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

6. november 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

30 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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>

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Aerobic Exercise group

Participants assigned to this group will receive aerobic exercise training.
Annen: 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.
Eksperimentell: Resistance Training group

Participants assigned to this group will receive resistance training.
Annen: 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.
Eksperimentell: Combined Exercise group

Participants assignedto this group will receive combined aerobic andresistance exercise training.
Annen: 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.
Ingen inngripen: control group

Participants received conventional health education.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Estimated glomerular filtration rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6-minute walk test
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

China Institute of Sport Science

Samarbeidspartnere

Beijing Aerospace General Hospital

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. november 2026

Primær fullføring (Antatt)

15. januar 2028

Studiet fullført (Antatt)

15. mars 2028

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CISS20250814
  • Project 25-02 (Annet stipend/finansieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 26-15 (Annet stipend/finansieringsnummer: The Fundamental Research Funds for the China Institute of Sport Science)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Data will be made available on request.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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