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| Name | Class |
|---|---|
| Leonhardt Ventures LLC | INDUSTRY |
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Chronic kidney disease (CKD) consists of kidney damage, with consequent progressive and irreversible loss of kidney function. In the early stages of the disease, a reduction in circulating levels of the α-klotho protein is already observed, which is related to worsening renal function. Therapeutic strategies that increase serum levels of α-klotho may be of great value in the treatment of CKD. Electrical stimulation contributes to the reduction of reactive oxygen species, DNA damage and improves the effectiveness rate of dialysis, suggesting a systemic effect in patients with terminal CKD. The objective of this study is to evaluate the effects of whole body electrical stimulation on renal function and physical capacity in patients with CKD not dependent on dialysis.
Patients with stage III and IV chronic kidney disease will be randomized into two groups, one group will receive whole-body electrical stimulation and the other group will be a control group (it will only be evaluated and reevaluated at the same times as the intervention group). The intervention group will perform the protocol three times a week, for eight weeks. The following assessments will be conducted pre- and post-intervention: analysis of plasma content of soluble α-Klotho and creatinine to assess renal function; measurement of interleukins and tumor necrosis factor by ELISA to analyze the inflammatory profile; beta-endorphin measurement by ELISA to assess well-being; creatine kinase dosage to assess muscle damage; 10-repetition sit-to-stand test and quadriceps muscle dynamometry to assess lower limb muscle strength; handgrip test with a dynamometer to assess upper limb strength; six-minute walk test to assess functional capacity; application of the EuroQoL-5D questionnaire for quality of life and the Pittsburgh scale to assess sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Whole-body neuromuscular electrical stimulation will be administered for three times week for eight weeks, totaling 24 sessions. |
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| Control group | No Intervention | No intervention will be carried out. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-body electrical stimulation | Other | Symmetrical biphasic current, pulse width of 400 μs, frequency of 75 Hz, contraction time of five seconds and rest time of 10 seconds. The intensity will be individually adjusted to the patient's maximum tolerance limit to reach the motor threshold and the volunteer will be instructed to achieve a score of 7 on the modified BORG scale to ensure a moderate-intense effort. The session time will be 16 minutes, resulting in a total of 64 contractions per session. The progression of overload will only occur with an increase in the intensity of all muscle groups during the sessions. Concomitantly with the electrical stimuli, the volunteer will perform exercises for the upper, lower limbs and trunk. After performing neuromuscular electrical stimulation, the patient will remain in the supine position to receive sensory stimulation throughout the body. The parameters used will be: frequency of 20 Hz and pulse width of 400 μs for 44 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in kidney function | Change in kidney function will be assessed by alpha klotho protein dosage | Baseline, after 4 and 8 weeks |
| Change in kidney function | Change in kidney function will be assessed by serum creatinine measurement | Baseline, after 4 and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory profile | Change in inflammatory profile will be assessed by measurement of interleukin 6 (IL6) | Baseline, after 4 and 8 weeks |
| Change in inflammatory profile | Change in inflammatory profile will be assessed by measurement of interleukin 10 (IL10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jociane Schardong, PhD | Contact | 55981348114 | joci_fisioufsm@yahoo.com.br | |
| Jociane Schardong, PhD | Contact | 55981348114 | jocianeschardong@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jociane Schardong, PhD | Federal University of Health Sciences of Porto Alegre | Principal Investigator |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Baseline, after 4 and 8 weeks |
| Change in inflammatory profile | Change in inflammatory profile will be assessed by measurement of tumor necrosis factor alpha (TNF-a) | Baseline, after 4 and 8 weeks |
| Change in well-being levels | Change in well-being levels will be assessed by serum beta-endorphin dosage | Baseline, after 4 and 8 weeks |
| Change in muscle damage levels | Change in muscle damage levels will be assessed by serum creatine kinase (CK) measurement | Baseline, after 4 and 8 weeks |
| Change in isometric muscle strength of the quadriceps | Change in isometric muscle strength of the quadriceps will be assessed by dynamometry | Baseline and 8 weeks |
| Change in handgrip muscle strength | Change in handgrip muscle strength will be assessed by dynamometry | Baseline and 8 weeks |
| Change in lower limb muscle strength | Change in lower limb muscle strength will be assessed using the 10-repetition sit-and-stand test (10SST) | Baseline and 8 weeks |
| Change in functional capacity | Change in functional capacity will be assessed through the distance covered in the six-minute walk test (6MWT) | Baseline and 8 weeks |
| Change in sleep quality | Change in sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).The score ranges from 0 to 21. Lower scores reflect worse sleep quality. | Baseline and 8 weeks |
| Change in quality of life | Change in quality of life will be assessed using the EuroQoL-5D (EQ-5D) questionnaire | Baseline and 8 weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |