Physical activity and exercise to help disability and mental health in older adults with chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial enrolled adults aged 60 and above with chronic low back pain and mild to moderate anxiety or depression, and randomly assigned them to one of three groups: a structured back-focused exercise program, a tailored physical activity program for daily movement, or a combination of both. The primary goal is to see if physical activity and targeted exercise can lessen disability and improve mental health and sleep quality. Participants were allowed to walk or bike with supervision, and safety exclusions were applied for severe medical or psychiatric conditions. Results from similar approaches in the past have shown promise in reducing pain-related disability and improving well-being, though contexts vary. This study is conducted under a lead sponsor in Gaza with collaboration from Al-Azhar University.

Why it matters

Who can join: the full rules

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.

Where it's running

• Naser Medical Complex _ Al shifa
  Gaza, Gaza Strip, Palestinian Territories Recruiting

Study contacts

• Study coordinator: Mosab Aldabbas Aldabbas M, PHD
• Email: mosab.m.aldabbas@gmail.com
• Phone: 00972597451222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.