An interventional study of Combined Training and Multicomponent Training in Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B and Chronic Kidney Disease, Non-dialysis, sponsored by University of Brasilia. Not yet recruiting at 1 site in Brazil. Open to participants aged 55 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by University of Brasilia · Not applicable, Interventional, and Treatment
This randomized controlled trial will compare the effects of 12 weeks of combined training (aerobic plus resistance exercise) and multicomponent training (aerobic plus resistance plus balance exercise) with a control group without supervised exercise in adults aged 55 to 70 years with chronic kidney disease (CKD) stages 3a or 3b who are not on dialysis. Fifty-seven participants will be randomly allocated (1:1:1) to one of the three groups. Supervised training sessions will last 60 minutes and will be held three times a week at the University of Brasilia, Brazil. The main questions are whether these programs improve peak oxygen uptake, resting blood pressure, physical health-related quality of life, and estimated glomerular filtration rate, and whether adding balance exercises provides additional benefits for balance, falls, and functional capacity.
Design: single-center, parallel-group (1:1:1) randomized controlled trial with blinded outcome assessors and a blinded statistical analyst. Randomization will be stratified by sex, in randomly sized blocks, with allocation concealed in sequentially numbered, sealed, opaque envelopes. Assessments will be performed at baseline and after the 12-week intervention across three visits (resting blood pressure, anamnesis, KDQOL-SF v1.3 and 30-second chair stand; fasting blood and urine collection, anthropometrics and DXA; handgrip strength, 8-Foot Up and Go, Mini-BESTest and maximal treadmill test with gas exchange analysis under physician supervision and 12-lead ECG monitoring). Falls will be recorded prospectively with monthly calendars in all groups. Statistical analysis: generalized estimating equations (GEE) with group, time, and group × time interaction, adjusted for sex, CKD stage (3a/3b), and type 2 diabetes; working correlation structure selected by QIC. Intention-to-treat is the primary analysis and per-protocol (≥75% adherence) the supportive analysis. Type I error across the five primary outcomes will be controlled by a pre-specified fixed-sequence (gatekeeping) procedure in the following order: VO2peak, resting systolic blood pressure, resting diastolic blood pressure, KDQOL-SF v1.3 physical component summary, and eGFR; each outcome is tested at alpha = 0.05 only if the previous one is significant. Pairwise comparisons will use GEE contrasts with Tukey adjustment. Effects will be reported as between-group differences in change with 95% confidence intervals (Mancl-DeRouen small-sample correction) and as standardized mean differences in change. Missing data will be addressed in a sensitivity analysis by multiple imputation by chained equations (20 datasets). Secondary outcomes are exploratory.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 57 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →University of Brasilia is the lead sponsor of 66 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
12-week supervised program of aerobic plus resistance exercise.
Behavioral: Combined Training
12-week supervised program of aerobic, resistance, and balance exercise.
Behavioral: Multicomponent Training
No supervised exercise during the 12 weeks; participants maintain their usual daily activities and are contacted every 4 weeks to record changes in medication and habits. After the post-intervention assessments, they will be offered one of the training programs for 12 weeks.
Three 60-minute supervised sessions per week (non-consecutive days) for 12 weeks, in groups of up to 10. Session: 5-min treadmill warm-up (RPE 9-11, Borg 6-20); 20-min aerobic treadmill exercise (weeks 1-4: continuous at RPE 13; weeks 5-8: 2 min at RPE 15 / 3 min at RPE 13; weeks 9-12: 3 min at RPE 15 / 2 min at RPE 13); 5-min cool-down; 25-min resistance training on machines (chest press, lat pulldown, abdominal crunch, leg press, hip abduction, hip adduction, plantar flexion; weeks 1-4: 2 x 10-12 reps at OMNI-RES 6; weeks 5-8: 2 x 8-10 at OMNI-RES 8; weeks 9-12: 3 x 6-8 at OMNI-RES 9); 5-min cool-down (slow walking, RPE 9). Sessions start only if blood pressure is below 160/105 mmHg.
Same frequency, duration, aerobic and resistance components, and progression as Combined Training, plus progressive balance exercises performed during rest intervals between resistance sets, without increasing session duration. Weeks 1-4: single-leg stance with support and eyes open, marching in place and knee/hip flexion with support; weeks 5-8: single-leg stance with eyes closed, straight-line and semi-tandem walking with and without support, single-leg hip flexion with support; weeks 9-12: tandem walking, forward stepping with trunk rotation, single-leg hops in different directions, hip hyperextension without support and with eyes closed, and combined movements on slightly unstable surfaces. Exercises are maintained in later mesocycles, progressing from supported to unsupported and from eyes open to eyes closed.
