Chronic Kidney Disease Stage 5 on DialysisNCT05241652
Inspiratory Muscle Training for Chronic Kidney Disease Patients on Hemodialysis
A study testing Inspiratory Muscle Training with an intensity of 50% MIP and Inspiratory Muscle Training with an intensity of 10% MIP in people with Chronic Kidney Disease Stage 5 on Dialysis, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Chronic Kidney Disease (CKD) is a global public health problem with an increasing prevalence and incidence, poor prognosis, and high costs. It is characterized by changes in the kidney structure and functions for more than three months. Read more about this study
- Who is it for?
- Ages 45 to 54 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5 on Dialysis
- What is being tested?
- Inspiratory Muscle Training with an intensity of 50% MIP and Inspiratory Muscle Training with an intensity of 10% MIP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 20 Feb 2022to 5 May 2022
- 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 45 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- can perform inspiratory muscle training (IMT) procedures,
- have a MIP (Maximal Inspiratory Pressure) value of less than 70% of the predicted measurement results using the micro respiratory pressure meter (RPM) tool,
- hemoglobin level greater than 8 g/dL,
- ability to understand oral and written instructions,
- cooperative and willing to participate in the research,
- able to do exercises after signing an informed consent form.
Who cannot join
- patients with obstructive lung disease, pleural effusion, cardiomegaly, heart failure, coronary heart disease, history of pneumothorax, history of thoracic or abdominal surgery in the last six months, disturbances related to eardrum damage
- have received inspiratory and expiratory muscle training in the past six months
- blood pressure >180/110 mmHg or <80/60 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strong Point of Inspiratory Muscle Training for Kidney and Immune Functions, and Quality of Life of Chronic Kidney Disease Patients on Hemodialysis
Chronic Kidney Disease (CKD) is a global public health problem with an increasing prevalence and incidence, poor prognosis, and high costs. It is characterized by changes in the kidney structure and functions for more than three months. It is grouped into several stages, including end-stage kidney disease requiring renal replacement therapy (RRT). Hemodialysis (HD) is one of the RRT options other than kidney transplantation. Regular moderate-intensity exercise may improve certain elements of the immune system and have anti-inflammatory benefits. Aerobic exercise, extremity muscle strength exercises, and inspiratory muscle training have been reported to improve kidney function and quality of life in CKD patients receiving hemodialysis three times a week. However, the effect of inspiratory muscle training on kidney and immune function, and quality of life in CKD patients receiving HD twice a week remains unclear.
Read the detailed description
Exercise causes a variety of immunological responses, including the production of interleukins. There is some evidence that exercise is correlated with a reduction in systemic inflammation. Prolonged exercise and regular exercise decrease baseline IL-6 levels as a pro-inflammatory cytokine. Inspiratory Muscle Training (IMT) exercise program can improve endothelial function and oxidative stress, both of which affect the progression of kidney disease. The IMT exercise program can induce a decrease in sympathoadrenal activation, as well as a decrease in adrenaline and noradrenaline circulation, thereby preventing endothelial and glycocalyx injury. So, the IMT can improve kidney function. Previous study showed IMT reducing urea and creatinine levels in CKD patients receiving HD thrice a week. The IMT also can improve quality of life of CKD patients receiving HD thrice a week.
Hemodialysis remains the primary RRT modality in Indonesia, and practice is strongly influenced by the socioeconomics of the region due to lack of third-party payers. Stretching resources to maximize outcome benefit is critical, and twice-weekly HD sessions are an improved and cost-effective clinical practice. Observational studies of twice-weekly HD in Taiwan and China have shown a possible benefit of the slower decline of renal function and acceptable nutritional status in recent years. However, there are limited data from performing IMT can improve kidney and immune function, and quality of life of CKD patients receiving HD twice a week.
As result of limited data, the investigators is looked forward to answer about the effect of the IMT exercise program on improving inflammatory cytokine IL-6, kidney function, and quality of life in end-stage CKD patients receiving HD twice a week.
