Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Resistance Exercise Group (Group A)
Participants in this arm engaged in supervised resistance training three times per week for six months. Each session included:
5-minute warm-up with dynamic stretching and range-of-motion exercises
30-minute resistance training using weight machines targeting major muscle groups (upper limbs, lower limbs, and trunk)
Intensity: 60% to 80% of one-repetition maximum (1-RM), adjusted progressively
10-minute cool-down with static stretching Sessions were monitored by trained physiotherapists.
干预措施: Resistance Exercise (Behavioral)
Aerobic Exercise Group (Group B)
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.
干预措施: Aerobic Training (Behavioral)
结局指标
主要结局
Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations
时间窗: 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.
Change in Bone Mineral Density (BMD)
时间窗: 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.
Change in OPG/RANKL Ratio
时间窗: 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
次要结局
- Change in eGFR (estimated Glomerular Filtration Rate)(Baseline to 6 months)
- Change in Serum Albumin and Hemoglobin Levels(Baseline to 6 months)
研究者
Amany Gomaa Atiaa
lecturer
Sinai University