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국문

목적: 호흡근 훈련은 노인들에게 다양한 임상적 이점이 있지만 낮은 훈련 순응도는 여전히 해결하기 어려운 문제이다. 본 연구의 목적은 새로운 장치의 안전성 및 효과를 확인하고, 임상 효과 및 훈련 순응도 향상을 위한 최적의 훈련 프로토콜을 찾는 것이다. 

대상 및 방법: 4개의 군, 다기관, 전향적, 무작위, 병렬, 비열등성 임상시험은 80명의 지역사회 거주 노인 남성 (평균연령 = 72.9세)을 센터 기반 그룹 (combined IMT/PEP 또는 Threshold IMT, 16 회의 지도 훈련 포함) 또는 가정 기반 그룹 (combined IMT/PEP 또는 Threshold IMT, 2 회의 지도 훈련 포함)에 무작위 배정하였다. 모든 대상자는 호흡근훈련을 하루 2회씩 8주간 시행하였다. 평가는 등록 초기와 8주간의 훈련이 끝난 직후 실시하였다. 1차 평가지표는 최대 흡기압과 최대 호기압이고, 이차 변수로는 폐기능, 최대기침유량, 횡격막 두께, 최고산소섭취량, 국제신체활동설문, 흉쇄유돌근에서의 근활성도, 생체전기임피던스 분석을 통한 근육량과 위상각이 있다. 또한 각 프로토콜 별로 훈련 순응도를 비교하였다. 

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Purpose: Respiratory muscle training (RMT) has various clinical benefits in older adults, but low adherence rate of training remains a difficult issue to resolve. The aim of this present study was to confirm the safety and efficacy of this new device and to determine the best protocol for improving training adherence rate and effect.

Patients and methods: This four-arm, multicenter, prospective, randomized, parallel, non-inferiority trial randomized 80 active community-dwelling elderly males (mean age = 72.9 years) to center-based groups (combined IMT/PEP or Threshold IMT, 16 supervised sessions) or home-based groups (combined IMT/PEP or Threshold IMT, 2 supervised sessions). Participants in all groups performed RMT twice a day for eight weeks. Assessment were performed at baseline and post-training. The primary outcomes were maximum inspiratory pressure and maximal expiratory pressure, and the secondary outcomes were pulmonary function, peak cough flow, diaphragm thickness, VO2 peak, the International Physical Activity Questionnaire score, electromyography activities of the sternocleidomastoid muscle, and skeletal muscle mass and phase angle by bioimpedance analysis. In addition, adherence rates to each protocol were also compared.

국문

4개의 군, 다기관, 전향적, 무작위, 병렬, 비열등성 임상시험은 80명의 지역사회 거주 노인 남성 (평균연령 = 72.9세)을 센터 기반 그룹 (combined IMT/PEP 또는 Threshold IMT, 16 회의 지도 훈련 포함) 또는 가정 기반 그룹 (combined IMT/PEP 또는 Threshold IMT, 2 회의 지도 훈련 포함)에 무작위 배정하였다. 모든 대상자는 호흡근훈련을 하루 2회씩 8주간 시행하였다. 평가는 등록 초기와 8주간의 훈련이 끝난 직후 실시하였다. 1차 평가지표는 최대 흡기압과 최대 호기압이고, 이차 변수로는 폐기능, 최대기침유량, 횡격막 두께, 최고산소섭취량, 국제신체활동설문, 흉쇄유돌근에서의 근활성도, 생체전기임피던스 분석을 통한 근육량과 위상각이 있다. 또한 각 프로토콜 별로 훈련 순응도를 비교하였다. 

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This four-arm, multicenter, prospective, randomized, parallel, non-inferiority trial randomized 80 active community-dwelling elderly males  to center-based groups (combined IMT/PEP or Threshold IMT, 16 supervised sessions) or home-based groups (combined IMT/PEP or Threshold IMT, 2 supervised sessions). Participants in all groups performed RMT twice a day for eight weeks. Assessment were performed at baseline and post-training. The primary outcomes were maximum inspiratory pressure and maximal expiratory pressure, and the secondary outcomes were pulmonary function, peak cough flow, diaphragm thickness, VO2 peak, the International Physical Activity Questionnaire score, electromyography activities of the sternocleidomastoid muscle, and skeletal muscle mass and phase angle by bioimpedance analysis. In addition, adherence rates to each protocol were also compared.

