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

NCT ID: NCT07291934

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-25

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Chronic Low Back Pain

Keywords

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sleep chronic low back pain disability Pilate Resistance traning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Combined Intervention (Pilates + Resistance Training)

Intervention Type 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 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.

Group Type EXPERIMENTAL

Pilates

Intervention Type 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 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.

Group Type OTHER

Control (Usual Care)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mosab ALdabbas

ASSISTANT PROFESSOR AT AL AZHAR UNIVERSITY

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mosab M Aldabbas, PhD

Role: CONTACT

Phone: 00972597451222

Email: [email protected]

Other Identifiers

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ALAZHAR UNIVERSITY in Gaza

Identifier Type: -

Identifier Source: org_study_id