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Effect of Progressive Loading Protocol on Bone Mineral Density

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Randomization Program
Progressive Loading Protocol (PLP):
Sponsored by
Imam Abdulrahman Bin Faisal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Osteoporosis focused on measuring Quality of life, Bone Mineral

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Armed Forces Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

The Progressive Loading Group (PLG)

TheControl Group (CG)

Arm Description

using Progressive Loading protocol.

using a randomization program

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2023
Last Updated
September 27, 2023
Sponsor
Imam Abdulrahman Bin Faisal University
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1. Study Identification

Unique Protocol Identification Number
NCT05889104
Brief Title
Effect of Progressive Loading Protocol on Bone Mineral Density
Official Title
The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Abdulrahman Bin Faisal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Quality of life, Bone Mineral

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Progressive Loading Group (PLG)
Arm Type
Experimental
Arm Description
using Progressive Loading protocol.
Arm Title
TheControl Group (CG)
Arm Type
Other
Arm Description
using a randomization program
Intervention Type
Other
Intervention Name(s)
Randomization Program
Intervention Description
The subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program
Intervention Type
Other
Intervention Name(s)
Progressive Loading Protocol (PLP):
Intervention Description
he subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week.
Primary Outcome Measure Information:
Title
Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention
Description
to measure bone mineral density (BMD) at the spine and hip region. and hip regio
Time Frame
At the start of the intervention, then the measurement is done again after six weeks..

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SAEED MUFLEH ALNASSER, MSc
Organizational Affiliation
Armed Forces Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Armed Forces Hospital
City
Khamis Mushait
State/Province
Asir Region
ZIP/Postal Code
62456
Country
Saudi Arabia

12. IPD Sharing Statement

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Effect of Progressive Loading Protocol on Bone Mineral Density

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