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

NCT07137078 | Completed

• 1 other identifier: P.T.REC/012/005944
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathy

Outcome Measures

Primary Outcomes (1)

• Chemotherapy Induced Peripheral Neuropathy Assessment Tool

  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.

  at baseline and at 12 weeks

Secondary Outcomes (3)

• 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

Study Arms (3)

(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.

Other: pilates

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

Other: gyrotonic expansion exercise

control

NO INTERVENTION

No traninig

Interventions

pilates 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.

(Pilates exercise

gyrotonic expansion exercise 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

gyrotonic expansion exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

faculty of physical therapy ,Cairo University

Cairo, 3753450, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor

Model Details: RCT

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 5, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

EG (1)