Chronic kidney disease, end-stage renal disease, hemodialysis
Conditions
Interventions
Sample size were calculated based on the functional capacity assessed by previous studies using a power of 0.95, with a 1.19 effect size and a 0.05 alpha. Thus 40 patients will be recruited, 20 for ea
Other
F04.754.137.506.662
Sponsors
Universidade Federal de Sergipe
Clinica de Nefrologia de Sergipe
Eligibility
Inclusion criteria
Inclusion criteria: Volunteer both genders; older than 18 years; sedentary; performing hemodialysis three times per week for at least three months; stable clinical condition in terms of no hospitalizations or cardiovascular events within the 3 months prior to screening; Systolic blood pressure (SBP) <200 mmHg and diastolic blood pressure (DBP) <110 mmHg at baseline.
Exclusion criteria
Exclusion criteria: Volunteers with diagnoses of pulmonary, neurological or psychiatric disorders; presence of unstable angina; recent myocardial infarction less than 6 months; symptomatic left ventricular fibrillation; decompensated heart failure; visual and / or hearing disorders; musculoskeletal limitations; hemiplegia or hemiparesis that compromise the ability to perform the exercises; hospitalization during the study period; neoplasms in current chemotherapy and / or radiotherapy; diagnosis of infection by the human immunodeficiency virus; scheduled kidney transplant or already carried out; volunteers who are not available to participate in all stages of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sample size estimates were calculated between the intervention and control groups based on the functional capacity assessed by previous studies using a power of 0.95, with a 1.19 effect size and a 0.05 alpha. The first functional variable was the gait speed test which followed the classification proposed by SCHMID et al. (2007) in which the individual was considered with full ambulation capacity in the community> 0.8 m/s. Changes between 0.1 and 0.2 m/s seems to be clinically important according to previous studies.;The next functional test was Time Up and Go (TUG). Following the recommendations of Roshanravan et al. (2013) the individual was considered fast if accomplished the performance with a time 12 sec; Every 1 second longer was associated with an 8% increase in risk of death (95% CI, 1%, 14%).;Questionnaire Duke Activity Status Index (DASI) was applied to evaluate the perception of the individual as their functionality. There is no cut-off point for the analysis of this questionnaire were therefore considered their total value and the average of each group making a comparison using independent t test for the presence of statistical differences. Each question answered positively sum equivalent points in METs to the activities that he can develop. The higher the score, the greater the functional capacity. This score ranges from zero to 58.2.;To evaluate the quality of life, we used the questionnaire Kidney Disease Quality Of Life-Short Form (KDQOL-SFTM 1.3) according to the recommendations of the Working Group KDQOL. The scores of questions were generated by the standard tool by the group and available at Excel. The means will be compared between groups for verification of statistical differences within each domain. A 5-point cutoff point intra-group for each domain was used to assess the clinical relevance.;To assess depression we used the screening scale for depressive symptoms - Center for Epidemiological -Depression Scale (CES-D). Originally, the CES-D sca | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of Blood Pressure: All monitoring will be based on V Guideline for Ambulatory Blood Pressure (2011). The results will be assessed by the mean and compared between groups. ;Analysis of Heart Rate Variability (HRV): patients will be instrumented with a heart rate monitor (Polar RS800CX) and a pickup belt is positioned in the distal third of the sternum, allowing the recording of heart rate (HR) .The results will be evaluated by the average and comparison between groups. ;Adverse effects will be investigated descriptively throughout the study in both groups.;Hospitalization and mortality from various causes within 12 weeks of follow-up of the individual. | — |
Countries
Brazil
Contacts
Public ContactLuana Maynard
Universidade Tiradentes
Outcome results
None listed