Clinical trial NCT05889104: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Quality of life
Bone Mineral
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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..

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.

Primary outcomes:
measure: Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention
timeFrame: At the start of the intervention, then the measurement is done again after six weeks..
Secondary outcomes:
Other outcomes:
Locations:
city: Khamis Mushait
country: Saudi Arabia
facility: Armed Forces Hospital
state: Asir Region
Study officials:
affiliation: Armed Forces Hospital
name: SAEED MUFLEH ALNASSER, MSc
role: STUDY_CHAIR
References: