Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06055283 |
| Other study ID # |
ECRC/CKD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2023 |
| Est. completion date |
December 31, 2026 |
Study information
| Verified date |
September 2023 |
| Source |
University of the State of Santa Catarina |
| Contact |
Jéssica Canizelli Gonçalez, Ms |
| Phone |
47996087774 |
| Email |
jessicacgoncalez[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical trial is to evaluate the effects of intradialytic aerobic exercise
on muscle capacity, functionality and motivation of patients with chronic kidney disease
undergoing hemodialysis.
The main question it aims to answer are:
• Is intradialytic aerobic exercise at moderate intensity effective in improving peripheral
muscle function, functional status and motivation in patients with chronic kidney disease?
Description:
The progressive and irreversible advance of chronic kidney disease generates the systemic
involvement of the organism and, consequently, the impairment of functionality and quality of
life. Hemodialysis therapy is a strategy to increase survival and its long implementation
time appears as a space for physiotherapeutic interventions in delaying functional impairment
in these individuals. The objective will be to evaluate the effects of intradialytic aerobic
exercise on muscle capacity, functionality and motivation of patients with chronic kidney
disease undergoing hemodialysis. Patients with chronic kidney disease who undergo
hemodialysis at TR São José - Clínica de hemodialysis LTDA (São José/SC) will be evaluated.
Patients will be randomized, via a convenience sample, into two groups: intradialytic aerobic
exercise group and control group. Interventions will take place within the first two hours of
hemodialysis, using a portable cycle ergometer. Intensity will be controlled by heart rate
and BORG Perceived Exertion Index. The training, for both groups, will be three times a week,
for a period of three months. The aerobic exercise intensity will be moderate, in the
percentage of maximum heart rate from 55 to 74% and BORG 4 to 6. A portable cycle ergometer
will be used. The evaluations will be in the baseline period, after each complete month and
after six months of the end. There will be three days of assessments at the hemodialysis
clinic prior to renal replacement therapy and seven days using a home device, following the
sequence: baseline blood sample collection, anthropometric assessment, vital signs, BORG,
spirometry, mean quadriceps thickness, capacity functional status (six-minute step test),
cognitive status (Montreal Cognitive Assessment-BR), quality of life (Kidney Disease And
Quality-Of-Life Short Form), sleep quality (Pittsburgh Sleep Quality Index), state
motivational (Behavior Regulation Exercise Questionnaire - BREQ3), muscle strength and
endurance and daily physical activity. The sample calculation will be performed a posteriori,
with Gpower software, based on the variables of the six-minute step test and muscle
resistance value. Data will be systematized in the Statistical Package for Social Sciences
version 20.0. Initially, descriptive statistics will be performed. To characterize the
sample, the following variables will be considered: age, gender, anthropometric data,
spirometric parameters, body composition, urea and creatinine clearance, cognitive status.
Data distribution will be evaluated using the Shapiro-Wilk test or a non-parametric analogue.
To compare the response of the outcome variables between the groups, the ANOVA two-way test
of repeated measures, or a non-parametric analogue, will be used. To verify relationships
between numeric variables, Pearson's correlation coefficient or non-parametric analogue will
be used. The significance level adopted for the statistical treatment will be 5% (p < 0.05).
