NCT06505044

Brief Summary

Osteoporosis is a significant public health issue, especially among postmenopausal women with diabetes, and its prevalence is increasing. This trial aims to determine the influence of moderate intensity aerobic exercise vs resistance exercise on bone mineral density among postmenopausal diabetic women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

July 2, 2024

Last Update Submit

September 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The bone mineral density (BMD)

    • Dual Energy X-ray Absorptiometry (DEXA). It was used to measure the bone mineral density (BMD) of the lumbar spine for each woman in both groups before and after the study.

    3 months

Study Arms (2)

Group (A)

EXPERIMENTAL

25 patients receive aerobic exercise attended the program of walking on a treadmill machine for eight weeks according to specific parameters, in addition to their usual daily calcium intake.

Procedure: aerobic exerciseProcedure: resistance exercise

Group (B)

ACTIVE COMPARATOR

25 patients receive resisted exercise in addition to their usual daily calcium intake for 12 weeks.

Procedure: aerobic exerciseProcedure: resistance exercise

Interventions

aerobic exercise. * Intensity: according to heart rate (60-75% of maximum heart rate) MHR=220-age. * Heart rate: determined by the sensor of a treadmill. * Duration: 40-50 min per session. Each session consisted of 5-10 minutes of warming up exercise on a treadmill without increasing speed or intensity and the same for the cooling down phase. There was 30 minutes of conditioning exercise including increasing the treadmill speed till reaching (60-75%) of the maximum heart rate. * Frequency: 3 times/week for 12 weeks in addition to their usual daily calcium intake.

Group (A)Group (B)

resisted exercise program for 12 weeks

Group (A)Group (B)

Eligibility Criteria

Age50 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Fifty women postmenopausal obese women
  • (BMI) 30 -35 kg/m2
  • their age ranges from 50 to 60 years old and
  • complain of diabetic type 2 for 10 years ago.

You may not qualify if:

  • women with renal or liver disease,
  • cardiac or chest disease psychological problems,
  • cognitive problems are excluded from the study.
  • Any women who have therapeutic problems that will interfere with performing exercise or affection BMD will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soad A. Mohamad

Minya, 05673, Egypt

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind masking the patient was not be informed about the training group or the other group; they will be evaluated and trained at different places and times.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 17, 2024

Study Start

March 10, 2024

Primary Completion

June 22, 2024

Study Completion

August 1, 2024

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations