Chronic Low Back PainNCT07178561
Physical Activity and Exercise for Disability and Improving Mental Health in Elderly With Chronic Low Back Pain
A study testing Exercises for lower back, Exercises and Physical Activity Program and Advices in people with Chronic Low Back Pain, run by Al-Azhar University at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exercises for lower back, Exercises and Physical Activity Program and Advices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 10 Sep 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 60 years or older.
- 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.
- Mild to moderate symptoms of anxiety or depression, defined as a Hospital Anxiety and Depression Scale (HADS) score >7.
- Ability to walk independently or with minimal assistance, allowing participation in treadmill or cycling exercises.
Who cannot join
- Severe Mental Health Issues: Severe anxiety or depression (HADS score >15) or any other major psychiatric disorder.
- Acute or Unstable Medical Conditions: Including recent cardiovascular events (e.g., myocardial infarction, unstable angina), uncontrolled hypertension, or severe respiratory disease.
- Severe Musculoskeletal Disorders: Conditions that prevent safe participation in exercise, such as recent fractures, severe osteoporosis with risk of fracture, or advanced spinal pathology.
- Neurological Disorders: Significant neurological impairments affecting balance or mobility (e.g., stroke, Parkinson's disease, severe peripheral neuropathy).
- Recent Spine Surgery: Lumbar or spinal surgery within the past 6 months.
- Cognitive Impairment: Inability to understand instructions or provide informed consent.
- Participation in structured exercise programs in the past 3 months that could confound results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories1 site, 1 recruiting
- Recruiting
Naser Medical Complex _ Al shifa
Gaza, Gaza Strip
Osama N lecturer, Masrer, 00972599692702, osamashana20@gmail.com
About this study
Official title: The Effect of Physical Activity Program Along With Exercises on Disability Level and Mental Health Among the Elderly Population With Chronic Low Back Pain. Give me Breif Title
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.
Read more
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
- Being tested
- Exercises for lower back, Exercises and Physical Activity Program, Advices
- Keywords
- chronic low back pain, Elderly, sleep, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises for lower backOther
- 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.
- Exercise Program (30-40 minutes per session, 3 times/week):
- Lumbar Stabilization Exercises:
- Core Strengthening Exercises:
Exercises and Physical Activity ProgramOther
- 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")
- 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
- Main Activity
- 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
- Stationary Bicycle: Duration: 10-15 minutes Resistance: Low to moderate (enough to feel effort but no pain)
- Cool-Down (5 minutes): Slow treadmill walking or easy pedaling on the bike Gentle stretches: hamstrings, hip flexors, lumbar rotation
- Progression: based on patient tolerance Gradually in
AdvicesOther
Advices
| Study group | Role | What they receive |
|---|---|---|
| Group receive Exercises | Experimental | 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: Receives: Other: Exercises for lower back |
| Group receive Exercise and Physical Activity program | Experimental | Not described Receives: Other: Exercises and Physical Activity Program |
| control | Other | control group (advices) Receives: Other: Advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
mental health
Hospital Anxiety and Depression Scale (HADS) Symptoms of anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale (HADS), a reliable and widely used instrument for assessing psychological distress in clinical and community populations. The HADS consists of 14 items, with 7 items measuring anxiety (HADS-A) and 7 measuring depression (HADS-D). Each item is scored from 0 to 3, resulting in subscale scores ranging from 0 to 21, with higher scores indicating more severe symptoms. The HADS is particularly suitable for elderly populations because it focuses on psychological symptoms rather than somatic complaints that could overlap with chronic physical conditions. In this study, changes in HADS scores provided insight into the impact of the interventions on mental health, helping to determine whether combining physical activity with structured exercises could alleviate anxiety and depressive symptoms associated with chronic low back pain.
Measured: pre, 8 weeks post physiotherapy sessions and 8 weeks follow up
Disability
Oswestry Disability Index (ODI) Functional disability related to chronic low back pain was measured using the Oswestry Disability Index (ODI), a validated questionnaire that assesses the impact of back pain on daily activities and overall functional ability. The ODI includes 10 sections covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored from 0 to 5, with the total score expressed as a percentage, where higher percentages indicate greater disability. The ODI is widely recognized as a gold standard for evaluating the severity of functional impairment in individuals with low back pain. In the present study, reductions in ODI scores following the interventions were used to quantify improvements in participants' physical function and independence, reflecting the effectiveness of both the structured exercise program and the additional physical activity regimen.
Measured: pre, 8 weeks of physiotherapy session's and 8 weeks follow up
Sleep quality
Pittsburgh Sleep Quality Index (PSQI) Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a widely validated self-report questionnaire designed to measure sleep disturbances and overall sleep quality over the past month. The PSQI evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating poorer sleep quality, and the global score ranges from 0 to 21. In this study, the PSQI was used to examine changes in sleep patterns and disturbances in elderly participants with chronic low back pain. Improvements in sleep quality were expected to reflect the effectiveness of the intervention in reducing pain-related sleep disruptions and enhancing overall mental and physical well-being.
Measured: pre Physiotherapy interventions, 8 weeks post and 8 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Sep 2025
- Primary completion1 Jul 2026
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab ALdabbas, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178561
- Sponsor's protocol ID
- Al-Azhar UNIVERSITY in GAZA PA
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physical Activity Program Along With Exercises on Disability Level and Mental Health Among the Elderly Population With Chronic Low Back Pain. Give me Breif Title
- ClinicalTrials.gov ID
- NCT07178561
- Acronym / sponsor ID
- Al-Azhar UNIVERSITY in GAZA PA
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic low back pain, Elderly, sleep, mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group receive Exercises | Experimental | Other: Exercises for lower backExercise 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 receive Exercise and Physical Activity program | Experimental | Other: Exercises and Physical Activity Program |
| control | Other | Other: Advicescontrol group (advices) |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 60 years or older.
- 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.
- Mild to moderate symptoms of anxiety or depression, defined as a Hospital Anxiety and Depression Scale (HADS) score >7.
- Ability to walk independently or with minimal assistance, allowing participation in treadmill or cycling exercises.
Key exclusion criteria (7 listed)
- Severe Mental Health Issues: Severe anxiety or depression (HADS score >15) or any other major psychiatric disorder.
- Acute or Unstable Medical Conditions: Including recent cardiovascular events (e.g., myocardial infarction, unstable angina), uncontrolled hypertension, or severe respiratory disease.
- Severe Musculoskeletal Disorders: Conditions that prevent safe participation in exercise, such as recent fractures, severe osteoporosis with risk of fracture, or advanced spinal pathology.
- Neurological Disorders: Significant neurological impairments affecting balance or mobility (e.g., stroke, Parkinson's disease, severe peripheral neuropathy).
- Recent Spine Surgery: Lumbar or spinal surgery within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercises for lower back1. 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: | Other | Group receive Exercises |
| Exercises and Physical Activity Program1. 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 | Other | Group receive Exercise and Physical Activity program |
| AdvicesAdvices | Other | control |
Primary outcome
mental health
Time frame: pre, 8 weeks post physiotherapy sessions and 8 weeks follow up
Hospital Anxiety and Depression Scale (HADS) Symptoms of anxiety and depression were evaluated using the Hospital Anxiety and Depression Scale (HADS), a reliable and widely used instrument for assessing psychological distress in clinical and community populations. The HADS consists of 14 items, with 7 items measuring anxiety (HADS-A) and 7 measuring depression (HADS-D). Each item is scored from 0 to 3, resulting in subscale scores ranging from 0 to 21, with higher scores indicating more severe symptoms. The HADS is particularly suitable for elderly populations because it focuses on psychological symptoms rather than somatic complaints that could overlap with chronic physical conditions. In this study, changes in HADS scores provided insight into the impact of the interventions on mental health, helping to determine whether combining physical activity with structured exercises could alleviate anxiety and depressive symptoms associated with chronic low back pain.
Disability
Time frame: pre, 8 weeks of physiotherapy session's and 8 weeks follow up
Oswestry Disability Index (ODI) Functional disability related to chronic low back pain was measured using the Oswestry Disability Index (ODI), a validated questionnaire that assesses the impact of back pain on daily activities and overall functional ability. The ODI includes 10 sections covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored from 0 to 5, with the total score expressed as a percentage, where higher percentages indicate greater disability. The ODI is widely recognized as a gold standard for evaluating the severity of functional impairment in individuals with low back pain. In the present study, reductions in ODI scores following the interventions were used to quantify improvements in participants' physical function and independence, reflecting the effectiveness of both the structured exercise program and the additional physical activity regimen.
Sleep quality
Time frame: pre Physiotherapy interventions, 8 weeks post and 8 follow up
Pittsburgh Sleep Quality Index (PSQI) Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a widely validated self-report questionnaire designed to measure sleep disturbances and overall sleep quality over the past month. The PSQI evaluates seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, with higher scores indicating poorer sleep quality, and the global score ranges from 0 to 21. In this study, the PSQI was used to examine changes in sleep patterns and disturbances in elderly participants with chronic low back pain. Improvements in sleep quality were expected to reflect the effectiveness of the intervention in reducing pain-related sleep disruptions and enhancing overall mental and physical well-being.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises for lower back, Exercises and Physical Activity Program and Advices in people with Chronic Low Back Pain, run by Al-Azhar University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mosab Aldabbas Aldabbas M, PHD (00972597451222, mosab.m.aldabbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mental health (time frame: pre, 8 weeks post physiotherapy sessions and 8 weeks follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.