Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain
NCT ID: NCT07291934
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
110 participants
INTERVENTIONAL
2026-01-25
2026-08-01
Brief Summary
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Combined intervention group: Pilates plus resistance training
Single intervention group: Pilates alone
Control group: Advices only
All interventions will be delivered 3 times per week for 8 weeks, with outcome measures assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). It is expected that the combined intervention group will show the greatest improvements in pain, disability, and sleep quality, while the single intervention group will demonstrate moderate benefits compared with usual care.
Detailed Description
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Combined Intervention Group: Pilates plus resistance training
Single Intervention Group: Pilates or resistance training alone
Control Group: Usual care
The intervention groups will participate in 2 supervised sessions per week for 8 weeks. The control group will continue their usual care without structured or supervisedexercise.
Outcome measures will be assessed at baseline, post-intervention (8 weeks), and follow-up (16 weeks). The outcomes include pain intensity and disability, while sleep quality.
The study aims to determine whether the combined exercise intervention produces greater improvements than a single exercise intervention or usual care, providing evidence for the most effective rehabilitation strategy for patients with chronic low back pain and sleep disturbances.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Combined Intervention Group (Pilates + Resistance Training):
Participants in this group will receive both Pilates and resistance training exercises. The program will be supervised 2 times per week for 8 weeks.This arm is designed to evaluate the synergistic effect of the combined interventions on pain, disability, and sleep quality.
Combined Intervention (Pilates + Resistance Training)
Participants will receive both Pilates and resistance training exercises, supervised 2 times per week for 8 weeks. This intervention aims to evaluate the combined effect on improving pain, disability, and sleep quality.
Pilates Group
Participants will perform Pilates exercises only under supervision 2 times per week for 8 weeks, with optional home practice. This arm will assess the effectiveness of Pilates alone on the study outcomes.
Pilates
Participants will perform Pilates exercises only, supervised 2 times per week for 8 weeks. This intervention will assess the effectiveness of Pilates alone on the study outcomes.
Control Group (Usual Care):
Participants in the control group will continue their routine care without structured or supervised exercise. This group will serve as a baseline comparison to determine the effects of the interventions beyond standard care.
Control (Usual Care)
Participants will continue their routine care without structured exercise. This intervention serves as a baseline comparison to determine the effects of the exercise programs beyond standard care.
Interventions
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Combined Intervention (Pilates + Resistance Training)
Participants will receive both Pilates and resistance training exercises, supervised 2 times per week for 8 weeks. This intervention aims to evaluate the combined effect on improving pain, disability, and sleep quality.
Pilates
Participants will perform Pilates exercises only, supervised 2 times per week for 8 weeks. This intervention will assess the effectiveness of Pilates alone on the study outcomes.
Control (Usual Care)
Participants will continue their routine care without structured exercise. This intervention serves as a baseline comparison to determine the effects of the exercise programs beyond standard care.
Eligibility Criteria
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Inclusion Criteria
* Sleep Quality: Poor sleep quality, defined as PSQI global score \>5.
Exclusion Criteria
* Recent spinal surgery: History of lumbar spine surgery within the past 12 months.
* Severe comorbidities: Serious cardiovascular, respiratory, neurological, or musculoskeletal disorders that contraindicate exercise.
* Pregnancy or planned pregnancy during the study period.
* Current participation in structured exercise programs targeting the back (Pilates, resistance training, or core stabilization) within the last 3 months.
* Use of sleep medications or interventions that cannot be maintained stable during the study period.
30 Years
50 Years
ALL
Yes
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Mosab ALdabbas
ASSISTANT PROFESSOR AT AL AZHAR UNIVERSITY
Central Contacts
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Other Identifiers
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ALAZHAR UNIVERSITY in Gaza
Identifier Type: -
Identifier Source: org_study_id