- Being tested
- Inspiratory Muscle Training with an intensity of 50% MIP, Inspiratory Muscle Training with an intensity of 10% MIP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training with an intensity of 50% MIPOther
Patients received IMT exercise program at a 50% MIP intensity for 12 weeks
Inspiratory Muscle Training with an intensity of 10% MIPOther
Patients received IMT exercise program at a 10% MIP intensity for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Sixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 50% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks. Receives: Other: Inspiratory Muscle Training with an intensity of 50% MIP |
| Control group | Placebo comparator | Sixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 10% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks. Receives: Other: Inspiratory Muscle Training with an intensity of 10% MIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urea levels
Kidney function will measure with urea and creatinine levels. The level of urea will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The urea level in miligrams per deciliter (mg/dL).
Measured: 84 days
Creatinine levels
Kidney function will measure with urea and creatinine levels. The level of creatinine will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The creatinine level in miligrams per deciliter (mg/dL).
Measured: 84 days
IL-6 level
Immune function will measure with IL-6 level. The level of IL-6 will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The IL-6 levels in picograms per mililiter (pg/ml).
Measured: 84 days
Physical component summary (PCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. PCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
Measured: 84 days
Mental component summary (MCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. MCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
Measured: 84 days
Kidney disease component summary (KDCS)
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. KDCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start20 Feb 2022
- Primary completion26 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5 on DialysisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma Ruslina Defi, Universitas Padjadjaran
- Investigators
- Irma Ruslina Defi, M.D., Ph.D., Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241652
- Sponsor's protocol ID
- IKFR-202201.01
- Status last verified
- Mar 2023
- First submitted
- 31 Jan 2022
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
PubMed 32061315National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
PubMed 11904577Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.
PubMed 23989362Pellizzaro CO, Thome FS, Veronese FV. Effect of peripheral and respiratory muscle training on the functional capacity of hemodialysis patients. Ren Fail. 2013;35(2):189-97. doi: 10.3109/0886022X.2012.745727. Epub 2012 Nov 30.
PubMed 23199095Fassbinder TR, Winkelmann ER, Schneider J, Wendland J, Oliveira OB. Functional Capacity and Quality of Life in Patients with Chronic Kidney Disease In Pre-Dialytic Treatment and on Hemodialysis--A Cross sectional study. J Bras Nefrol. 2015 Jan-Mar;37(1):47-54. doi: 10.5935/0101-2800.20150008. English, Portuguese.
PubMed 25923750Figueiredo RR, Castro AA, Napoleone FM, Faray L, de Paula Junior AR, Osorio RA. Respiratory biofeedback accuracy in chronic renal failure patients: a method comparison. Clin Rehabil. 2012 Aug;26(8):724-32. doi: 10.1177/0269215511431088. Epub 2012 Jan 18.
PubMed 22257505Peres A, Perotto DL, Dorneles GP, Fuhro MI, Monteiro MB. Effects of intradialytic exercise on systemic cytokine in patients with chronic kidney disease. Ren Fail. 2015;37(9):1430-4. doi: 10.3109/0886022X.2015.1074473. Epub 2015 Aug 14.
PubMed 26288101Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.
PubMed 24700875Figueiredo PHS, Lima MMO, Costa HS, Martins JB, Flecha OD, Goncalves PF, Alves FL, Rodrigues VGB, Maciel EHB, Mendonca VA, Lacerda ACR, Vieira ELM, Teixeira AL, de Paula F, Balthazar CH. Effects of the inspiratory muscle training and aerobic training on respiratory and functional parameters, inflammatory biomarkers, redox status and quality of life in hemodialysis patients: A randomized clinical trial. PLoS One. 2018 Jul 26;13(7):e0200727. doi: 10.1371/journal.pone.0200727. eCollection 2018.
PubMed 30048473Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8.
PubMed 24322579Defi IR, Otafirda MV, Novitri N, Rachmi A. Feasibility of inspiratory muscle training as a rehabilitation program for chronic kidney disease patients in a developing country. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8330-8339. doi: 10.26355/eurrev_202309_33755.
PubMed 37782150
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Point of Inspiratory Muscle Training for Kidney and Immune Functions, and Quality of Life of Chronic Kidney Disease Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT05241652
- Acronym / sponsor ID
- IKFR-202201.01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 16 Feb 2022 (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 global public health problem with an increasing prevalence and incidence, poor prognosis, and high costs. It is characterized by changes in the kidney structure and functions for more than three months. It is grouped into several stages, including end-stage kidney disease requiring renal replacement therapy (RRT). Hemodialysis (HD) is one of the RRT options other than kidney transplantation. Regular moderate-intensity exercise may improve certain elements of the immune system and have anti-inflammatory benefits. Aerobic exercise, extremity muscle strength exercises, and inspiratory muscle training have been reported to improve kidney function and quality of life in CKD patients receiving hemodialysis three times a week. However, the effect of inspiratory muscle training on kidney and immune function, and quality of life in CKD patients receiving HD twice a week remains unclear.
