Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined Intervention (Pilates + Resistance Training), Pilates, Control (Usual Care).
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 30 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances
Overview
This study will investigate the effect of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances. Participants will be randomly assigned into three groups: 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
This study will investigate the effects of Pilates and resistance training on pain, disability, and sleep quality in patients with chronic low back pain and sleep disturbances in the Gaza Strip. The study will use a 3-arm randomized controlled trial design, with participants randomly assigned to one of three groups:
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.
Interventions
- Other 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. - Other 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. - Other 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.
Primary outcome measures
- Pain Intensity: [Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]
- Disability [Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]
- Sleep_ Pittsburgh Sleep Quality Index (PSQI) [Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]
Eligibility criteria
Inclusion criteria
- Clinically diagnosed with chronic low back pain (CLBP), defined as pain localized between the lower rib margin and gluteal folds, lasting ≥12 weeks.
- Sleep Quality: Poor sleep quality, defined as PSQI global score >5.
Exclusion criteria
- Specific LBP causes: Low back pain due to fractures, tumors, infections, inflammatory disorders, or systemic disease.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07291934 · ALAZHAR UNIVERSITY in Gaza