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NCT Number: NCT07291934

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naser medical complex

Gaza, Palestinian Territories

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combined Intervention (Pilates + Resistance Training)

Other

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

Other

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)

Other

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 outcomes

  1. Pain Intensity:

    Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)

    Measured using the Visual Analog Scale (VAS), a 10-cm line where 0 indicates "no pain" and 10 indicates "worst imaginable pain." It captures the patient's perceived pain severity.

  2. Disability

    Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)

    Oswestry Disability Index (ODI)

    The Oswestry Disability Index (ODI) is a widely used, validated questionnaire that assesses functional disability in individuals with low back pain. It measures the impact of back pain on a person's ability to perform activities of daily living (ADL) and overall functional limitations.

    Structure:

    The ODI contains 10 sections, each focusing on a different aspect of daily function:

    Pain intensity

    Personal care (washing, dressing)

    Lifting

    Walking

    Sitting

    Standing

    Sleeping

    Social life

    Traveling

    Employment/homemaking

    Each section has 6 statements scored from 0 to 5, with higher scores indicating greater disability.

  3. Sleep_ Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)

    The Pittsburgh Sleep Quality Index (PSQI) is a validated, self-reported questionnaire used to assess sleep quality and disturbances over the past month. It is widely used in clinical and research settings, including studies on chronic pain and musculoskeletal disorders.

    Structure:

    The PSQI consists of 19 individual items combined into 7 components:

    Subjective sleep quality - the individual's perception of their sleep

    Sleep latency - time taken to fall asleep

    Sleep duration - total hours of sleep per night

    Habitual sleep efficiency - percentage of time in bed actually spent sleeping

    Sleep disturbances - factors causing sleep interruptions (e.g., waking up, pain, environmental disturbances)

    Use of sleep medication - frequency of taking sleep aids

    Daytime dysfunction - difficulty staying awake or maintaining function during the day

    Scoring:

    Each component is scored from 0 (no difficulty) to 3 (severe difficulty).

    The component scores are summed to generate a global PSQI score

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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