NCT05889104

Brief Summary

The aims of this study are to examine the effects of Progressive Loading Exercises Protocol on Bone Mineral Density in osteoporotic patient's well-being and quality of life before a fracture occurs in order to create remedies. In addition, the available data from health research and clinical studies on osteoporosis will be evaluated for their impact on patient well-being and quality of life, providing an up-to-date and comprehensive overview of evidence-based treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

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

First Submitted

Initial submission to the registry

May 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2023

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

May 11, 2023

Last Update Submit

September 27, 2023

Conditions

Keywords

Quality of lifeBone Mineral

Outcome Measures

Primary Outcomes (1)

  • Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention

    to measure bone mineral density (BMD) at the spine and hip region. and hip regio

    At the start of the intervention, then the measurement is done again after six weeks..

Study Arms (2)

The Progressive Loading Group (PLG)

EXPERIMENTAL

using Progressive Loading protocol.

Other: Progressive Loading Protocol (PLP):

TheControl Group (CG)

OTHER

using a randomization program

Other: Randomization Program

Interventions

The subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program

TheControl Group (CG)

he subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week.

The Progressive Loading Group (PLG)

Eligibility Criteria

Age50 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject with history of diabetes, hypertension

You may not qualify if:

  • Subject with history of kidney diseases, cardiopulmonary diseases, thrombosis, hyperprolactinemia, spondylolisthesis, back/leg deformities or surgeries, osteoarthritis, pacemakers, implants of the lower extremity and spine, tumors, migraines, or having any other diseases that affect bone metabolism or neuromuscular performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Armed Forces Hospital

Khamis Mushait, 'Asir Region, 62456, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • SAEED MUFLEH ALNASSER, MSc

    Armed Forces Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physiotherapist

Study Record Dates

First Submitted

May 11, 2023

First Posted

June 5, 2023

Study Start

June 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 5, 2023

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations