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

NCT07803900 | Completed

• 2 other identifiers: MIPT,LaturDr,Minaz jamaluddin naik
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease; Frailty

Keywords

Renal rehabilitation, chronic Kidney disease, functional capacity, pulmonary functions

Outcome Measures

Primary Outcomes (4)

• Diaphragm excursion

  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

  Measured by manometer

  before and after 8 weeks

• Pulmonary function

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

  before and after 8 weeks

• Six minute walk distance

  Measured by six minute walk test

  before and after 8 weeks

Secondary Outcomes (2)

• Modified research council scale (mMRC)

  before & after 8 weeks

• COPD assessment test score

  Before and after 8 weeks

Study Arms (2)

Group A - Experimental group

EXPERIMENTAL

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

Device: Transcutaneous electrical diaphragm stimulation (TEDS); Behavioral: Inspiratory muscle training (IMT)

Group B - Inspiratory muscle training

ACTIVE COMPARATOR

Inspiratory muscle training (IMT) alone

Behavioral: Inspiratory muscle training (IMT)

Interventions

Inspiratory muscle training (IMT) BEHAVIORAL

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.

Also known as: IMT

Group A - Experimental group; Group B - Inspiratory muscle training

Transcutaneous electrical diaphragm stimulation (TEDS) DEVICE

: 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.

Also known as: TEDS

Group A - Experimental group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maharashtra University of Health Sciences: lead

Study Sites (1)

Maharashtra Institute of Physiotherapy, Mimsr Campus, Latur

Latur, Maharashtra, 413531, India

Location

Related Publications (1)

• 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

  RESULT

Related Links

• 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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Frailty

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr.Minaz J Naik, MPT (Pursuing) (CVRS)

  MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY, MIMSR CAMPUS, LATUR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: Group A - Experimental group received Renal rehabilitation which includes Aerobic training, Resistance training \& Inspiratory muscle training along with multidisciplinary care

Study Record Dates

• First Submitted: August 31, 2026
• First Posted: September 4, 2026
• Study Start: January 28, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

IN (1)