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

Menopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06377618
• Other study ID #: DPT/Batch-Fall19/556
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 20, 2024

Study information

• Verified date: April 2024
• Source: Superior University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Menopausal

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	Azra Naheed Medical College, Superior University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Superior University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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