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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.
• Другое 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.

Первичные конечные точки

• Pain Intensity: [Срок оценки: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]
• Disability [Срок оценки: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]
• Sleep_ Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Assessment Time Points: Baseline (pre-intervention) Post-intervention (8 weeks) Follow-up (16 weeks)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07291934 · ALAZHAR UNIVERSITY in Gaza

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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