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

NCT ID: NCT07133256

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-25

Brief Summary

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.

Detailed Description

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.

Conditions

Osteopenia; Bone Metabolism Disorders; Chronic Kidney Disease (Stage 3-4); Mineral and Bone Disorder (CKD-MBD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance Exercise

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Aerobic Training

Intervention Type: 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.

Interventions

Resistance Exercise

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.

Intervention Type: BEHAVIORAL

Aerobic Training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinai University

OTHER

Sponsor Role: lead

Responsible Party

Amany Gomaa Atiaa

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Shehab Abd E-Kader, Professor

Role: PRINCIPAL_INVESTIGATOR

1Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.

Locations

Manshyet El-Bakry Hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

SU.REC.2025(45H)

Identifier Type: -

Identifier Source: org_study_id