An interventional study of Aerobic exercise in Chronic Kidney Diseases, sponsored by University of the State of Santa Catarina. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by University of the State of Santa Catarina · Not applicable, Interventional, and Treatment
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:
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).
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's planned enrollment of 90 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →University of the State of Santa Catarina is the lead sponsor of 25 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
Aerobic exercise training on moderate intensity.
Other: Aerobic exercise
Monitoring.
The training group will receive aerobic exercise and the intensities will be controlled considering the percentage of estimated maximum heart rate. The training will be performed with a cycle ergometer with a total of 40 minutes of intradialytic aerobic exercise in the training group. To reduce the effects of intolerance to aerobic exercise, a week of adaptation will be performed, with a frequency of three sessions, in the first two hours of hemodialysis, lasting 40 minutes at maximum heart rate intensity of up to 74% and BORG up to 4 (low intensity). Afterwards, the patients will perform the prediction training for 12 weeks, at the frequency of three training sessions per week in the first two hours of hemodialysis. Each training session will start with a 5-minute warm-up at low intensity, 30 minutes of main training with maximum heart rate intensity 55% to 74% and BORG 5 to 7 (moderate intensity) and will end with a 5-minute cool-down at low intensity.
six minute step test
A step 20 centimeters high will be used and the patient will be instructed to go up and down it as many times during the 6 minutes, according to free cadence and will be instructed not to use the upper limbs
Time frame: 12 weeks
muscle strength
measured by dynamometry, the records will be in newtons.
Time frame: 12 weeks
Daily life physical activity
number of steps for seven days by triaxial accelerometer
Time frame: 12 weeks
Behavior Regulation Questionnaire for Physical Exercise
The questionnaire ranges from 0 to 24 for self-regulation indices and 0 to 4 for each type of regulation, namely external, introjected, identified, integrated and intrinsic regulation
Time frame: 12 weeks
index of self-determination and basic psychological needs
The score varies from 1 to 5, with 1 being total disagreement and 5 total agreement for variables related to the link between competence and autonomy.
Time frame: 12 weeks
Pittsburg Sleep Quality Index
The questionnaire quantifies sleep quality, calculated between seven skills. The final result varies from good sleep quality (0-4), poor sleep quality (5-10) and the presence of sleep disorders (above 10).
Time frame: 12 weeks
Montreal Cognitive Assessment
8 cognitive domains (visual-spatial execution, naming, memory, attention, language, abstraction, delayed recall and orientation), with a score from 0 to 30. The cut-off point for renal hemodialysis patients is less than or equal to 24, and the the higher the score, the better the vascular cognitive function
Time frame: 12 weeks
blood sample
The analyzes carried out will be regarding the marker of muscle trophism (insulin-like growth factor type 1), pro-inflammatory cytokines (tumor necrosis factor - TNF-alpha) and anti-inflammatory cytokines (interleukin 10 - IL-10).
Time frame: 12 weeks
lower limb resistance
Measured by dynamometry, the records will be in tolerated seconds.
Time frame: 12 weeks
Kidney Disease and Quality-of-Life - Short Form
eight dimensions, ten items for physical functioning, four items for limitations caused by physical health problems, three items for limitations caused by emotional health problems, two items for social functioning, five items for mental health, two items for pain, four items for vitality, energy and fatigue, five items for perceptions of general health and one item for current health status compared to a year ago, which is computed separately.The degree of commitment is measured using values ranging from zero (highest degree of commitment) to 100 (no commitment). Therefore, the higher the score obtained, the better the quality of life.
Time frame: 12 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →
University of the State of Santa Catarina