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Isoinertial Training in Patients With COPD (ISTrainingCOPD)

2026년 5월 26일 업데이트: David Murcia-Lesmes, PhD, Universidad Manuela Beltrán

Effect of Isoinertial Training on Muscle Strength and Functional Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Randomized Controlled Clinical Trial

Isoinertial training is emerging as a potentially effective strategy to improve strength and functionality in older people diagnosed with chronic obstructive pulmonary disease (COPD), due to its influence on muscle mass and neuromuscular efficiency. COPD is characterized by systemic alterations, including peripheral muscle dysfunction; which contributes to patient functional limitation, and reduces patients' quality of life. Isoinertial training may improve the physiological response to effort, and also promote functional performance in this population. Hence, the aim of this study is to evaluate the effect of an isoinertial training program on muscle strength and functional capacity in patients with COPD during an 8-week intervention.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

To assess the effects of an isoinertial training programme on muscle strength and functional capacity in older people diagnosed with chronic obstructive pulmonary disease (COPD), in a randomized controlled clinical trial. Thirty participants diagnosed with moderate to severe COPD, over 50 years (50% men, 50% women), will be included to analyze possible differences in the training response compared to the control group. Participants will sign the informed consent and randomly assign to the intervention or control group. The intervention consists in a supervised isoinertial training program, while the control group will continue with the usual pulmonary rehabilitation program. Patients will be subjected to an initial assessment that include the application of tests of functional capacity, muscle strength, as well as clinical parameters and sociodemographic characteristics. The intervention will last 8 weeks, with a frequency of 2 to 3 sessions per week. The training program will include exercises aimed at strengthening the upper and lower limbs, using a isoinertial device with controlled load progression.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 콜롬비아
    • Bogotá, DC
      • Bogotá, Bogotá, DC, 콜롬비아, 110231
        • 모병
        • Universidad Manuela Beltrán
        • 수석 연구원:
          • David Murcia-Lesmes, PhD
        • 부수사관:
          • Edwin Fernando Gutiérrez-Reyes, MSc
    • Ibagué
      • Ibague, Ibagué, 콜롬비아, 730006
        • 모병
        • Pulsar Unidad de Neumologia y Rehabilitación Pulmonar

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • People between 50 - 80 years of age diagnosed with moderate or severe COPD
  • No acute exacerbations in the last 4 weeks
  • Sufficient functional capacity to exercise
  • Signed informed consent

Exclusion Criteria:

  • Presence of neurological, musculoskeletal, or cardiovascular diseases that significantly limit exercise performance or compromise participant safety; including uncontrolled hypertension, recent myocardial infarction, unstable angina, severe osteoarthritis, stroke sequelae, or Parkinson's disease.
  • Contraindications to exercise participation according to medical evaluation.
  • Recent surgeries in the past 3 months
  • Simultaneous participation in other exercise programs
  • Cognitive disorders

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
실험적: Supervised isoinertial training
Participants will perform a supervised isoinertial training program during 8 weeks of follow-up
장치: Isoinertial training

Supervised isoinertial training:

  • Participants will perform a supervised isoinertial training program during 8 weeks of follow-up
  • The intervention will have a frequency of 2 to 3 weekly sessions
  • The program will include exercises aimed at strengthening the upper and lower limbs using a isoinertial device
  • The training load will be progressive to each participant and adjusted according to the individual response.
  • The program will be carried out in combination with usual pulmonary rehabilitation care.
활성 비교기: Traditional rehabilitation

Participants involved in the usual pulmonary rehabilitation program

  • The usual recommendations for physical activity and clinical follow-up will be maintained
  • No isoinertial training
다른: Traditional rehabilitation (control group)

Traditional treatment (control group)

  • Participants involved in the usual pulmonary rehabilitation program during 8 weeks with a frequency of 2-3 sessions per week.
  • This program includes low- to moderate-intensity aerobic exercise, joint mobility activities and general strengthening exercises using conventional resources according to the clinic's rehabilitation protocol.
  • No isoinertial training

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in upper limb muscle strength using the Hand Grip Test (HGT)
기간: Baseline and 8-week follow-up
Manual grip strength will be evaluated by dynamometry, as an indicator of peripheral muscle strength in patients with COPD.
Baseline and 8-week follow-up
Change in functional capacity by 6-minute walk test (6MWT)
기간: Baseline and 8-week follow-up
The distance covered for 6 minutes will be evaluated as an indicator of exercise tolerance and functional capacity.
Baseline and 8-week follow-up
Lower limb functional performance
기간: Baseline and 8-week follow-up
The number of repetitions performed in 30 seconds will be recorded as an indicator of functional strength-endurance in the lower limbs
Baseline and 8-week follow-up
Change in functional mobility using the Timed Up and Go Test (TUG)
기간: Baseline and 8-week follow-up
The time needed to get up from a chair, walk, turn and sit down again will be measured, as an indicator of mobility and functional risk.
Baseline and 8-week follow-up
Change in muscle quality index (MQI)
기간: Baseline and 8-week follow-up
Muscle quality will be estimated using the MQI, which evaluates the muscle power of the lower limbs considering leg length, body mass, gravitational acceleration and time required to complete 10 sit-to-stand repetitions
Baseline and 8-week follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
Change in functional performance using 5 Times Sit-to-Stand Test (5STS)
기간: Baseline and 8-week follow-up
Time required to perform 5 repetitions of standing and sitting will be measured, as a complementary indicator of lower limb function
Baseline and 8-week follow-up
Change in health-related quality of life through The Saint George's Respiratory Questionnaire (SGRQ)
기간: Baseline and 8-week follow-up
The SGRQ will be applied to assess the symptoms, activity and impact of the respiratory disease. This score ranges from 0 to 100 points, a higher score indicates poor health.
Baseline and 8-week follow-up
Changes in Body Mass Index (BMI)
기간: Baseline and 8-week follow-up
Body mass index (BMI) will be assessed to characterize participants' anthropometric status. BMI will be calculated as body weight divided by height squared and expressed in kilograms per square meter (kg/m^2).
Baseline and 8-week follow-up
Changes in heart rate
기간: Baseline and 8-week follow-up
Heart rate (bpm) will be measured using an automatic monitor
Baseline and 8-week follow-up
Changes in blood pressure
기간: Baseline and 8-week follow-up
Diastolic and systolic blood pressure (mmHg) will be measured using a blood pressure monitor
Baseline and 8-week follow-up
Changes in oxygen saturation (SpO2)
기간: Baseline and 8 week follow-up
Oxygen saturation (Percentage, %) will be measured using an oximeter.
Baseline and 8 week follow-up

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universidad Manuela Beltrán

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)

2026년 5월 7일

기본 완료 (추정된)

2026년 7월 25일

연구 완료 (추정된)

2026년 7월 27일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 19일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 26일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • DCTAFD24 23

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Data availability to external researchers is restricted to related project proposals upon request to the PI.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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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