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NCT Number: NCT07133256

Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease

This randomized controlled trial investigates the comparative effects of aerobic versus resistance training on bone mineral density (BMD) and bone metabolism markers in patients with stage 3 or 4 chronic kidney disease (CKD). The primary aim is to evaluate the impact of two distinct exercise modalities on serum osteoprotegerin (OPG), receptor activator of nuclear factor kappa-B ligand (RANKL), and the OPG/RANKL ratio, as well as densitometric changes at key skeletal sites.

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Key information

Conditions

Osteopenia Avitaminosis Bone Diseases Bone Diseases, Metabolic Bone Metabolism Disorders Calcinosis Calcium Metabolism Disorders Chronic Disease Chronic Kidney Disease (Stage 3-4) Chronic Kidney Disease-Mineral and Bone Disorder Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hyperparathyroidism, Secondary Kidney Diseases Male Urogenital Diseases Malnutrition Metabolic Diseases Mineral and Bone Disorder (CKD-MBD) Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Osteopetrosis, mild autosomal recessive form Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Rickets Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manshyet El-Bakry Hospital

Cairo, 44511, Egypt

About this study

Chronic kidney disease-mineral and bone disorder (CKD-MBD) is a common complication in non-dialysis CKD patients, driven by disrupted calcium-phosphate metabolism, secondary hyperparathyroidism, and altered bone remodeling pathways, such as the OPG-RANKL axis. Exercise is an emerging non-pharmacological strategy to mitigate skeletal deterioration in CKD, yet the differential effects of aerobic and resistance training on bone health remain poorly understood in this population.

This study recruited 60 CKD patients (stage 3-4, aged 30-50 years) and randomly allocated them into two groups (n=30 each): a resistance training group and an aerobic exercise group. Both groups underwent supervised exercise 3 times per week for six months. Bone mineral density was assessed using dual-energy X-ray absorptiometry (DEXA) at the lumbar spine (L2-L4), femoral neck, and distal radius. Serum concentrations of OPG and RANKL were measured via ELISA at baseline and post-intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 30 to 50 years
  • Diagnosed with stage 3 or 4 chronic kidney disease (non-dialysis dependent)
  • BMI between 20 and 24 kg/m²
  • Not currently taking medications that affect bone density (e.g., corticosteroids, bisphosphonates)
  • Non-smokers and abstinent from alcohol
  • Not receiving hormone replacement therapy
  • Willing and able to participate in supervised exercise sessions for 6 months

Exclusion criteria

  • Diagnosis of type 1 diabetes mellitus
  • Uncontrolled hypertension
  • History of cardiovascular, musculoskeletal, endocrine, or metabolic bone disease
  • Pregnant or planning pregnancy during the study period
  • Participation in a structured exercise program within the last 3 months
  • Contraindications to exercise as determined by medical evaluation
  • Use of investigational drugs or enrollment in another clinical trial during the study period

Treatment and study plan

Resistance exercise

Behavioral

Structured machine-based resistance exercise protocol performed under supervision, targeting osteogenic loading to improve bone mineral density and alter bone metabolism markers in CKD stage 3-4 patients.

Aerobic training

Behavioral

Participants in this arm performed supervised aerobic exercise (treadmill walking) three times per week for six months. Each session included:

5-minute warm-up

30-minute treadmill walking at 60%-80% of age-predicted maximum heart rate (HRmax = 220 - age)

10-minute cool-down Exercise sessions were supervised by trained exercise professionals and tailored to maintain target heart rate zones.

Primary outcomes

  1. Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations

    Time frame: Baseline to 6 months post-intervention

    To determine biochemical changes in bone metabolism markers. Both OPG (pg/mL) and RANKL (ng/mL) are measured using validated ELISA kits.

  2. Change in Bone Mineral Density (BMD)

    Time frame: Baseline to 6 months post-intervention

    To assess densitometric changes in skeletal structure due to exercise. BMD is measured in g/cm² using ISCD-certified DEXA equipment.

  3. Change in OPG/RANKL Ratio

    Time frame: To assess the regulatory balance of bone remodeling. A higher OPG/RANKL ratio reflects reduced osteoclastic activity and improved bone metabolic status.

    Baseline to 6 months post-intervention

Secondary outcomes

  1. Change in eGFR (estimated Glomerular Filtration Rate)

    Time frame: Baseline to 6 months

    To explore the potential renal benefits of structured exercise in CKD patients. Measured in mL/min/1.73 m².

  2. Change in Serum Albumin and Hemoglobin Levels

    Time frame: Baseline to 6 months

    These indicators provide information about overall nutritional and hematologic status. Albumin (g/dL) and Hemoglobin (g/dL) are assessed via standard lab procedures.

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Registry information

Official study title

Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease: A Randomized Controlled Trial

Acronym: CKD-BONE-EX

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2025
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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