Chronic Kidney DiseaseCOPD TEDSNCT07803900
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
A study testing Transcutaneous electrical diaphragm stimulation (TEDS) and Inspiratory muscle training (IMT) in people with Chronic Kidney Disease and Frailty, run by Maharashtra University of Health Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Frailty
- What is being tested?
- Transcutaneous electrical diaphragm stimulation (TEDS) and Inspiratory muscle training (IMT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jan 2025to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Maharashtra Institute of Physiotherapy, Mimsr Campus, Latur
Latur, Maharashtra, 413531
About this study
Official 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 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease, Frailty
- Being tested
- Transcutaneous electrical diaphragm stimulation (TEDS), Inspiratory muscle training (IMT)
- Keywords
- Renal rehabilitation, chronic Kidney disease, functional capacity, pulmonary functions
- Medical subject headings
- Renal Insufficiency, Chronic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical diaphragm stimulation (TEDS)Device
Also called TEDS
: 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.
Inspiratory muscle training (IMT)Behavioural
Also called IMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Experimental group | Experimental | Transcutaneous electrical diaphragm stimulation (TEDS) with inspiratory muscle training (IMT) Receives: Device: Transcutaneous electrical diaphragm stimulation (TEDS); Behavioral: Inspiratory muscle training (IMT) |
| Group B - Inspiratory muscle training | Active comparator | Inspiratory muscle training (IMT) alone Receives: Behavioral: Inspiratory muscle training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after 8 weeks
Maximal inspiratory pressure
Measured by manometer
Measured: before and after 8 weeks
Pulmonary function
Measured by PFT device known as SP 10 BT. Components were FEV1, FVC
Measured: before and after 8 weeks
Six minute walk distance
Measured by six minute walk test
Measured: before and after 8 weeks
Secondary outcomes (2)
Modified research council scale (mMRC)
It is a scale has 4 components with grading according to the dysnea level
Measured: before & after 8 weeks
COPD assessment test score
health status related quality of life scales for COPD patients specifically.
Measured: Before and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start28 Jan 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Group A - Experimental group received Renal rehabilitation which includes Aerobic training, Resistance training \& Inspiratory muscle training along with multidisciplinary care
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR MINAZ NAIK, Maharashtra University of Health Sciences
- Investigators
- Dr.Minaz J Naik, MPT (Pursuing) (CVRS), Principal investigator, MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY, MIMSR CAMPUS, LATUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803900
- Sponsor's protocol ID
- MIPT,Latur
- Other IDs
- Dr,Minaz jamaluddin naik
- Acronym
- COPD TEDS
- Status last verified
- Aug 2026
- First submitted
- 31 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Because its a patient data, patient was blinded in my study. I have explain all the study details to them if they ever come to know that i have done bias with them by given conventional physiotherapy (for control group) then will feel bad so. if its necessary for trial registration to share data , then i will share.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 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
- ClinicalTrials.gov ID
- NCT07803900
- Acronym / sponsor ID
- COPD TEDS / MIPT,Latur
- Conditions
- Chronic Kidney Disease, Frailty
- Keywords
- Renal rehabilitation, chronic Kidney disease, functional capacity, pulmonary functions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group A - Experimental group received Renal rehabilitation which includes Aerobic training, Resistance training \& Inspiratory muscle training along with multidisciplinary care
| Arm | Type | Receives |
|---|---|---|
| Group A - Experimental group | Experimental | Device: Transcutaneous electrical diaphragm stimulation (TEDS), Behavioral: Inspiratory muscle training (IMT)Transcutaneous electrical diaphragm stimulation (TEDS) with inspiratory muscle training (IMT) |
| Group B - Inspiratory muscle training | Active comparator | Behavioral: Inspiratory muscle training (IMT)Inspiratory muscle training (IMT) alone |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous electrical diaphragm stimulation (TEDS)Also: TEDS: 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. | Device | Group A - Experimental group |
| Inspiratory muscle training (IMT)Also: IMTThe 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. | Behavioural | Group A - Experimental group, Group B - Inspiratory muscle training |
Primary outcome
Diaphragm excursion
Time frame: 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
Time frame: before and after 8 weeks
Measured by manometer
Pulmonary function
Time frame: before and after 8 weeks
Measured by PFT device known as SP 10 BT. Components were FEV1, FVC
Six minute walk distance
Time frame: before and after 8 weeks
Measured by six minute walk test
2 secondary outcomes
Modified research council scale (mMRC)
Time frame: before & after 8 weeks
COPD assessment test score
Time frame: Before and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication1. 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
- Evidence-based recommendations for COPD diagnosis, prevention, assessment, and management.Link provided by the sponsor.
- Provides global statistics, risk factors, symptoms, diagnosis, treatment, and prevention information for COPD.Link provided by the sponsor.
- ATS/ERS statement summarizing the principles, effectiveness, components, and advances in pulmonary rehabilitation.Link provided by the sponsor.
- Review of structural, cellular, and functional adaptations of the diaphragm in COPD and mechanisms contributing to diaphragm weakness.Link provided by the sponsor.
- Examines relationships between diaphragmatic mobility, lung function, respiratory muscle strength, dyspnea, and physical activity in COPD.Link provided by the sponsor.
- Shows that air trapping is strongly associated with reduced diaphragm mobility in COPD.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Because its a patient data, patient was blinded in my study. I have explain all the study details to them if they ever come to know that i have done bias with them by given conventional physiotherapy (for control group) then will feel bad so. if its necessary for trial registration to share data , then i will share.
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An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Minaz J Naik, MPT (Pursuing) (CVRS) principal investigator
MAHARASHTRA INSTITUTE OF PHYSIOTHERAPY, MIMSR CAMPUS, LATUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical diaphragm stimulation (TEDS) and Inspiratory muscle training (IMT) in people with Chronic Kidney Disease and Frailty, run by Maharashtra University of Health Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm excursion (time frame: Before and after 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07803900, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.