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临床试验/NCT07137078
NCT07137078已完成不适用

Pilates Versus Gyrotonic Expansion System on Chemotherapy Induced Peripheral Neuropathy and Fall Risk

MTI University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年10月1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
100
试验地点
1
主要终点
Chemotherapy Induced Peripheral Neuropathy Assessment Tool

研究概览

简要总结

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting side effect of neurotoxic chemotherapy (ie, taxanes, vinca alkaloids, platinum, and bortezomib) that interferes with patients' daily function and worsens quality of life (1-3). In a study of 512 cancer survivors, 47% reported persistent neuropathy up to 6 years after chemotherapy completion. Furthermore, these survivors exhibited altered gait patterns with slower and shorter steps, as well as a fall risk 1.8-fold greater than that of those without CIPN (4). In another study, 12% of cancer survivors with CIPN reported falls within a 3-month period (5). These evidences highlight the need for an effective treatment for CIPN to improve quality of life and safety among cancer survivors. Current empirical treatments for CIPN include symptom management with analgesics, antidepressants, and antiepileptics (6). However, these approaches are limited not only by toxicities but also by patients' reluctance to further medicate a medication-related condition.

详细描述

Pilates can be an effective intervention to address patients received chemotherapy and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.

Pilates can be an effective intervention to address chemotherapy-induced peripheral neuropathy (CIPN) and the associated increased risk of falls. CIPN is a common side effect of certain chemotherapy drugs, characterized by nerve damage that leads to symptoms such as pain, tingling, numbness, and weakness primarily in the hands and feet. These symptoms significantly impact balance and mobility, increasing the risk of falls. Pilates, with its focus on core strength, balance, flexibility, and controlled movement, can help mitigate these effects. The slow, deliberate movements in Pilates improve proprioception and strengthen the core and lower extremities, which are crucial for maintaining balance and stability. Regular Pilates practice can enhance postural alignment and muscle coordination, which can reduce the risk of falls in individuals experiencing CIPN.

The Gyrotonic Expansion System (GES) is an innovative movement methodology that is gaining attention for its potential benefits in addressing chemotherapy side effects, result in numbness, tingling, and pain in the extremities, significantly affecting balance and increasing fall risk. The GES involves fluid, spiraling movements designed to enhance flexibility, strength, coordination, and balance. By promoting increased circulation and nerve stimulation, these movements may help alleviate the symptoms of chemotherapy, potentially improving patient outcomes. The system's focus on core strength and alignment can also aid in stabilizing posture, thereby reducing the likelihood of falls.

研究设计

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

入排标准

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

入选标准

  • •Adults aged 18-65 years
  • •Diagnosed with CIPN
  • •Completed at least 3 cycles of chemotherapy
  • •Ability to provide informed consent

排除标准

  • •Severe neuropathy requiring pharmacological intervention
  • •Concurrent participation in another physical therapy regimen
  • •Any medical condition contraindicating physical exercise.

研究组 & 干预措施

(Pilates exercise

Experimental

Pilates exercises, particularly those focusing on core stability, balance, and flexibility, are highly beneficial for individuals at risk of falls. These exercises enhance proprioception, which is the body's ability to sense movement, action, and location, thereby improving coordination and balance. For example, exercises like the "Single Leg Stretch" and "Roll-Up" target the abdominal muscles, which are crucial for maintaining stability. Additionally, "Leg Circles" and "Side Planks" help strengthen hip abductors and stabilizers, contributing to better postural alignment and reducing the likelihood of falls. By regularly incorporating Pilates into a fitness routine, individuals can build strength and confidence, ultimately helping to prevent falls and maintain independence.

干预措施: pilates (Other)

gyrotonic expansion exercise

Experimental

Exercise phase Training Time Warm-Up Gentle, dynamic stretches focusing on the spine, hips, and legs. Gently roll the head from side to side to release tension, Move shoulders in a circular motion to loosen muscles, While standing, rotate the torso gently from side to side, Rotate each ankle in both directions to improve mobility. 5 minutes Core Activation Using pulley rope system the Arch and Curl, to engage the abdominal muscles, Focus on maintaining proper alignment and breathing deeply. 13 minutes Balance and Coordination Using pulley rope system Standing Series, shifting weight, such as the Spiral Sequence, to improve coordination. 12 minutes Flexibility and Range of Motion Leg stretches using the Leg Extension Unit to improve hip and knee range of motion. 5 minutes

干预措施: gyrotonic expansion exercise (Other)

control

No Intervention

No traninig

结局指标

主要结局

Chemotherapy Induced Peripheral Neuropathy Assessment Tool

时间窗: at baseline and at 12 weeks

The CIPNAT is a fifty item instrument that contains two sets of items symptom experience items and interference items. The 36 symptom experience items measure severity, distress, and frequency of nine neuropathic symptoms including; numbness in the hands, numbness in the feet, tingling in the hands, tingling in the feet, sensitivity to cold temperatures, nerve pain, muscle/joint aches, muscle weakness and loss of balance. Participants are first asked whether they have developed any of the nine symptoms since receiving chemotherapy. For each symptom reported, participants are asked to rate the intensity, distress, and frequency of that symptom on a 0-10 numeric rating scale. The symptom experience item set is scored by adding the number of symptoms reported (0-9) with the severity, distress, and frequency scores for each reported symptom. Scores range from 0-279 with higher scores corresponding with higher levels of CIPN.

次要结局

  • Grip Strength(at baseline and at 12 weeks)
  • Dynamic Balance(at baseline and at 12 weeks)
  • Dual Task (DT) Gait Speed(at baseline and at 12 weeks)

研究者

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

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

Assisstant professor

MTI University

研究点 (1)

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