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

NCT ID: NCT06377618

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-06-20

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Resistance Training and Core Strengthening Exercises Group

Intervention Type: DIAGNOSTIC_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 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.

Group Type: OTHER

Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation

Intervention Type: DIAGNOSTIC_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

Interventions

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

DPT/Batch-Fall19/556

Identifier Type: -

Identifier Source: org_study_id