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

NCT ID: NCT07178561

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2026-08-01

Brief Summary

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.

Conditions

Chronic Low Back Pain

Study Design

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

Study Groups

Group receive Exercises

Exercise and Physical Activity Program for Elderly with Chronic Low Back Pain

1. Physiotherapy Modalities (Preparation):

Hot Pack Therapy: Applied to the lumbar region for 10-15 minutes before exercises to reduce muscle stiffness and pain.

Interferential Therapy (IFT): Applied to the lower back for 10-15 minutes to decrease pain and improve circulation.

2. Exercise Program (30-40 minutes per session, 3 times/week):

A. Lumbar Stabilization Exercises

B. Core Strengthening Exercises:

Group Type: EXPERIMENTAL

Exercises for lower back

Intervention Type: OTHER

1. Physiotherapy Modalities (Preparation):

Hot Pack Therapy: Applied to the lumbar region for 10-15 minutes before exercises to reduce muscle stiffness and pain.

Interferential Therapy (IFT): Applied to the lower back for 10-15 minutes to decrease pain and improve circulation.

2. Exercise Program (30-40 minutes per session, 3 times/week):

A. Lumbar Stabilization Exercises:

B. Core Strengthening Exercises:

Group receive Exercise and Physical Activity program

Group Type: EXPERIMENTAL

Exercises and Physical Activity Program

Intervention Type: OTHER

1. Frequency & Duration:

Frequency: 3 days per week

Duration: 30 to 40minutes per session

Intensity: Low to moderate (RPE 11-13 on Borg scale; "light to somewhat hard")

2. Warm-Up (5 minutes):

Gentle walking on treadmill at slow speed (1.5-2.5 km/h)

Light dynamic stretches for lower back, hips, and legs

3. Main Activity

A. Treadmill Walking:

Speed: Comfortable pace for walking without pain

Incline: Start flat, increase slightly (1-2%) if tolerated

Goal: Promote cardiovascular endurance and safe weight-bearing activity

B. Stationary Bicycle:

Duration: 10-15 minutes

Resistance: Low to moderate (enough to feel effort but no pain)

4. Cool-Down (5 minutes):

Slow treadmill walking or easy pedaling on the bike

Gentle stretches: hamstrings, hip flexors, lumbar rotation

5. Progression:

based on patient tolerance Gradually in

control

control group (advices)

Group Type: OTHER

Advices

Intervention Type: OTHER

Advices

Interventions

Exercises for lower back

1. Physiotherapy Modalities (Preparation):

Hot Pack Therapy: Applied to the lumbar region for 10-15 minutes before exercises to reduce muscle stiffness and pain.

Interferential Therapy (IFT): Applied to the lower back for 10-15 minutes to decrease pain and improve circulation.

2. Exercise Program (30-40 minutes per session, 3 times/week):

A. Lumbar Stabilization Exercises:

B. Core Strengthening Exercises:

Intervention Type: OTHER

Exercises and Physical Activity Program

1. Frequency & Duration:

Frequency: 3 days per week

Duration: 30 to 40minutes per session

Intensity: Low to moderate (RPE 11-13 on Borg scale; "light to somewhat hard")

2. Warm-Up (5 minutes):

Gentle walking on treadmill at slow speed (1.5-2.5 km/h)

Light dynamic stretches for lower back, hips, and legs

3. Main Activity

A. Treadmill Walking:

Speed: Comfortable pace for walking without pain

Incline: Start flat, increase slightly (1-2%) if tolerated

Goal: Promote cardiovascular endurance and safe weight-bearing activity

B. Stationary Bicycle:

Duration: 10-15 minutes

Resistance: Low to moderate (enough to feel effort but no pain)

4. Cool-Down (5 minutes):

Slow treadmill walking or easy pedaling on the bike

Gentle stretches: hamstrings, hip flexors, lumbar rotation

5. Progression:

based on patient tolerance Gradually in

Intervention Type: OTHER

Advices

Advices

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Age: 60 years or older.

2. Chronic Low Back Pain: History of low back pain lasting ≥12 weeks Poor sleep quality, defined as a Pittsburgh Sleep Quality Index (PSQI) score >5.

3. Mild to moderate symptoms of anxiety or depression, defined as a Hospital Anxiety and Depression Scale (HADS) score >7.

4. Ability to walk independently or with minimal assistance, allowing participation in treadmill or cycling exercises.

Exclusion Criteria

1. Severe Mental Health Issues: Severe anxiety or depression (HADS score >15) or any other major psychiatric disorder.

2. Acute or Unstable Medical Conditions: Including recent cardiovascular events (e.g., myocardial infarction, unstable angina), uncontrolled hypertension, or severe respiratory disease.

3. Severe Musculoskeletal Disorders: Conditions that prevent safe participation in exercise, such as recent fractures, severe osteoporosis with risk of fracture, or advanced spinal pathology.

4. Neurological Disorders: Significant neurological impairments affecting balance or mobility (e.g., stroke, Parkinson's disease, severe peripheral neuropathy).

5. Recent Spine Surgery: Lumbar or spinal surgery within the past 6 months.

6. Cognitive Impairment: Inability to understand instructions or provide informed consent.

7. Participation in structured exercise programs in the past 3 months that could confound results.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Mosab ALdabbas

Assistant professor at Al azhar university and field officer at ICRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mosab Aldabbas Aldabbas M, PHD

Role: CONTACT

mosab.m.aldabbas@gmail.com

00972597451222

Other Identifiers

Al-Azhar UNIVERSITY in GAZA PA

Identifier Type: -

Identifier Source: org_study_id