跳至主要内容
临床试验/NCT06791954
NCT06791954已完成不适用

The Efficacy of a Telerehabilitation Pilates Program on Lumbopelvic Muscle Morphology in Patients With Fibromyalgia Syndrome

Necmettin Erbakan University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Fibromyalgia Impact Questionnaire

研究概览

简要总结

The study aims to evaluate the effects of a telerehabilitation-based clinical pilates program in patients with fibromyalgia syndrome. A randomized controlled trial was designed. An online clinical Pilates-based exercise program targeting stability and strength that was conducted for 8 weeks with 2 sessions per week was developed for the telerehabilitation group. The same exercise programs for the control group were provided in brochures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Diagnosis of FMS at least one year before the study
  • •Stable general health condition for the past 6 months

排除标准

  • •Inability to cooperate with measurements
  • •Regular engagement in exercise

研究组 & 干预措施

Telerehabilitation group

Active Comparator

Telerehabilitation group

干预措施: Exercise (Other)

Control group

Other

Control group

干预措施: Exercise (Other)

Healthy Control Group

No Intervention

The first results were compared

结局指标

主要结局

Fibromyalgia Impact Questionnaire

时间窗: First day (at beginning) and last day (8. weeks)

The Fibromyalgia Impact Questionnaire (FIQ) is a measure consisting of 10 items that assess physical function, work status, productivity level, depression, anxiety, sleep, pain, stiffness, fatigue, and overall well-being. Higher scores indicate higher disease activity.

Central Sensitization Inventory Short-Form

时间窗: First day (at beginning) and last day (8. weeks)

Central Sensitization Inventory Short Form (CSI-SF) is designed to assess the presence of central sensitization and associated symptoms. The total score ranges from 0 to 36, with higher scores indicating greater severity of central sensitization.

Hospital Anxiety and Depression Scale

时间窗: First day (at beginning) and last day (8. weeks)

The Hospital Anxiety and Depression Scale comprises 14 items. Odd-numbered items assess anxiety, while even-numbered items evaluate depression. The lowest possible score for each subscale is 0, and the highest is 21.

Numeric Rating Scale

时间窗: First day (at beginning) and last day (8. weeks)

The Pain Numeric Rating Scale is a numerical version of the visual analog scale, where patients are asked to indicate the number that best reflects their pain severity on a scale from 0 to 10.

Ultrasonographic assessment

时间窗: First day (at beginning) and last day (8. weeks)

A 9 MHz linear probe was utilized to determine the transversus abdominis, external oblique, and internal oblique muscles. For the ultrasonographic evaluation of the lumbar multifidus muscles, subjects were positioned in supine and prone positions. A 1.5-6 MHz convex probe was initially placed in a transverse orientation to cover the L4-L5-S1 anatomical region.

McGill core endurance tests

时间窗: First day (at beginning) and last day (8. weeks)

The lumbopelvic stability was conducted using McGill core endurance tests, which included tests for trunk flexion, extension, and right and left lateral flexion endurance.

Fatigue Severity Scale

时间窗: First day (at beginning) and last day (8. weeks)

Fatigue Severity Scale (FSS) consists of a total of nine items. Each item is scored on a scale from 1 to 7. An increase in the total score indicates a higher level of fatigue severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

YASEMİN MİRZA

Research Assistant

Necmettin Erbakan University

研究点 (1)

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