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

NCT06377618 | Active Not Recruiting DMC

• 1 other identifier: DPT/Batch-Fall19/556
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal; Pain, Low Back

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  6 Months

Study Arms (2)

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.

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.

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

Interventions

Resistance Training and Core Strengthening Exercises Group 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

Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation 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

Resistance Training and Core Strengthening Exercises Group Plus Vitamin D Supplementation

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: January 15, 2024
• Primary Completion: May 20, 2024
• Study Completion: June 20, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

PA (1)