Different Exercise Modalities in Chronic Kidney Disease: A Longitudinal Intervention Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yuzhe Luo
- Número de teléfono: +86-10-87182619
- Correo electrónico: lyz2025m1@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100061
- Beijing Aerospace General Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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Experimental: 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. |
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Experimental: 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. |
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Sin intervención: control group
Participants received conventional health education. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Estimated glomerular filtration rate
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Renal resistance index
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Serum creatinine
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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The four standard blood lipid parameters
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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blood glucose
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Urinary protein
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Urinary albumin-to-creatinine ratio
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Endogenous Creatinine Clearance
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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6-minute walk test
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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30-second sit-to-stand test
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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vital capacity
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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Vital capacity will be measured using a standardized spirometer. |
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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grip strength
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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Handgrip strength will be assessed using a calibrated handgrip dynamometer |
Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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Body fat percentage
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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malondialdehyde
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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superoxide dismutase
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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glutathione peroxidase
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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C-reactive protein
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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interleukin-6
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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tumor necrosis factor-α
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Interleukin-10
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Transforming growth factor-β1
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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connective tissue growth factor
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Short Form-36 Health Survey
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Renal blood flow
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Peak systolic velocity
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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end-diastolic velocity
Periodo de tiempo: Baseline and at 2, 4, 6, and 12 months after initiation of the intervention
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Bin Zhang, PhD, China Institute of Sport Science
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Condiciones Patológicas, Signos y Síntomas
- Inflamación
- Insuficiencia renal
- Insuficiencia Renal Crónica
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- CISS20250814
- Project 25-02 (Otro número de subvención/financiamiento: The Fundamental Research Funds for the China Institute of Sport Science)
- Project 26-15 (Otro número de subvención/financiamiento: The Fundamental Research Funds for the China Institute of Sport Science)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Data will be made available on request.
Información sobre medicamentos y dispositivos, documentos del estudio
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