The participants were randomly assigned in a 1:1:1:1 manner into the following groups, depending on the device allocated and the training site: IMT/PEP in the rehabilitation center (Group N-C), Threshold IMT in the rehabilitation center (Group I-C), IMT/PEP at home (Group N-H), and Threshold IMT at home (Group I-H). For all participants, several practice tests were performed to correct possible training and learning effects, before the tests were conducted. All evaluations and training were conducted by different blinded researchers. 

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Groups N-C and I-C visited the rehabilitation center twice a week to undergo supervised training for eight weeks. They also performed self-training with the individualized intensity twice a day at home for eight weeks. For all participants, one self-training session was omitted on the day of supervised training. 
The inspiratory threshold for each device was set to 40% of the initial MIP of the each participant, and the maximum threshold of the device was 40 cmH2O. Considering that the average maximal expiratory pressure (MEP) is above 100 cmH2O for those over sixty years of age, the expiratory threshold was set to 20 cmH2O, the maximum load of the device, for groups using the combined IMT/PEP (Groups N-C and N-H). All participants were instructed to inspire, from residual volume, at a constant intensity and strength to exceed the threshold pressure. When they reached vital capacity, they held their breath for several seconds and then exhaled at a constant intensity for as long as possible. Each set of RMT consisted of ten deep and forceful breaths against the threshold pressure of the device. Twice a day, ten sets were performed with two minutes of rest after each set. During the first training, two sets of training were practiced at half the target threshold to allow the patient to adapt to the devices. All participants kept a home exercise diary, which was used to check the training adherence, and all training in the rehabilitation center was conducted under the supervision of an experienced physiotherapist.

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Same as protocol of the Group N-C

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Groups N-H and I-H performed the same RMT twice a day at home for eight weeks, with only two supervised training sessions. For all participants, one self-training session was omitted on the day of supervised training. A telephone interview was conducted four weeks after enrollment to confirm whether there were any problems with the training or device for the participants in Groups N-H and I-H.
The inspiratory threshold for each device was set to 40% of the initial MIP of the each participant, and the maximum threshold of the device was 40 cmH2O. Considering that the average maximal expiratory pressure (MEP) is above 100 cmH2O for those over sixty years of age, the expiratory threshold was set to 20 cmH2O, the maximum load of the device, for groups using the combined IMT/PEP (Groups N-C and N-H). All participants were instructed to inspire, from residual volume, at a constant intensity and strength to exceed the threshold pressure. When they reached vital capacity, they held their breath for several seconds and then exhaled at a constant intensity for as long as possible. Each set of RMT consisted of ten deep and forceful breaths against the threshold pressure of the device. Twice a day, ten sets were performed with two minutes of rest after each set. During the first training, two sets of training were practiced at half the target threshold to allow the patient to adapt to the devices. All participants kept a home exercise diary, which was used to check the training adherence, and all training in the rehabilitation center was conducted under the supervision of an experienced physiotherapist.

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Same as protocol of the Group N-H

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Community-dwelling men over 60 years of age 

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maximum inspiratory pressure (MIP)

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Before the training,   8 weeks after each training

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maximal expiratory pressure (MEP)

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Peak Cough Flow

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Before the training,   8 weeks after each training

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Diaphragm Thickness  

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Before the training,   8 weeks after each training

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Aerobic capacity though Chester step test

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Before the training,   8 weeks after each training

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Phase angles and skeletal muscle mass 

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Before the training,   8 weeks after each training

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Muscle activity of the left Sternoclavicularmastoid muscle

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Before the training,   8 weeks after each training

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forced vital capacity (FVC) and forced expiratory volume in the first second (FEV1)

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Before the training,   8 weeks after each training