Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Different Exercise Modalities in Chronic Kidney Disease: A Longitudinal Intervention Study

6 november 2026 bijgewerkt door: China Institute of Sport Science

A Randomized Controlled Trial of Different Exercise Modalities in Patients With Chronic Kidney Disease: A Longitudinal Study of Renal Outcomes and Potential Mechanisms

This study compares the effects and safety of aerobic, resistance, and combined exercise versus routine health education on renal function, physical function, and quality of life in people with Chronic kidney disease (CKD) over 12 months, while exploring potential mechanisms.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A total of 120 adults with Chronic kidney disease (CKD) stages G1-G4 will participate in this randomized controlled trial to evaluate the effects and safety of different exercise modalities on renal function, physical function, and quality of life, and to explore potential mechanisms related to renal hemodynamics, inflammation, and oxidative stress. Participants will be randomly assigned to aerobic exercise, resistance exercise, combined exercise, or control groups, with 30 participants planned per group. The study will last 12 months, with assessments at baseline and months 2, 4, 6, and 12.<br> <br> Participants in the exercise groups will complete three approximately 60-minute sessions weekly, including at least one supervised in-person session and remotely monitored sessions. Aerobic exercise will target 55-80% of estimated maximum heart rate. Resistance exercise will use resistance bands and body weight, with intensity adjusted according to individual ability and perceived exertion. The combined group will perform two aerobic and one resistance session weekly. The control group will receive routine CKD health education without structured exercise training during the study.<br> <br> Primary outcomes include renal function and metabolic parameters. Secondary outcomes include physical function, body composition, and quality of life. Exploratory assessments will examine renal hemodynamics, inflammatory markers, oxidative stress, and fibrosis-related biomarkers. Exercise participation and adherence will be monitored, and adverse events will be recorded in all groups. Serious adverse events will be managed according to the study protocol and applicable ethics requirements.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100061
        • Beijing Aerospace General Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar tot 60 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

<p style="line-height: 2.5;">

  • Aged 30-60 years, of either sex.
  • Meets the CKD diagnostic criteria in the Kidney Disease: Improving Global Outcomes (KDIGO) guidance and the 2023 Expert Recommendations on the Clinical Pathway for Early Screening of Chronic Kidney Disease (CKD) and Its Complications in Chinese Adults. Two categories of participants will be included: individuals with early-stage CKD, stages G1 and G2, with an estimated glomerular filtration rate (eGFR) of 60-90 mL/min/1.73 m²; and individuals with established CKD, stages G3 and G4, with an eGFR of 15-59 mL/min/1.73 m², who have been assessed by a clinician as able to participate in exercise.
  • Clinically stable, with no dialysis or kidney transplantation within the previous six months.
  • No severe cardiopulmonary dysfunction or other contraindications to exercise.
  • Sufficient cognitive ability to comply with the intervention plan.
  • Willing to participate in the study and provide written informed consent. </p>

Exclusion Criteria:

<p style="line-height: 2.5;">

  • Acute kidney failure; severe hypertension (above 180/110 mmHg); diabetes; heart failure; acute infection; malignancy; or active immune disease.
  • Participation in another clinical trial or structured exercise intervention program within the previous three months.
  • Severe edema, musculoskeletal disease, or other conditions that prevent participation in exercise.
  • Body mass index (BMI)≥35 kg/m².
  • Pregnancy or plans to become pregnant.
  • Severe cognitive impairment or inability to cooperate with the study. </p>

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Aerobic Exercise group

Participants assigned to this group will receive aerobic exercise training.
Ander: Aerobic Exercise

Participants will undergo aerobic exercise training three times per week for 12 months, with each session lasting approximately 60 minutes. Training will consist primarily of aerobic movements, including high knees, half-squat jumping jacks, boxing steps, V-steps with arm movements, knee lifts with torso rotation, and jumping jacks. Exercise intensity will be targeted at 55%-80% of age-predicted maximum heart rate calculated using the Tanaka formula. Heart rate and session duration will be monitored using a Huawei fitness band. Exercise intensity and difficulty will be individually adjusted according to exercise tolerance and training performance. Progression may involve increasing exercise duration, movement speed, or exercise difficulty. Sessions will include 3-5 minutes of warm-up and 3-5 minutes of cool-down and stretching.
Experimenteel: Resistance Training group

Participants assigned to this group will receive resistance training.
Ander: resistance training

