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Chronic Kidney Disease Stage 3ANCT07901621

Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b

A study testing Combined Training and Multicomponent Training in people with Chronic Kidney Disease Stage 3A and Chronic Kidney Disease Stage 3B, run by University of Brasilia at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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)… Read more about this study

Who is it for?
Ages 55 to 70 years
What is being tested?
Combined Training and Multicomponent Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteBrazil
Study dates
May 2027to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CKD stage 3a or 3b (eGFR 30-59 mL/min/1.73 m2) according to KDIGO 2024, diagnosed at least 6 months before enrollment
  • Age between 55 and 70 years
  • Body mass index between 18.5 and 35 kg/m2
  • No participation in a structured exercise program in the previous 3 months
  • Controlled systemic arterial hypertension and/or type 2 diabetes mellitus are allowed
  • No clinical contraindication to exercise training or to the study assessments
  • Literacy sufficient to understand the informed consent form and questionnaires

Who cannot join

  • CKD stages 1, 2, 4, or 5, dialysis, or kidney transplantation
  • Polycystic kidney disease
  • Congestive heart failure, advanced chronic obstructive pulmonary disease, heart disease, arrhythmias, unstable angina, or type 1 diabetes mellitus
  • Dementia or psychiatric disorders that compromise understanding of instructions or safe exercise
  • Musculoskeletal injuries or neurological disorders that prevent participation in the exercise program
  • Concurrent participation in another supervised exercise program

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brazil1 site
  • University of Brasilia - Faculty of Physical Education and Olympic Center

    Brasília, Federal District, 70910-900

Other trials in Brazil

About this study

Official title: Effects of Combined and Multicomponent Training on Physiological, Functional, and Quality of Life Parameters in People With Chronic Kidney Disease: A Randomized Controlled Clinical Trial

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.

Read the detailed description

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.

Being tested
Combined Training, Multicomponent Training
Keywords
Renal Insufficiency, Chronic, Exercise Therapy, Resistance Training, Postural Balance, Glomerular Filtration Rate, Blood Pressure, Accidental Falls, Quality of Life, Oxygen Consumption, Multicomponent Training, Combined Training
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combined TrainingBehavioural

    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.

  • Multicomponent TrainingBehavioural

    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.

Study groups in NCT07901621
Study groupRoleWhat they receive
Combined TrainingExperimental12-week supervised program of aerobic plus resistance exercise.
Receives: Behavioral: Combined Training
Multicomponent TrainingExperimental12-week supervised program of aerobic, resistance, and balance exercise.
Receives: Behavioral: Multicomponent Training
Control GroupNo interventionNo 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  2. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  3. Resting Diastolic Blood Pressure

    Same procedure as systolic blood pressure, in mmHg. Third, in the testing hierarchy.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  4. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  5. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

Secondary outcomes (20)
  1. Balance (Mini-BESTest)

    Mini-Balance Evaluation Systems Test total score (0-28; higher = better balance), Brazilian Portuguese version.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  2. 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).

    Measured: During the 12-week intervention

  3. Agility and Dynamic Balance (8-Foot Up and Go Test)

    8-Foot Up and Go test; best time of two valid attempts, in seconds.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  4. Handgrip Strength

    Jamar dynamometer, dominant hand, best of three attempts, in kgf.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  5. Lower-Limb Muscle Strength (30-Second Chair Stand Test)

    30-second chair stand test, number of repetitions.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  6. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  7. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  8. Uremic Toxins and Kidney Markers

    Serum urea, creatinine, and cystatin C; urinary albumin and protein (first-morning urine).

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  9. Fasting Plasma Glucose

    Fasting plasma glucose, in mg/dL.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  10. Glycated Hemoglobin (HbA1c)

    Glycated hemoglobin (HbA1c), in %.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  11. Lipid Profile

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides (mg/dL).

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  12. Apolipoproteins

    Apolipoprotein A-I and apolipoprotein B, as cardiovascular risk markers.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  13. Inflammatory Markers

    Interleukin-6, interleukin-10, tumor necrosis factor-alpha, and high-sensitivity C-reactive protein.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  14. Vitamin D Status

    Serum 25-hydroxyvitamin D.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  15. 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).

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  16. Fat Mass

    Whole-body fat mass assessed by DXA, in kg.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  17. Body Fat Percentage

    Whole-body fat percentage assessed by DXA, in %.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  18. 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.

    Measured: Week 0 (baseline) and week 13 (post-intervention)

  19. Training Adherence

    Percentage of the 36 prescribed sessions attended (CT and MCT groups).

    Measured: During the 12-week intervention

  20. Adverse Events

    Number and proportion of participants with adverse events, classified by severity, relationship to the intervention, and expectedness (CONSORT Harms 2022).

    Measured: During the 12-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study startMay 2027 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three parallel groups (combined training, multicomponent training, control) with 1:1:1 allocation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07901621
Sponsor's protocol ID
95109225.3.0000.5558
Status last verified
Oct 2026
First submitted
21 Oct 2026
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results will be shared upon reasonable request to the principal investigator.

Questions about this trial

What is this clinical trial studying?

A study testing Combined Training and Multicomponent Training in people with Chronic Kidney Disease Stage 3A and Chronic Kidney Disease Stage 3B, run by University of Brasilia at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cosme R Lara (+55 61 97400-1592, cosmerlara@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Oxygen Uptake (VO2peak) (time frame: Week 0 (baseline) and week 13 (post-intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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