NCT Number: NCT07291934
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.
Trial opening soon.
Get Notified30 year–50 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
Effect of Pilates and Resistance Training on Pain, Disability, and Sleep Quality in Patients With Chronic Low Back Pain and Sleep Disturbances
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.
Published trials that share one or more normalized conditions with this study.
NCT07158567
Chronic Low Back Pain, Muscular Diseases
Chicago, Illinois, United States
View Trial DetailsNCT07053787
Chronic Low Back Pain
San Diego, California, United States
View Trial DetailsNCT07693517
Chronic Low Back Pain, Lumbar Spine Surgery
Caracas, Distrito Capitañ, Venezuela
View Trial DetailsNCT07639060
Arthritis, Autonomic Nervous System Diseases
View Trial Details