Participants will undergo progressive resistance training three times per week for 12 months, with each session lasting approximately 60 minutes. Training will primarily use resistance bands and bodyweight exercises, including resistance-band chest presses, resistance-band rows, squats, and other exercises adapted to individual physical capacity. Resistance and exercise difficulty will be selected according to baseline exercise capacity and training experience. The target intensity will be adjusted using the rating of perceived exertion (RPE), with participants performing 10-15 repetitions to a level at which the exercise feels substantially effortful. Training will begin with lower resistance and fewer sets, with progressive increases in resistance or sets according to individual tolerance and performance. Exercise completion, resistance, repetitions, fatigue, and discomfort will be recorded throughout the intervention.
Experimenteel: Combined Exercise group

Participants assignedto this group will receive combined aerobic andresistance exercise training.
Ander: Combined Exercise

Participants will undergo combined exercise training three times per week for 12 months, with each session lasting approximately 60 minutes. The weekly program will include two aerobic exercise sessions and one resistance exercise session. Aerobic training will use movements such as high knees, half-squat jumping jacks, boxing steps, V-steps with arm movements, knee lifts with torso rotation, and jumping jacks, with intensity targeted at 55%-80% of age-predicted maximum heart rate calculated using the Tanaka formula. Resistance training will use resistance bands and bodyweight exercises, with intensity adjusted according to the rating of perceived exertion (RPE) and individual exercise capacity. Exercise intensity and difficulty will be progressively adjusted according to tolerance and performance. Heart rate, session duration, exercise completion, and training-related discomfort will be monitored and recorded.
Geen tussenkomst: control group

Participants received conventional health education.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Estimated glomerular filtration rate
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Estimated glomerular filtration rate will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Renal resistance index
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The renal resistance index (RI) will be assessed by qualified physicians using Doppler ultrasonography of the bilateral interlobar arteries. Measurements will be obtained at standardized sampling sites in both kidneys, with a sampling gate of 2-4 mm and a Doppler angle of less than 60°.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Serum creatinine
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Serum creatinine will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
The four standard blood lipid parameters
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The four standard blood lipid parameters, including total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C), will be measured using blood samples collected from participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
blood glucose
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

blood glucose will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Urinary protein
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Urinary protein levels will be measured using urine samples collected from participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Urinary albumin-to-creatinine ratio
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

The urinary albumin-to-creatinine ratiowill be measured using urine samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Endogenous Creatinine Clearance
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Endogenous creatinine clearance will be measured using urine samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-minute walk test
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Participants will walk as far as possible at their maximum tolerable pace within 6 minutes, and the total distance walked will be recorded.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
30-second sit-to-stand test
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Participants will complete as many sit-to-stand repetitions as possible within 30 seconds, and the total number of completed repetitions will be recorded.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
vital capacity
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Vital capacity will be measured using a standardized spirometer.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
grip strength
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Handgrip strength will be assessed using a calibrated handgrip dynamometer
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Body fat percentage
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Body fat percentage will be measured using an InBody body composition analyzer.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
malondialdehyde
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Malondialdehyde will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
superoxide dismutase
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Superoxide dismutase will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
glutathione peroxidase
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Glutathione peroxidase will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
C-reactive protein
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

C-reactive protein will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
interleukin-6
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

interleukin-6 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
tumor necrosis factor-α
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Tumor necrosis factor-α will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Interleukin-10
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Interleukin-10 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Transforming growth factor-β1
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Transforming growth factor-β1 will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
connective tissue growth factor
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Connective tissue growth factor will be measured using blood samples collected from the participants.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Short Form-36 Health Survey
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Short Form-36 Health Survey will be assessed using a questionnaire.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Renal blood flow
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Renal blood flow will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
Peak systolic velocity
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Peak systolic velocity will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
end-diastolic velocity
Tijdsspanne: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

end-diastolic velocity will be assessed by qualified physicians using ultrasonography.
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

China Institute of Sport Science

Medewerkers

Beijing Aerospace General Hospital

Onderzoekers

  • Hoofdonderzoeker: Bin Zhang, PhD, China Institute of Sport Science

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 november 2026

Primaire voltooiing (Geschat)

15 januari 2028

Studie voltooiing (Geschat)

15 maart 2028

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CISS20250814
  • Project 25-02 (Ander subsidie-/financieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 26-15 (Ander subsidie-/financieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Data will be made available on request.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren