NCT07178561

Physical Activity and Exercise for Disability and Improving Mental Health in Elderly With Chronic Low Back Pain

Not yet recruiting NA Last updated 17 September 2025

What this trial tests

NA trial testing Exercises for lower back in Chronic Low Back Pain in 100 participants. Not yet recruiting.

Timeline

10 September 2025

Primary endpoint
1 July 2026

1 August 2026

Quick facts

Lead sponsor	Al-Azhar University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	10 September 2025
Primary completion	1 July 2026
Estimated completion	1 August 2026

Drugs / interventions tested

• Exercises for lower back
• Exercises and Physical Activity Program
• Advices

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →

Sponsor

Al-Azhar University

Who can join

Adults 55 to 70, any sex, with Chronic Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study evaluated the effects of a combined physical activity and structured exercise program on disability and mental health in elderly individuals suffering from chronic low back pain. Chronic low back pain is highly prevalent among older adults and is often associated not only with functional limitations and disability but also with psychological issues such as anxiety, depression, and poor sleep quality. Addressing both physical and mental health aspects is essential to improve overall well-being and quality of life in this population.

Participants in the study will be randomly assigned to one of three groups. The Exercise + Physical Activity Program Group received a structured exercise regimen specifically designed to improve core strength, flexibility, balance, and overall mobility. In addition to the exercise sessions, participants were provided with a tailored physical activity program aimed at promoting daily movement, reducing sedentary behavior, and enhancing functional capacity in their everyday life.

The Exercise-Only Group followed the same structured exercise regimen but did not receive the additional physical activity component, allowing for comparison of the effects of exercise alone versus combined interventions.

The Control Group continued with usual care, which included standard advice for managing low back pain but no structured exercise or physical activity intervention, serving as a baseline to evaluate the effectiveness of the other interventions.

Outcomes were assessed in terms of disability levels, measured using validated scales, as well as mental health parameters, including symptoms of depression, anxiety, and sleep quality. Post-intervention results indicated that participants in the combined exercise and physical activity group experienced the most significant improvements in functional ability, as reflected by reduced disability scores. This group also showed the largest reductions in symptoms of anxiety and depression and improvements in sleep quality. The exercise-only group demonstrated moderate improvements, highlighting the benefits of structured exercise alone, while the control group showed minimal changes in either physical function or mental health outcomes.

Measurements will be taken pre , post (8 weeks of PT interventions) and 8 weeks follow up

These findings emphasize the added value of integrating general physical activity into structured exercise programs. Incorporating daily movement and functional activity beyond formal exercise sessions appears to enhance both physical and psychological outcomes in elderly individuals with chronic low back pain. The study underscores the importance of a comprehensive approach in the management of chronic musculoskeletal pain in older adults, combining targeted exercise with strategies to increase overall daily activity levels.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.