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This randomized controlled trial was designed to investigate the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants underwent a detailed medical history assessment, clinical examination, and dietary evaluation. Individuals who met the inclusion criteria provided written informed consent prior to participation. All procedures were conducted in accordance with the Declaration of Helsinki, and the study protocol was approved by the Ethics Committee of Manouba University (no. C.S. ISSEP.KS NËš040/2024).
Eligible participants were randomly allocated to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the EXP group participated in supervised PRT sessions combined with a Mediterranean diet intervention, while the CON group received no structured intervention.
Detailed Description
This randomized controlled trial was conducted to examine the effects of progressive resistance training (PRT) combined with a Mediterranean diet on bone mineral density (BMD) and bone turnover markers (BTMs) in older adults.
Participants were recruited and screened through a detailed medical history assessment, clinical examination, and dietary evaluation. Eligible individuals who met the inclusion criteria provided written informed consent before participation.
Participants were randomly assigned to either the experimental group (EXP; n = 22) or the control group (CON; n = 19). The intervention lasted 12 months. During this period, the experimental group participated in supervised progressive resistance training sessions combined with a Mediterranean diet intervention, while the control group received no structured intervention and maintained their usual lifestyle.
Bone mineral density and bone turnover markers were assessed at baseline and after the 12-month intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet + Progressive Resistance Training | Experimental | Participants followed a Mediterranean diet combined with a supervised progressive resistance training program performed three times per week for 12 months. |
|
| Control Group | No Intervention | No Structured Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet combined with Resistance Training | Behavioral | Participants followed a Mediterranean diet and engaged in a supervised progressive resistance training program performed three times per week for 12 months. The training was progressively adapted based on individual capacity, focusing on major muscle groups using standard resistance exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density (BMD) | Bone mineral density (BMD) was assessed using dual-energy X-ray absorptiometry (DXA) at the lumbar spine and femoral neck. Measurements were performed at baseline and after the 12-month intervention period. esults will be reported as BMD values expressed in g/cm². | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone Formation Markers | Bone formation marker, osteocalcin were assessed in fasting blood samples. Unit of Measure: ng/mL | Baseline and 12 months |
| Bone Formation Markers | Bone-specific alkaline phosphatase (BAP) were assessed in fasting blood samples. Unit of Measure: U/L |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antonella MUSCELLA | Lecce | LE | 73100 | Italy |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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1) an intervention group receiving both a Mediterranean diet and supervised progressive resistance training, and (2) a control group receiving no structured intervention.
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|
|
| Baseline and 12 months |
| Bone Formation Markers | Fasting serum P1NP concentrations will be assessed as a marker of bone formation. were assessed in fasting blood samples. Unit of Measure: ng/mL | Baseline and 12 months |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |