Effect of Progressive Loading Protocol on Bone Mineral Density

NCT ID: NCT05889104

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-08-05

Brief Summary

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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.

Detailed Description

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Progressive Loading Protocol (PLP): The subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week for the duration of 6 weeks. The PLP is adapted and modified based on Exercise and Sports Science Australia (ESSA) position statement on exercise prescription for the prevention and management of Osteoporosis. The participants in the progressive loading group will perform vertical and multidirectional jumping, bounding, hopping, skipping rope, drop jumps and bench stepping. The weight bearing intensity will be progressed by increasing heights for activities such as bounding and drop jumping, adding weighted vests and changing directions. To prevent the risk of injury, the participants would be instructed to avoid the loaded spine flexion or twisting movements of the spine. Frail individuals should be supervised and exercised within reach of a railing or other stable support.

Intensity: Moderate-to-high weight bearing impact loads (\>2 times body weight) that are progressive, novel, and multidirectional, within the limits of pain, increasing as tolerated.

Frequency: 4-7 days per week

Sets/Repetitions: Aim to work up to 50 repetitions over time (5 sets of 10 repetitions with 1-2 min rest between sets)

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

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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The Progressive Loading Group (PLG)

using Progressive Loading protocol.

Group Type EXPERIMENTAL

Progressive Loading Protocol (PLP):

Intervention Type OTHER

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

TheControl Group (CG)

using a randomization program

Group Type OTHER

Randomization Program

Intervention Type OTHER

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

Interventions

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Randomization Program

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

Intervention Type OTHER

Progressive Loading Protocol (PLP):

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject with history of diabetes, hypertension

Exclusion Criteria

* 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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Saeed Mufleh

Senior Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SAEED MUFLEH ALNASSER, MSc

Role: STUDY_CHAIR

Armed Forces Hospital

Locations

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Armed Forces Hospital

Khamis Mushait, 'Asir Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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PLP on Bone Mineral in OR Pt.

Identifier Type: -

Identifier Source: org_study_id

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