Comparison Of Resistance Training And Core Strengthening Exercises Vitamin D In Postmenopausal Women With Low Back Pain

April 17, 2024 updated by: Muhammad Naveed Babur, Superior University

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Azra Naheed Medical College, Superior University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Postmenopausal women aged 50-70 years.
  • Experiencing low back pain for at least 3 months.
  • Capable of engaging in light to moderate physical exercise.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Resistance Training and Core Strengthening Exercises Group
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.
Diagnostic test: Resistance Training and Core Strengthening Exercises Group
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.
Other: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation

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.
Diagnostic test: Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Month
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.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPT/Batch-Fall19/556

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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