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

December 5, 2025 updated by: Mosab ALdabbas, Al-Azhar University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Experimental: 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.
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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

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.
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)

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 25, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

December 5, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALAZHAR UNIVERSITY in Gaza

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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