ClinicalTrials.gg
CompletedNCT07133256CKD-BONE-EXUpdated Aug 21, 2025

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

An interventional study of Resistance Exercise and Aerobic Training in Osteopenia, Bone Metabolism Disorders and Chronic Kidney Disease (Stage 3-4), sponsored by Sinai University. Completed at 1 site in Egypt. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-21.

Primary conditionChronic Kidney Disease-Mineral and Bone DisorderRegistry: Bone Diseases, MetabolicReclassifiedWhy we changed it
Registry
Bone Diseases, Metabolic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Chronic Kidney Disease-Mineral and Bone Disorder
Why
  1. The study's listed conditions name Chronic Kidney Disease-Mineral and Bone Disorder, a narrower term within Bone Diseases, Metabolic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Sinai University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2025, registered Aug 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Chronic Kidney Disease-Mineral and Bone Disorder Reclassified

73 studies on the registry are indexed under Chronic Kidney Disease-Mineral and Bone Disorder; 20 are open to participants now.

This study's enrollment of 60 is above the median of 54 across 34 interventional studies indexed under Chronic Kidney Disease-Mineral and Bone Disorder.

Browse Chronic Kidney Disease-Mineral and Bone Disorder studies →

Lead sponsor

Sinai University is the lead sponsor of 24 studies on the registry; 11 are open to participants now.

Compared within Chronic Kidney Disease-Mineral and Bone Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bone Diseases, Metabolic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 30 to 50 years
  • Diagnosed with stage 3 or 4 chronic kidney disease (non-dialysis dependent)
  • between 20 and 24 kg/m²
  • Not currently taking medications that affect bone density (e.g., , 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

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
  • to exercise as determined by medical evaluation
  • Use of drugs or enrollment in another clinical trial during the study period
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Resistance Exercise

  • Active comparator
    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.

    Behavioral: Aerobic Training

Interventions

  • BehavioralResistance 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.

  • BehavioralAerobic 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 months post-intervention

  2. 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.

    Time frame: Baseline to 6 months post-intervention

  3. Change in OPG/RANKL Ratio

    Baseline to 6 months post-intervention

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

Secondary outcomes

  1. Change in eGFR (estimated Glomerular Filtration Rate)

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

    Time frame: Baseline to 6 months

  2. Change in Serum Albumin and Hemoglobin Levels

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

    Time frame: Baseline to 6 months

07

Study locations

1 site
  • Manshyet El-Bakry Hospital
    Cairo, 44511, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07133256
Lead sponsor
Sinai University
Responsible party
Amany Gomaa Atiaa (lecturer, Sinai University) — Principal investigator
First posted
Aug 21, 2025
Start date
Jan 1, 2025
Primary completion
Jul 1, 2025
Completion
Jul 25, 2025
Last update
Aug 21, 2025

Study contacts

Dr. Shehab Abd E-Kader, Professor
principal investigator · 1Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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