MenopausalNCT06377618
Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain
A study testing Resistance Training and Core Strengthening Exercises Group and Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation in people with Menopausal and Pain, Low Back, run by Superior University at 1 site in Pakistan.
Trial summary
This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Menopausal, Pain, Low Back
- What is being tested?
- Resistance Training and Core Strengthening Exercises Group and Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2024to 20 Jun 2024
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 50-70 years.
- Experiencing low back pain for at least 3 months.
- Capable of engaging in light to moderate physical exercise.
Who cannot join
- History of spinal surgery.
- currently taking vitamin D supplements.
- Diagnosed with severe osteoporosis.
- Chronic use of pain medication that cannot be temporarily ceased.
- Current participation in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
Official title: Comparison Of Resistance Training And Core Strengthening Exercises Along With Vitamin D Intake In Postmenopausal Women With Low Back Pain
This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women.
Read the detailed description
Postmenopausal women are particularly susceptible to LBP due to physiological changes such as reduced estrogen levels, decreased muscle mass, and bone density. The randomized controlled trial (RCT) will be conducted over six months in various clinical settings in Lahore, with a sample size of 36 participants, divided into two groups. The inclusion criteria focus on postmenopausal women aged 50-70 years experiencing LBP for at least three months and who are not currently taking vitamin D supplements. Data on pain intensity, functional disability, muscle strength, endurance, and vitamin D levels will be collected and analyzed to assess the interventions' impact. The study's findings could provide evidence-based recommendations for managing LBP in postmenopausal women, combining physical activity with nutritional supplementation.
- Conditions
- Menopausal, Pain, Low Back
- Being tested
- Resistance Training and Core Strengthening Exercises Group, Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training and Core Strengthening Exercises GroupDiagnostic test
The regimen includes resistance training (using bands, weights, and bodyweight for major muscle groups) and core strengthening (targeting abdominal, lower back, hip, and gluteal muscles) exercises.
Resistance Training and Core Strengthening Exercises Group Plus Vitamin D SupplementationDiagnostic test
Group 1 Intervention plus Vitamin D Supplementation: Daily vitamin D supplementation, with the dosage adjusted based on initial serum 25(OH)D levels to achieve and maintain optimal vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training and Core Strengthening Exercises Group | Experimental | The regimen includes resistance training (using bands, weights, and bodyweight for major muscle groups) and core strengthening (targeting abdominal, lower back, hip, and gluteal muscles) exercises. Receives: Diagnostic Test: Resistance Training and Core Strengthening Exercises Group |
| Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation | Other | Identical exercise protocol to Group 1, with three supervised sessions per week.
First Arm Intervention plus Vitamin D Supplementation: Daily vitamin D supplementation, with the dosage adjusted based on initial serum 25(OH)D levels to achieve and maintain optimal vitamin D status. Typical dosages range from 800 to 2000 IU/day, subject to adjustments as necessary.
Serum 25(OH)D levels and potential supplementation-related adverse effects will be monitored at baseline and after 12 weeks.
Outcome Measures: In addition to the same outcome measures as Group 1, changes in serum 25(OH)D levels will also be assessed. Receives: Diagnostic Test: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Measured: 6 Month
Oswestry Disability Index (ODI)
a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Jan 2024
- Primary completion20 May 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopausalStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377618
- Sponsor's protocol ID
- DPT/Batch-Fall19/556
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Resistance Training And Core Strengthening Exercises Along With Vitamin D Intake In Postmenopausal Women With Low Back Pain
- ClinicalTrials.gov ID
- NCT06377618
- Acronym / sponsor ID
- DPT/Batch-Fall19/556
- Conditions
- Menopausal, Pain, Low Back
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 22 Apr 2024 (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.
This study aims to evaluate the effectiveness of resistance training, core strengthening exercises, and vitamin D supplementation in reducing low back pain (LBP) among postmenopausal women.
Detailed description
Postmenopausal women are particularly susceptible to LBP due to physiological changes such as reduced estrogen levels, decreased muscle mass, and bone density. The randomized controlled trial (RCT) will be conducted over six months in various clinical settings in Lahore, with a sample size of 36 participants, divided into two groups. The inclusion criteria focus on postmenopausal women aged 50-70 years experiencing LBP for at least three months and who are not currently taking vitamin D supplements. Data on pain intensity, functional disability, muscle strength, endurance, and vitamin D levels will be collected and analyzed to assess the interventions' impact. The study's findings could provide evidence-based recommendations for managing LBP in postmenopausal women, combining physical activity with nutritional supplementation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Training and Core Strengthening Exercises Group | Experimental | Diagnostic Test: Resistance Training and Core Strengthening Exercises GroupThe regimen includes resistance training (using bands, weights, and bodyweight for major muscle groups) and core strengthening (targeting abdominal, lower back, hip, and gluteal muscles) exercises. |
| Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation | Other | Diagnostic Test: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D SupplementationIdentical exercise protocol to Group 1, with three supervised sessions per week. First Arm Intervention plus Vitamin D Supplementation: Daily vitamin D supplementation, with the dosage adjusted based on initial serum 25(OH)D levels to achieve and maintain optimal vitamin D status. Typical dosages range from 800 to 2000 IU/day, subject to adjustments as necessary. Serum 25(OH)D levels and potential supplementation-related adverse effects will be monitored at baseline and after 12 weeks. Outcome Measures: In addition to the same outcome measures as Group 1, changes in serum 25(OH)D levels will also be assessed. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postmenopausal women aged 50-70 years.
- Experiencing low back pain for at least 3 months.
- Capable of engaging in light to moderate physical exercise.
Key exclusion criteria (5 listed)
- History of spinal surgery.
- currently taking vitamin D supplements.
- Diagnosed with severe osteoporosis.
- Chronic use of pain medication that cannot be temporarily ceased.
- Current participation in another clinical trial.
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 |
|---|---|---|
| Resistance Training and Core Strengthening Exercises GroupThe regimen includes resistance training (using bands, weights, and bodyweight for major muscle groups) and core strengthening (targeting abdominal, lower back, hip, and gluteal muscles) exercises. | Diagnostic test | Resistance Training and Core Strengthening Exercises Group |
| Resistance Training and Core Strengthening Exercises Group Plus Vitamin D SupplementationGroup 1 Intervention plus Vitamin D Supplementation: Daily vitamin D supplementation, with the dosage adjusted based on initial serum 25(OH)D levels to achieve and maintain optimal vitamin D | Diagnostic test | Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 6 Month
The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable
Oswestry Disability Index (ODI)
Time frame: 6 Months
a patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training and Core Strengthening Exercises Group and Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation in people with Menopausal and Pain, Low Back, run by Superior University at 1 site in Pakistan.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. 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 Pakistan. 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?
Results are not available in the source record.
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?
Visual Analog Scale (VAS) (time frame: 6 Month). The study lists 2 primary outcomes in all. 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 22 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.