six-minute walk test (6MWT)
기간: Change from baseline to 8 weeks (end of intervention)
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Functional capacity will be measured using the six-minute walk test (6MWT), expressed as distance walked in meters.
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Change from baseline to 8 weeks (end of intervention)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximal inspiratory pressure (MIP)
기간: Change from baseline to 8, 12, and 24 weeks
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Respiratory muscle strength assessed by maximal inspiratory pressure (MIP), expressed in cmH₂O.
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Change from baseline to 8, 12, and 24 weeks
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Maximal expiratory pressure (MEP)
기간: Change from baseline to 8, 12, and 24 weeks
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Respiratory muscle strength assessed by maximal expiratory pressure (MEP), expressed in cmH₂O.
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Change from baseline to 8, 12, and 24 weeks
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Quadriceps muscle strength
기간: Change from baseline to 8, 12, and 24 weeks
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Peripheral muscle strength assessed by quadriceps dynamometry, expressed in Newtons.
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Change from baseline to 8, 12, and 24 weeks
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Five-times sit-to-stand test (5STS)
기간: Change from baseline to 8, 12, and 24 weeks
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Functional lower limb performance assessed by the time required to complete five sit-to-stand repetitions, expressed in seconds.
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Change from baseline to 8, 12, and 24 weeks
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One-minute sit-to-stand test (1-min STS)
기간: Change from baseline to 8, 12, and 24 weeks
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Functional capacity assessed by the number of repetitions completed in one minute.
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Change from baseline to 8, 12, and 24 weeks
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Dyspnea assessed by the modified Medical Research Council (mMRC) scale
기간: Change from baseline to 8, 12, and 24 weeks
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Dyspnea severity measured using the mMRC scale (range 0-4, higher scores indicate worse dyspnea).
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Change from baseline to 8, 12, and 24 weeks
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COPD Assessment Test (CAT)
기간: Change from baseline to 8, 12, and 24 weeks
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Health status assessed using the CAT questionnaire (range 0-40, higher scores indicate worse health status).
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Change from baseline to 8, 12, and 24 weeks
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Short Form-36 Health Survey (SF-36)
기간: Change from baseline to 8, 12, and 24 weeks
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Health-related quality of life assessed using the SF-36 questionnaire across multiple domains.
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Change from baseline to 8, 12, and 24 weeks
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Hospital Anxiety and Depression Scale (HADS)
기간: Change from baseline to 8, 12, and 24 weeks
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Psychological status assessed using the HADS questionnaire (range 0-21 per subscale, higher scores indicate worse symptoms).
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Change from baseline to 8, 12, and 24 weeks
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Physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
기간: At 8 and 24 weeks
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Physical activity levels assessed using the IPAQ questionnaire.
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At 8 and 24 weeks
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Adherence to pulmonary rehabilitation program
기간: During the 8-week intervention period
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Adherence defined as the percentage of attended supervised sessions.
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During the 8-week intervention period
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COPD exacerbations
기간: Up to 24 weeks
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Number of COPD exacerbations during follow-up.
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Up to 24 weeks
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Emergency department visits and hospital admissions
기간: Up to 24 weeks
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Number of COPD-related emergency visits and hospital admissions.
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Up to 24 weeks
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Adverse events
기간: During the 8-week intervention and follow-up up to 24 weeks
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Incidence of adverse events, including fatigue, dyspnea, pain, dizziness, and falls.
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During the 8-week intervention and follow-up up to 24 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 1일
기본 완료 (추정된)
2028년 1월 1일
연구 완료 (추정된)
2028년 8월 1일
연구 등록 날짜
최초 제출
2026년 5월 4일
QC 기준을 충족하는 최초 제출
2026년 5월 4일
처음 게시됨 (실제)
2026년 5월 8일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 4일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Ryme Medical, Inc.아직 모집하지 않음COPD | 폐질환, 만성 폐쇄성 | COPD 환자 | COPD 급성 악화 | COPD(만성폐쇄성폐질환) | 폐 질환 항공 | COPD 악화
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Uskudar State Hospital아직 모집하지 않음폐 질환 | 폐 재활 | 원격 의료