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临床试验/NCT07803900
NCT07803900已完成不适用

Effect of Synchronized Transcutaneous Electrical Diaphragm Stimulation Using Surged Faradic Current Combined With Inspiratory Muscle Training on Diaphragm Function and Clinical Outcomes in Patients With COPDEffect of Synchronized Transcutaneous Electrical Diaphragm Stimulation Using Surged Faradic Current Combined With Inspiratory Muscle Training on Diaphragm Function and Clinical Outcomes in Patients With COPDEffect of Synchronized Transcutaneous Electrical Diaphragm Stimulation Using Surged Faradic Current Combined With Inspiratory Muscle Training on Diaphragm Function and Clinical Outcomes

Maharashtra University of Health Sciences1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年1月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Diaphragm excursion

研究概览

简要总结

Chronic kidney disease (CKD) is a progressive condition that can be associated with reduced physical capacity, muscle weakness, fatigue, respiratory impairment and frailty. These problems may affect daily activities and quality of life. Exercise-based renal rehabilitation has been increasingly considered as an important part of the management of physical problems in CKD. However, evidence regarding multimodal rehabilitation in frail patients with CKD remains limited. Therefore, the present randomized controlled trial was conducted to evaluate the effect of a 12-week multimodal renal rehabilitation programme on pulmonary function, functional capacity and fatigue in patients with CKD who were classified as frail according to the Fried Frailty Phenotype. Frailty was defined by the presence of three or more of the five Fried criteria.

A total of 54 patients were screened, and 42 eligible participants were included and randomly allocated into two equal groups, with 21 participants in each group. Group A received the multidisciplinary renal rehabilitation, which included aerobic training, resistance training, inspiratory muscle training and multidisciplinary supportive care.

Group B received conventional physiotherapy along with standard medical care. The intervention was provided 3 times a week for 12 weeks. Pulmonary function was assessed using forced expiratory volume in one second, forced vital capacity and FEV₁/FVC ratio. Functional capacity was assessed using the 6-Minute Walk Test (6MWT) and the reported VO₂max measure. Fatigue was assessed using the Daily Fatigue Impact Scale. Assessments were performed before and after the intervention.

At baseline, there were no statistically significant differences between the two groups for pulmonary function, functional capacity or fatigue measures (p>0.05), indicating that the groups were comparable before the intervention. Following the 12-week intervention, significant improvements were observed within Group A for FEV₁, FVC, FEV₁/FVC ratio, 6MWD, VO₂max and D-FIS (p<0.001 for all outcomes). Significant within-group improvements were also observed in Group B for the measured pulmonary function, functional capacity and fatigue outcomes (p<0.001).

The between-group analysis showed statistically significant differences in favour of Group A for FEV₁, FVC, 6MWD, VO₂max and D-FIS (p<0.001). However, the between-group difference in FEV₁/FVC ratio was not statistically significant (p>0.05).

Thus, although both groups demonstrated improvement over time, the multimodal renal rehabilitation group demonstrated significantly greater improvement in most of the measured outcomes compared with conventional physiotherapy along with standard medical care.

The findings suggested that the multidisciplinary renal rehabilitation was effective in

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improving pulmonary function, functional capacity and fatigue in CKD patients with frailty over the 12-week intervention period. The improvement in fatigue was particularly evident from the significant reduction in D-FIS scores in Group A compared with Group B (between-group p<0.001). Similarly, the significant between group improvement in 6MWD and VO₂max (p<0.001) indicated better functional exercise capacity following the rehabilitation programme. The findings were consistent with previous research showing beneficial effects of exercise-based interventions on physical function and fatigue in patients with CKD. However, the study evaluated a combined rehabilitation programme, and therefore the individual contribution of aerobic training, resistance training, inspiratory muscle training and multidisciplinary support could not be determined separately. Other limitations included the relatively small sample size, and limited follow-up period.

Therefore, larger randomized controlled trials with longer follow-up are required to confirm the findings and determine whether the observed improvements are observed over time. Overall, the study concluded that a 12-week multidisciplinary renal rehabilitation may be a useful approach for improving pulmonary function, functional capacity and fatigue in CKD patients with frailty.

详细描述

Ethical clearance was obtained from the Institutional Ethics Committee before commencement of the study. A total of 54 CKD patients were screened, of whom 42 participants fulfilling the eligibility criteria were included in the study. Written informed consent was obtained from all participants. Baseline assessment was performed using Pulmonary Function Tests (FEV₁, FVC and FEV₁/FVC ratio), 6-Minute Walk Test (6MWD, VO₂max) and Daily Fatigue Impact Scale (D-FIS).

The 42 participants were randomly allocated into two equal groups of 21 participants each.

Group A - Renal Rehabilitation :

Participants received a structured renal rehabilitation programme consisting of aerobic training, resistance training and inspiratory muscle training for 3 days per week for 12 weeks.

Each session started with 5-10 minutes of warm-up, followed by the training programme and ended with 5-10 minutes of cool-down.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Participants were medically diagnosed with moderate COPD (GOLD stage II-III) and were 40-70 years of age. Eligible participants included both males and females who were clinically stable, had the ability to understand and follow study instructions, and had a maximal inspiratory pressure (MIP) below 60 cmH₂O in males or below 50 cmH₂O in females

排除标准

  • Patients were excluded if they had an acute COPD exacerbation, a cardiac pacemaker, unstable cardiovascular disease such as recent myocardial infarction or unstable angina, uncontrolled hypertension, or recent fractures.

研究组 & 干预措施

Group A - Experimental group

Experimental

Transcutaneous electrical diaphragm stimulation (TEDS) with inspiratory muscle training (IMT)

干预措施: Transcutaneous electrical diaphragm stimulation (TEDS) (Device)

Group A - Experimental group

Experimental

Transcutaneous electrical diaphragm stimulation (TEDS) with inspiratory muscle training (IMT)

干预措施: Inspiratory muscle training (IMT) (Behavioral)

Group B - Inspiratory muscle training

Active Comparator

Inspiratory muscle training (IMT) alone

干预措施: Inspiratory muscle training (IMT) (Behavioral)

结局指标

主要结局

Diaphragm excursion

时间窗: Before and after 8 weeks

Diaphragm excursion was assessed using chest radiographs obtained at maximum inspiration and maximum expiration. The highest point of each hemidiaphragm during maximum expiration was identified, and a longitudinal line was drawn to the corresponding point during maximum inspiration. The distance between the inspiratory and expiratory positions was measured as diaphragm excursion. A radiographic ruler was used for correction of image magnification. The same measurement procedure was applied at baseline and after the intervention. Measurements were performed by a single assessor using a radiographic scale to account for image magnification.

Maximal inspiratory pressure

时间窗: before and after 8 weeks

Measured by manometer

Pulmonary function

时间窗: before and after 8 weeks

Measured by PFT device known as SP 10 BT. Components were FEV1, FVC

Six minute walk distance

时间窗: before and after 8 weeks

Measured by six minute walk test

次要结局

  • Modified research council scale (mMRC)(before & after 8 weeks)
  • COPD assessment test score(Before and after 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

DR MINAZ NAIK

Effect of Synchronized Transcutaneous Electrical Diaphragm Stimulation Using Surged Faradic Current Combined with Inspiratory Muscle Training on Diaphragm Function and Clinical Outcomes in Patients with COPD

Maharashtra University of Health Sciences

研究点 (1)

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