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

NCT07133256 | Completed DMC

• 1 other identifier: SU.REC.2025(45H)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chronic kidney disease; RANKL, OPG/RANKL Ratio; Osteoprotegerin; Aerobic Exercise; Resistance Exercise; Bone mineral density

Outcome Measures

Primary Outcomes (3)

• Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations

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

  Baseline to 6 months post-intervention

• Change in Bone Mineral Density (BMD)

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

  Baseline to 6 months post-intervention

• Change in OPG/RANKL Ratio

  Baseline to 6 months post-intervention

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

Secondary Outcomes (2)

• Change in eGFR (estimated Glomerular Filtration Rate)

  Baseline to 6 months

• Change in Serum Albumin and Hemoglobin Levels

  Baseline to 6 months

Study Arms (2)

Resistance Exercise Group (Group A)

EXPERIMENTAL

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.

Behavioral: Resistance Exercise

Aerobic Exercise Group (Group B)

ACTIVE COMPARATOR

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.

Behavioral: Aerobic Training

Interventions

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.

Resistance Exercise Group (Group A)

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.

Aerobic Exercise Group (Group B)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: 30 to 50
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Manshyet El-Bakry Hospital

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Renal Insufficiency, Chronic; Calcinosis; Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder; Osteopetrosis, mild autosomal recessive form

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Rickets; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr. Shehab Abd E-Kader, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Interventional (Clinical Trial)

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 21, 2025
• Study Start: January 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 25, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

EG (1)