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 (COPD TEDS)
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
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
41
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.
調査の概要
状態
詳細な説明
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.
• Aerobic Training: Aerobic exercise included cycle ergometer. Exercise intensity was maintained at approximately 40-60% of maximum heart rate and RPE 11-13. Aerobic exercise was initially performed for approximately 20-30 minutes and progressively increased by 5 minutes every 2 weeks according to tolerance, up to a maximum of 60 minutes.
• Resistance Training: Exercises were performed for major upper- and lower-limb muscle groups using free weights. The initial resistance was approximately 50% of 10RM, with 10 repetitions per set. Exercises included functional lower-limb and upper-limb strengthening such as sit-to-stand, knee extension, heel raises, biceps curls and shoulder exercises. Rest intervals of approximately 1-2 minutes were provided between exercises/sets. Resistance was progressively increased according to the participant's tolerance and ability to complete the prescribed repetitions with proper technique.
• Inspiratory Muscle Training: IMT was performed using a Threshold Inspiratory Muscle Trainer. Participants performed 5 sets of 10 breaths per session, with 1minute rest between sets. Training intensity was progressively increased according to MIP: 50% MIP during weeks 1-3, 60% during weeks 4-6, 70% during weeks 7-9 and 80% during weeks 10-12, as tolerated.
During all sessions, exercise intensity was individualized according to vitals stability, patient tolerance and clinical condition. Heart rate, blood pressure, SpO₂, fatigue and symptoms were monitored throughout the intervention.
Group B - Conventional Physiotherapy with standard medical care :
Group B received conventional physiotherapy with standard medical care, consisting of general upper- and lower-limb mobility exercises, diaphragmatic breathing exercises, stretching and active range-of-motion exercises for 30-40 minutes per session, 3 days per week for 12 weeks.
Multidisciplinary Care
- Nephrologist: Conducted the initial CKD assessment, staging, medication review, blood pressure assessment and medical clearance before starting rehabilitation (Week 1). Medical review was repeated at Week 4, Week 8 and Week 12, or earlier if clinically indicated, to assess medical problems and exercise safety.
- Renal dietitian: Provided individualized renal dietary counselling at Week 1, including appropriate protein and energy intake, sodium, potassium, phosphorus and fluid management according to CKD stage and laboratory findings. Dietary follow-up was conducted at Week 4, Week 8 and Week 12 to reinforce dietary adherence and modify recommendations when required.
- Nurse: Monitored vital signs and exercise-related symptoms during every rehabilitation session throughout Weeks 1-12. The nurse also provided patient education, reinforced adherence to the exercise programme and coordinated with the rehabilitation team. Additional monitoring was performed whenever clinically required.
At the end of 12 weeks, all participants were reassessed using the same outcome measures. Pre- and post-intervention data were recorded and statistically analyzed to determine the effect of renal rehabilitation on pulmonary functions, functional capacity and fatigue.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Maharashtra
-
Latur、Maharashtra、インド、413531
- Maharashtra Institute of Physiotherapy, Mimsr Campus, Latur
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group A - Experimental group
Transcutaneous electrical diaphragm stimulation (TEDS) with inspiratory muscle training (IMT)
|
: TEDS was delivered bilaterally using two channels and four surface electrodes.
The frequency was fixed at 30 Hz, pulse duration at 400 µs, rise time at approximately 1 s, ON time at 1 s, and OFF time at 3 s.
Current amplitude was individually adjusted according to participant tolerance and increased to achieve a visible or palpable diaphragmatic contraction.
Electrode placement was standardized bilaterally at the 7th-8th intercostal spaces along the mid-axillary lines.
Stimulation was synchronized manually with the inspiratory phase.The stimulation was synchronized with the inspiratory phase of breathing.
The patient was instructed to start inspiration when the electrical stimulation started and to breathe out during the relaxation phase.
The therapist monitored the patient's breathing and stimulation timing throughout the session to maintain synchronization.
他の名前：
The IMT protocol used a Threshold IMT device. Training was initiated at 30% of MIP and progressed to 60% of MIP. Each session lasted 15-20 minutes and was performed three times per week for 8 weeks. IMT: 5 sets × 10 breaths, with 1-minute rest between sets, 3 sessions/week for 8 weeks.
