Pilates and Resistance Training for Pain, Disability, and Sleep in Chronic Low Back Pain

Al-Azhar University

Status: Not yet enrolling

Conditions: Chronic Low Back Pain

Treatments: Other: Control (Usual Care); Other: Combined Intervention (Pilates + Resistance Training); Other: Pilates

Study type: Interventional

Funder types: Other

Identifiers

NCT07291934

ALAZHAR UNIVERSITY in Gaza

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 3 patient groups

Combined Intervention Group (Pilates + Resistance Training):

Experimental group

Description:

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.

Treatment:

Other: Combined Intervention (Pilates + Resistance Training)

Pilates Group

Experimental group

Description:

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.

Treatment:

Other: Pilates

Control Group (Usual Care):

Other group

Description:

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.

Treatment:

Other: Control (Usual Care)