Effect of Progressive Loading Protocol on Bone Mineral Density

Osteoporosis Clinical Trial

Official title:

The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05889104
• Other study ID #: PLP on Bone Mineral in OR Pt.
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: August 5, 2023

Study information

• Verified date: September 2023
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 5, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Saudi Arabia	Armed Forces Hospital	Khamis Mushait	Asir Region

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..