Effect of Progressive Loading Protocol on Bone Mineral Density

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05889104
Collaborator
(none)
50
2
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Randomization Program
  • Other: Progressive Loading Protocol (PLP):
N/A

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..

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.
Anticipated Study Start Date :
Jun 21, 2023
Anticipated Primary Completion Date :
Aug 21, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: The Progressive Loading Group (PLG)

using Progressive Loading protocol.

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.

Other: TheControl Group (CG)

using a randomization program

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

Outcome Measures

Primary Outcome Measures

  1. Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention [At the start of the intervention, then the measurement is done again after six weeks..]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Saeed Mufleh, Senior Physiotherapist, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier:
NCT05889104
Other Study ID Numbers:
  • PLP on Bone Mineral in OR Pt.
First Posted:
Jun 5, 2023
Last Update Posted:
Jun 5, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Saeed Mufleh, Senior Physiotherapist, Imam Abdulrahman Bin Faisal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 5, 2023