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

6 listopada 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

30 lat do 60 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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>

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Aerobic Exercise group

Participants assigned to this group will receive aerobic exercise training.

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.

Eksperymentalny: Resistance Training group

Participants assigned to this group will receive 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.

Eksperymentalny: Combined Exercise group

Participants assignedto this group will receive combined aerobic andresistance exercise training.

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.

Brak interwencji: control group

Participants received conventional health education.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Estimated glomerular filtration rate
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
6-minute walk test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Śledczy

  • Główny śledczy: Bin Zhang, PhD, China Institute of Sport Science

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 listopada 2026

Zakończenie podstawowe (Szacowany)

15 stycznia 2028

Ukończenie studiów (Szacowany)

15 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

6 listopada 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 listopada 2026

Pierwszy wysłany (Rzeczywisty)

12 listopada 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • CISS20250814
  • Project 25-02 (Inny numer grantu/finansowania: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 26-15 (Inny numer grantu/finansowania: The Fundamental Research Funds for the China Institute of Sport Science)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Data will be made available on request.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .