OsteopeniaCKD-BONE-EXNCT07133256
Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease
A study testing Resistance Exercise and Aerobic Training in people with Osteopenia and Bone Metabolism Disorders, run by Sinai University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Osteopenia, Bone Metabolism Disorders, Chronic Kidney Disease (Stage 3-4)
- What is being tested?
- Resistance Exercise and Aerobic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 25 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease: A Randomized Controlled Trial
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.
- Conditions
- Osteopenia, Bone Metabolism Disorders, Chronic Kidney Disease (Stage 3-4), Mineral and Bone Disorder (CKD-MBD)
- Being tested
- Resistance Exercise, Aerobic Training
- Keywords
- Chronic kidney disease, RANKL, OPG/RANKL Ratio, Osteoprotegerin, Aerobic Exercise, Resistance Exercise, Bone mineral density
- Medical subject headings
- Bone Diseases, Metabolic, Renal Insufficiency, Chronic, Calcinosis, Bone Diseases, Chronic Kidney Disease-Mineral and Bone Disorder, Osteopetrosis, mild autosomal recessive form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Aerobic Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 6 months post-intervention
Change in OPG/RANKL Ratio
Baseline to 6 months post-intervention
Measured: 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)
To explore the potential renal benefits of structured exercise in CKD patients. Measured in mL/min/1.73 m².
Measured: Baseline to 6 months
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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional (Clinical Trial)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
- Investigators
- Dr. Shehab Abd E-Kader, Professor, Principal investigator, 1Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133256
- Sponsor's protocol ID
- SU.REC.2025(45H)
- Acronym
- CKD-BONE-EX
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07133256
- Acronym / sponsor ID
- CKD-BONE-EX / SU.REC.2025(45H)
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise Group (Group A) | Experimental | Behavioral: Resistance ExerciseParticipants 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. |
| Aerobic Exercise Group (Group B) | Active comparator | Behavioral: Aerobic TrainingParticipants 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance ExerciseStructured 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. | Behavioural | Resistance Exercise Group (Group A) |
| Aerobic TrainingParticipants 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. | Behavioural | Aerobic Exercise Group (Group B) |
Primary outcome
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.
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.
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
2 secondary outcomes
Change in eGFR (estimated Glomerular Filtration Rate)
Time frame: Baseline to 6 months
Change in Serum Albumin and Hemoglobin Levels
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shehab Abd E-Kader, Professor principal investigator
1Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and Aerobic Training in people with Osteopenia and Bone Metabolism Disorders, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations (time frame: Baseline to 6 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.