Detailed description
Exercise causes a variety of immunological responses, including the production of interleukins. There is some evidence that exercise is correlated with a reduction in systemic inflammation. Prolonged exercise and regular exercise decrease baseline IL-6 levels as a pro-inflammatory cytokine. Inspiratory Muscle Training (IMT) exercise program can improve endothelial function and oxidative stress, both of which affect the progression of kidney disease. The IMT exercise program can induce a decrease in sympathoadrenal activation, as well as a decrease in adrenaline and noradrenaline circulation, thereby preventing endothelial and glycocalyx injury. So, the IMT can improve kidney function. Previous study showed IMT reducing urea and creatinine levels in CKD patients receiving HD thrice a week. The IMT also can improve quality of life of CKD patients receiving HD thrice a week.
Hemodialysis remains the primary RRT modality in Indonesia, and practice is strongly influenced by the socioeconomics of the region due to lack of third-party payers. Stretching resources to maximize outcome benefit is critical, and twice-weekly HD sessions are an improved and cost-effective clinical practice. Observational studies of twice-weekly HD in Taiwan and China have shown a possible benefit of the slower decline of renal function and acceptable nutritional status in recent years. However, there are limited data from performing IMT can improve kidney and immune function, and quality of life of CKD patients receiving HD twice a week.
As result of limited data, the investigators is looked forward to answer about the effect of the IMT exercise program on improving inflammatory cytokine IL-6, kidney function, and quality of life in end-stage CKD patients receiving HD twice a week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Inspiratory Muscle Training with an intensity of 50% MIPSixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 50% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks. |
| Control group | Placebo comparator | Other: Inspiratory Muscle Training with an intensity of 10% MIPSixteen patients are assigned an IMT exercise program that included inspiratory muscle strengthening exercises thrice a week at a 10% MIP intensity, five sets per time, ten breathing repetitions per set, for an estimated duration of 20 minutes each using Threshold IMT for 12 weeks. |
Who may qualify
- Ages
- 45 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- can perform inspiratory muscle training (IMT) procedures,
- have a MIP (Maximal Inspiratory Pressure) value of less than 70% of the predicted measurement results using the micro respiratory pressure meter (RPM) tool,
- hemoglobin level greater than 8 g/dL,
- ability to understand oral and written instructions,
- cooperative and willing to participate in the research,
Key exclusion criteria (3 listed)
- patients with obstructive lung disease, pleural effusion, cardiomegaly, heart failure, coronary heart disease, history of pneumothorax, history of thoracic or abdominal surgery in the last six months, disturbances related to eardrum damage
- have received inspiratory and expiratory muscle training in the past six months
- blood pressure >180/110 mmHg or <80/60 mmHg
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 |
|---|---|---|
| Inspiratory Muscle Training with an intensity of 50% MIPPatients received IMT exercise program at a 50% MIP intensity for 12 weeks | Other | Intervention group |
| Inspiratory Muscle Training with an intensity of 10% MIPPatients received IMT exercise program at a 10% MIP intensity for 12 weeks | Other | Control group |
Primary outcome
Urea levels
Time frame: 84 days
Kidney function will measure with urea and creatinine levels. The level of urea will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The urea level in miligrams per deciliter (mg/dL).
Creatinine levels
Time frame: 84 days
Kidney function will measure with urea and creatinine levels. The level of creatinine will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The creatinine level in miligrams per deciliter (mg/dL).
IL-6 level
Time frame: 84 days
Immune function will measure with IL-6 level. The level of IL-6 will examine before and 12 weeks after IMT program exercise. The examination is conducted by laboratory staff, followed by the enzymatic method. The IL-6 levels in picograms per mililiter (pg/ml).
