OsteoporosisNCT05889104
Effect of Progressive Loading Protocol on Bone Mineral Density
A study testing Randomization Program and Progressive Loading Protocol (PLP): in people with Osteoporosis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Randomization Program and Progressive Loading Protocol (PLP):
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2023to 5 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject with history of diabetes, hypertension
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Armed Forces Hospital
Khamis Mushait, 'Asir Region, 62456
About this study
Official title: The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.
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.
Read the 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..
- Conditions
- Osteoporosis
- Being tested
- Randomization Program, Progressive Loading Protocol (PLP):
- Keywords
- Quality of life, Bone Mineral
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomization ProgramOther
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):Other
he subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week.
| Study group | Role | What they receive |
|---|---|---|
| The Progressive Loading Group (PLG) | Experimental | using Progressive Loading protocol. Receives: Other: Progressive Loading Protocol (PLP): |
| TheControl Group (CG) | Other | using a randomization program Receives: Other: Randomization Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the start of the intervention, then the measurement is done again after six weeks..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Aug 2023
- Study completion5 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saeed Mufleh, Imam Abdulrahman Bin Faisal University
- Investigators
- SAEED MUFLEH ALNASSER, MSc, Study chair, Armed Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05889104
- Sponsor's protocol ID
- PLP on Bone Mineral in OR Pt.
- Status last verified
- Sep 2023
- First submitted
- 11 May 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.
- ClinicalTrials.gov ID
- NCT05889104
- Acronym / sponsor ID
- PLP on Bone Mineral in OR Pt.
- Conditions
- Osteoporosis
- Keywords
- Quality of life, Bone Mineral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 5 Aug 2023 (actual)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Progressive Loading Group (PLG) | Experimental | Other: Progressive Loading Protocol (PLP):using Progressive Loading protocol. |
| TheControl Group (CG) | Other | Other: Randomization Programusing a randomization program |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subject with history of diabetes, hypertension
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomization ProgramThe subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program | Other | TheControl Group (CG) |
| 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 | The Progressive Loading Group (PLG) |
Primary outcome
Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SAEED MUFLEH ALNASSER, MSc study chair
Armed Forces Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomization Program and Progressive Loading Protocol (PLP): in people with Osteoporosis, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention (time frame: At the start of the intervention, then the measurement is done again after six weeks..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.