他の名前：
|
|
アクティブコンパレータ：Group B - Inspiratory muscle training
Inspiratory muscle training (IMT) alone
|
The IMT protocol used a Threshold IMT device. Training was initiated at 30% of MIP and progressed to 60% of MIP. Each session lasted 15-20 minutes and was performed three times per week for 8 weeks. IMT: 5 sets × 10 breaths, with 1-minute rest between sets, 3 sessions/week for 8 weeks.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Diaphragm excursion
時間枠：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.
|
Before and after 8 weeks
|
|
Maximal inspiratory pressure
時間枠：before and after 8 weeks
|
Measured by manometer
|
before and after 8 weeks
|
|
Pulmonary function
時間枠：before and after 8 weeks
|
Measured by PFT device known as SP 10 BT.
Components were FEV1, FVC
|
before and after 8 weeks
|
|
Six minute walk distance
時間枠：before and after 8 weeks
|
Measured by six minute walk test
|
before and after 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Modified research council scale (mMRC)
時間枠：before & after 8 weeks
|
It is a scale has 4 components with grading according to the dysnea level
|
before & after 8 weeks
|
|
COPD assessment test score
時間枠：Before and after 8 weeks
|
health status related quality of life scales for COPD patients specifically.
|
Before and after 8 weeks
|
協力者と研究者
捜査官
- 主任研究者：Dr.Minaz J Naik, MPT (Pursuing) (CVRS)、Maharashtra Institute of Physiotherapy, Mimsr Campus, Latur
出版物と役立つリンク
一般刊行物
- 1. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2025 report. Fontana (WI): GOLD; 2025. 2. World Health Organization. Chronic obstructive pulmonary disease (COPD). Geneva: World Health Organization; 2024. 3. Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013;188(8):e13-e64. 4. Ottenheijm CAC, Heunks LMA, Dekhuijzen PNR. Diaphragm adaptations in patients with chronic obstructive pulmonary disease. Respir Res. 2008;9:12. 5. Rocha FR, Brüggemann AK, Francisco DS, Medeiros CS, Rosal D, et al. Diaphragmatic mobility: relationship with lung function, respiratory muscle strength, dyspnea and physical activity in daily life in patients with COPD. J Bras Pneumol. 2017;43(1):32-37. 6. Yamaguti WP, Paulin E, Shibao S, Chammas MC, Salge JM, et al. Air trapping: the major factor limiting diaphragm mobility in chronic obstructive pulmonary disease patients. Respirology. 2008;13(1):138-144. 7. American Thoracic Society/European Respiratory Society. ATS/ERS statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002;166(4):518-624. 8. Hill K, Jenkins SC, Philippe DL, Cecins N, Shepherd KL, et al. High-intensity inspiratory muscle training in COPD. Eur Respir J. 2006;27(6):1119-1128. 9. Ammous O, Feki W, Lotfi T, Khamis AM, Gosselink R, et al. Inspiratory muscle training, with or without concomitant pulmonary rehabilitation, for chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2023;1(1):CD013778. 10. Sbruzzi G, Callegari G, Marques CF, Chiappa GR. Effects of electrical stimulation on inspiratory muscles in patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis. Clin Rehabil. 2021;35(10):1363-1373. 11. Zhao Z, Sun W, Zhao
便利なリンク
- Evidence-based recommendations for COPD diagnosis, prevention, assessment, and management.
- Provides global statistics, risk factors, symptoms, diagnosis, treatment, and prevention information for COPD.
- ATS/ERS statement summarizing the principles, effectiveness, components, and advances in pulmonary rehabilitation.
- Review of structural, cellular, and functional adaptations of the diaphragm in COPD and mechanisms contributing to diaphragm weakness.
- Examines relationships between diaphragmatic mobility, lung function, respiratory muscle strength, dyspnea, and physical activity in COPD.
- Shows that air trapping is strongly associated with reduced diaphragm mobility in COPD.
- Provides standardized methods and recommendations for assessing respiratory muscle strength and function.
- Randomized trial showing that high-intensity inspiratory muscle training can improve inspiratory muscle strength, exercise capacity, dyspnea, and fatigue in COPD.
- Cochrane systematic review evaluating inspiratory muscle training alone and combined with pulmonary rehabilitation in COPD.
- Randomized pilot study comparing stimulation of both inspiratory/expiratory muscles with diaphragm-only stimulation in severe COPD; the combined approach improved 6-minute walking distance.
- Systematic review/meta-analysis suggesting neuromuscular electrical stimulation may improve exercise capacity, physical activity, quality of life, and dyspnea in moderate-to-severe COPD.
- Biomedical instrumentation textbook covering principles and applications of medical measurement and instrumentation.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MIPT,Latur
- Dr,Minaz jamaluddin naik (レジストリ識別子：Dr. Minaz naik)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。