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

6 de novembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

30 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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>

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Aerobic Exercise group

Participants assigned to this group will receive aerobic exercise training.
Outro: 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.
Experimental: Resistance Training group

Participants assigned to this group will receive resistance training.
Outro: 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.
Experimental: Combined Exercise group

Participants assignedto this group will receive combined aerobic andresistance exercise training.
Outro: 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.
Sem intervenção: control group

Participants received conventional health education.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Estimated glomerular filtration rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
6-minute walk test
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

China Institute of Sport Science

Colaboradores

Beijing Aerospace General Hospital

Investigadores

  • Investigador principal: Bin Zhang, PhD, China Institute of Sport Science

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de novembro de 2026

Conclusão Primária (Estimado)

15 de janeiro de 2028

Conclusão do estudo (Estimado)

15 de março de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CISS20250814
  • Project 25-02 (Número de outro subsídio/financiamento: The Fundamental Research Funds for the China Institute of Sport Science)
  • Project 26-15 (Número de outro subsídio/financiamento: The Fundamental Research Funds for the China Institute of Sport Science)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Data will be made available on request.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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