Peak Oxygen Uptake (VO2peak)
Highest 30-second average oxygen uptake during a maximal treadmill test (Bruce protocol) with breath-by-breath gas analysis (Cortex Metalyzer 3B), in mL/kg/min. First outcome in the pre-specified fixed-sequence testing hierarchy.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Resting Systolic Blood Pressure
Automatic upper-arm monitor (OMRON HBP-1120-BR); three readings at 1-minute intervals after 5 minutes of seated rest; mean of the last two readings, in mmHg. Second in the testing hierarchy.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Resting Diastolic Blood Pressure
Same procedure as systolic blood pressure, in mmHg. Third, in the testing hierarchy.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Physical Health-Related Quality of Life (KDQOL-SF v1.3 Physical Component Summary)
Physical Component Summary (PCS) of the SF-36 core of the Kidney Disease Quality of Life Short Form (KDQOL-SF v1.3, Brazilian version), reported as a single summary score on a norm-based T-score scale (general population mean 50, SD 10); higher scores indicate better physical health. Fourth in the testing hierarchy.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Estimated Glomerular Filtration Rate (eGFR)
eGFR by the race-free CKD-EPI 2021 creatinine-cystatin C equation, from fasting blood samples, in mL/min/1.73 m2. Fifth in the testing hierarchy.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Balance (Mini-BESTest)
Mini-Balance Evaluation Systems Test total score (0-28; higher = better balance), Brazilian Portuguese version.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Falls
Number of participants with at least one fall and fall incidence per group, recorded prospectively with monthly falls calendars (fall defined per ProFaNE consensus).
Time frame: During the 12-week intervention
Agility and Dynamic Balance (8-Foot Up and Go Test)
8-Foot Up and Go test; best time of two valid attempts, in seconds.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Handgrip Strength
Jamar dynamometer, dominant hand, best of three attempts, in kgf.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Lower-Limb Muscle Strength (30-Second Chair Stand Test)
30-second chair stand test, number of repetitions.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Mental Health-Related Quality of Life (KDQOL-SF v1.3 Mental Component Summary)
Mental Component Summary (MCS) of the SF-36 core of the KDQOL-SF v1.3, reported as a single summary score on a norm-based T-score scale (general population mean 50, SD 10); higher scores indicate better mental health.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Other KDQOL-SF v1.3 Dimensions
Scores (0-100) of the remaining generic and kidney disease-specific dimensions; higher scores indicate better quality of life.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Uremic Toxins and Kidney Markers
Serum urea, creatinine, and cystatin C; urinary albumin and protein (first-morning urine).
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Fasting Plasma Glucose
Fasting plasma glucose, in mg/dL.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c), in %.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Lipid Profile
Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides (mg/dL).
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Apolipoproteins
Apolipoprotein A-I and apolipoprotein B, as cardiovascular risk markers.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Inflammatory Markers
Interleukin-6, interleukin-10, tumor necrosis factor-alpha, and high-sensitivity C-reactive protein.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Vitamin D Status
Serum 25-hydroxyvitamin D.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Lean Mass
Whole-body lean mass assessed by dual-energy X-ray absorptiometry (DXA), in kg.Lean mass, fat mass, and body fat percentage (whole-body DXA).
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Fat Mass
Whole-body fat mass assessed by DXA, in kg.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Body Fat Percentage
Whole-body fat percentage assessed by DXA, in %.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Bone Mineral Density
BMD (g/cm2) at the lumbar spine (L1-L4), femoral neck, and one-third (33%) radius of the non-dominant forearm, by DXA.
Time frame: Week 0 (baseline) and week 13 (post-intervention)
Training Adherence
Percentage of the 36 prescribed sessions attended (CT and MCT groups).
Time frame: During the 12-week intervention
Adverse Events
Number and proportion of participants with adverse events, classified by severity, relationship to the intervention, and expectedness (CONSORT Harms 2022).
Time frame: During the 12-week intervention
Plan to share: Yes — De-identified individual participant data underlying the published results will be shared upon reasonable request to the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After publication of the main results.
Access criteria: Reasonable request to the principal investigator (Rochelle Rocha Costa) or to the central contact, with a data use agreement.
No publications or documents are linked to this record.
Start is estimated for May 2027; primary completion for Nov 2027, 6 months later.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 6 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Brasilia