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

NCT07291934 | Not Yet Recruiting DMC

• 1 other identifier: ALAZHAR UNIVERSITY in Gaza
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Low Back Pain

Keywords

sleep; chronic low back pain; disability; Pilate; Resistance traning

Outcome Measures

Primary Outcomes (3)

• Pain Intensity:

  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

  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)

  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)

Study Arms (3)

Combined Intervention Group (Pilates + Resistance Training):

EXPERIMENTAL

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)

Pilates Group

EXPERIMENTAL

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

Control Group (Usual Care):

OTHER

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)

Interventions

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.

Pilates Group

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.

Control Group (Usual Care):

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.

Combined Intervention Group (Pilates + Resistance Training):

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Interventions

Resistance Training; Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Mosab M Aldabbas, PhD

CONTACT

00972597451222; mosab.m.aldabbas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR AT AL AZHAR UNIVERSITY

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 18, 2025
• Study Start: January 25, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share