Chronic Kidney Disease
Conditions
Interventions
This is a randomized, single-blind (assessor-blinded), crossover clinical trial aimed at patients with chronic kidney disease undergoing hemodialysis, to be conducted at the Hemodialysis Center of the
0.05), and statistical tests will be applied according to the distribution of the variables, whether they are normal or non-normal. A significance level of 5% will be adopted for all statistical tests
Sponsors
Hospital Universitário Cassiano Antônio de Moraes da Universidade Federal do Espírito Santo
Hospital Universitário Cassiano Antônio de Moraes da Universidade Federal do Espírito Santo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients over 18 years of age; both sexes; undergoing hemodialysis (HD) 3 times a week at the Cassiano Antônio de Moraes University Hospital of the Federal University of Espírito Santo - HUCAM for at least 3 months; hemoglobin greater than 9 g/dL; clinical stability for at least 3 months; able to perform the proposed exercises; who agree to participate in the research and sign the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Patients with cardiovascular and respiratory symptoms and/or diseases that prevent or contraindicate the performance of the exercises; patients with amputation and/or deformity of lower limbs; patients with previous neurological sequelae; those who decide to withdraw from the research after signing the Informed Consent Form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the demographic and clinical profile of the patients, aiming to characterize the studied population and possible factors associated with the outcomes. Verified through the collection of data such as age, gender, race, occupational activity, dry weight, Body Mass Index (BMI), duration of hemodialysis, history of kidney disease, comorbidities, lifestyle habits, type of vascular access for hemodialysis, and medications in use. These descriptive and categorical data will be observed as parameters for comparative analysis between the groups;Evaluate the physiological and safety responses related to exercise during hemodialysis, aiming to identify hemodynamic and respiratory changes before and after the intervention. Verified through the measurement of blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation before and after exercise in the intervention groups, and one measurement within the first 2 hours for the control group. The values of these vital variables will be observed as parameters, as well as data from the exercise protocol (load, current intensity, number of cycles, and distance pedaled), in addition to intercurrences, complaints, and other relevant information | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of hemodialysis through the Kt/V index, aiming to find values that indicate adequate urea clearance throughout the sessions. Verified by the Kt/V calculation method, using the collection of blood samples at the beginning and at the end of each session to measure pre- and post-hemodialysis urea, as well as the recording of the total session time (t), the urea removal rate (K), and the distribution volume (V), in addition to body weight before and after each session. The values of pre- and post-hemodialysis urea, total dialysis time, initial and final patient weight, and the calculated Kt/V index will be observed as parameters, allowing verification of whether the treatment was adequate;To assess the response of vital signs before and after the interventions, it is expected to find improvement or stability of physiological parameters. This outcome will be verified through direct measurement of vital signs, using standardized clinical monitoring methods before and after the interventions. Blood pressure (mmHg), heart rate (bpm), respiratory rate (irpm), and peripheral oxygen saturation (SpO2, in %) values ??will be observed, comparing pre- and post-intervention data to identify possible changes;To evaluate the correlation between resistance exercise load and Kt/V, neuromuscular electrical stimulation (NMES) current intensity and Kt/V, as well as between vital signs and Kt/V response, expecting to find associations that indicate the influence of interventions on the effectiveness of hemodialysis. This outcome will be verified through statistical analysis of the collected data, using appropriate correlation methods. The values ??of exercise load (kg or % of 1RM), neuromuscular electrical stimulation intensity (mA), vital signs — blood pressure (mmHg), heart rate (bpm), respiratory rate (irpm), and peripheral oxygen saturation (SpO2, in %) — and Kt/V values ??will be observed, analyzing the relationship between these variables to identify possib | — |
Countries
BR
Contacts
Public ContactMarcela Moulim
Universidade do Espírito Santo
Outcome results
None listed