Physical component summary (PCS)
Time frame: 84 days
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. PCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
Mental component summary (MCS)
Time frame: 84 days
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. MCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
Kidney disease component summary (KDCS)
Time frame: 84 days
Quality of life will assess using the KDQOL-SFTM v1.3 questionnaire.This questionnaire consists of a physical component summary (PCS), mental component summary (MCS), and kidney disease component summary (KDCS). We will perform interview using the KDQOL-SFTM v1.3 questionnaire before and 12 weeks after IMT program exercise. KDCS measure in Unit on Scale with range 0 to 100, higher value mean better outcome.
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 22 Mar 2023.
- Background: PubMed 32061315GBD Chronic Kidney Disease Collaboration. Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2020 Feb 29;395(10225):709-733. doi: 10.1016/S0140-6736(20)30045-3. Epub 2020 Feb 13.
- Background: PubMed 11904577National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.
- Background: PubMed 23989362Andrassy KM. Comments on 'KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease'. Kidney Int. 2013 Sep;84(3):622-3. doi: 10.1038/ki.2013.243. No abstract available.
- Background: PubMed 23199095Pellizzaro CO, Thome FS, Veronese FV. Effect of peripheral and respiratory muscle training on the functional capacity of hemodialysis patients. Ren Fail. 2013;35(2):189-97. doi: 10.3109/0886022X.2012.745727. Epub 2012 Nov 30.
- Background: PubMed 25923750Fassbinder TR, Winkelmann ER, Schneider J, Wendland J, Oliveira OB. Functional Capacity and Quality of Life in Patients with Chronic Kidney Disease In Pre-Dialytic Treatment and on Hemodialysis--A Cross sectional study. J Bras Nefrol. 2015 Jan-Mar;37(1):47-54. doi: 10.5935/0101-2800.20150008. English, Portuguese.
- Background: PubMed 22257505Figueiredo RR, Castro AA, Napoleone FM, Faray L, de Paula Junior AR, Osorio RA. Respiratory biofeedback accuracy in chronic renal failure patients: a method comparison. Clin Rehabil. 2012 Aug;26(8):724-32. doi: 10.1177/0269215511431088. Epub 2012 Jan 18.
- Background: PubMed 26288101Peres A, Perotto DL, Dorneles GP, Fuhro MI, Monteiro MB. Effects of intradialytic exercise on systemic cytokine in patients with chronic kidney disease. Ren Fail. 2015;37(9):1430-4. doi: 10.3109/0886022X.2015.1074473. Epub 2015 Aug 14.
- Background: PubMed 24700875Viana JL, Kosmadakis GC, Watson EL, Bevington A, Feehally J, Bishop NC, Smith AC. Evidence for anti-inflammatory effects of exercise in CKD. J Am Soc Nephrol. 2014 Sep;25(9):2121-30. doi: 10.1681/ASN.2013070702. Epub 2014 Apr 3.
- Background: PubMed 30048473Figueiredo PHS, Lima MMO, Costa HS, Martins JB, Flecha OD, Goncalves PF, Alves FL, Rodrigues VGB, Maciel EHB, Mendonca VA, Lacerda ACR, Vieira ELM, Teixeira AL, de Paula F, Balthazar CH. Effects of the inspiratory muscle training and aerobic training on respiratory and functional parameters, inflammatory biomarkers, redox status and quality of life in hemodialysis patients: A randomized clinical trial. PLoS One. 2018 Jul 26;13(7):e0200727. doi: 10.1371/journal.pone.0200727. eCollection 2018.
- Background: PubMed 24322579Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8.
- Derived from this study: PubMed 37782150Defi IR, Otafirda MV, Novitri N, Rachmi A. Feasibility of inspiratory muscle training as a rehabilitation program for chronic kidney disease patients in a developing country. Eur Rev Med Pharmacol Sci. 2023 Sep;27(18):8330-8339. doi: 10.26355/eurrev_202309_33755.
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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.
Irma Ruslina Defi, M.D., Ph.D. principal investigator
Universitas Padjadjaran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training with an intensity of 50% MIP and Inspiratory Muscle Training with an intensity of 10% MIP in people with Chronic Kidney Disease Stage 5 on Dialysis, run by Universitas Padjadjaran at 1 site in Indonesia.
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 6 inclusion and 3 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 22 Mar 2023. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
Urea levels (time frame: 84 days). The study lists 6 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 NCT05241652, which also lists 11 linked publications.
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 22 Mar 2023.