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

NCT ID: NCT07137078

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-01-05

Brief Summary

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.

Detailed Description

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.

Conditions

Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

(Pilates exercise

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.

Group Type: EXPERIMENTAL

pilates

Intervention Type: OTHER

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.

gyrotonic expansion exercise

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

Group Type: EXPERIMENTAL

gyrotonic expansion exercise

Intervention Type: OTHER

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

control

No traninig

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pilates

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.

Intervention Type: OTHER

gyrotonic expansion exercise

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

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

Assisstant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of physical therapy ,Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Ahmed M Elfahl, phd

Role: primary

nn_ee_mm_oo@yahoo.com

00201097782441 ext. m

Other Identifiers

P.T.REC/012/005944

Identifier Type: -

Identifier Source: org_study_id