Buerger's Exercises and Proprioceptive Drills on Postural Stability and Foot Perfusion in Elderly Patients With Chemotherapy
Combined Effect of Buerger's Exercises and Proprioceptive Drills on Postural Stability and Foot Perfusion in Elderly Patients With Chemotherapy-Induced Peripheral Neuropathy Randomized Controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting side effect of neurotoxic chemotherapy agents, characterized by sensory loss, impaired proprioception, and muscle weakness, predominantly affecting the lower limbs. These impairments significantly contribute to postural instability and increase fall risk in elderly patients. Additionally, CIPN-associated microvascular changes can compromise peripheral circulation, further exacerbating neuromotor dysfunction and balance deficits.
While pharmacological options for CIPN are limited and often inadequate, exercise-based interventions have shown promise in mitigating functional impairments. Buerger's exercises, a vascular stimulation technique, are known to enhance peripheral blood flow, whereas proprioceptive drills can improve neuromuscular coordination and postural control. However, their combined effect on both postural stability and foot perfusion in elderly patients with CIPN has not been systematically studied.
Study Overview
Status
Intervention / Treatment
Detailed Description
Aim of the Study To investigate the combined effect of Buerger's exercises and proprioceptive drills on postural stability and foot perfusion in elderly patients with chemotherapy-induced peripheral neuropathy.
Objectives
Primary Objectives:
- To evaluate the effect of combined Buerger's exercises and proprioceptive drills on postural stability.
- To assess their effect on foot perfusion.
Secondary Objectives:
• To assess changes in balance confidence, functional mobility, and fall incidence.
________________________________________
Hypotheses
- H1: The combined intervention will significantly improve postural stability compared to standard care.
- H2: The combined intervention will significantly enhance foot perfusion compared to standard care.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: ibrahim abuzaid, Assistant professor
- Phone Number: 01006512160
- Email: ibrahim_ismail_2011@svu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years or older
- Diagnosed with CIPN for at least 3 months
- Demonstrating impaired postural stability (BBS ≤ 48 or ≥2 falls in the past year)
- Medically cleared for exercise
- Cognitively intact (MMSE ≥ 24)
- Willing and able to give consent
Exclusion Criteria:
- Severe peripheral arterial disease (ABI < 0.5)
- Severe postural hypotension or positional syncope
- Recent orthopedic procedures or fractures (past 6 months)
- Vestibular or cerebellar disorders
- Uncontrolled systemic diseases
- Cognitive impairment (MMSE < 24)
- Concurrent participation in another structured balance or vascular program
- Lower limb ulcers or active infection
- Severe visual impairment
- Intolerance to positional exercises
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Intervention Group (35 participants) will receive Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
|
Active Comparator: Control Group
Control Group (35 participants) will receive Standard care with educational leaflets and physical activity advice.
|
Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Stability Foot Perfusion
Time Frame: Week 8
|
.Postural Stability: Overall Stability Index (OSI) via Biodex Balance System SD Foot Perfusion: Laser Doppler Flowmetry (LDF)
|
Week 8
|
|
Pain scale (VAS) Quality of Life Index (QLI) - SCI Version
Time Frame: 8 weeks
|
Pain scale (VAS) The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Quality of Life Index (QLI) - SCI Version Comprised of 4 domains:
|
8 weeks
|
|
Weight Height Body mass index
Time Frame: 8 weeks
|
Weight in kg, height in meter and body mass index in kg/m2
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcomes
Time Frame: 8 weeks
|
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chang CF, Chang CC, Hwang SL, Chen MY. Effects of Buerger Exercise Combined Health-Promoting Program on Peripheral Neurovasculopathy Among Community Residents at High Risk for Diabetic Foot Ulceration. Worldviews Evid Based Nurs. 2015 Jun;12(3):145-53. doi: 10.1111/wvn.12091. Epub 2015 May 11.
- Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.
Helpful Links
- Background: Peripheral neuropathy and vasculopathy are important risk factors for diabetic foot ulceration (DFU). Buerger exercises for patients with arterial occlusive disease have previously been noted; however, current evidence to support this interve
- Aim: Buerger-Allen exercise includes set of activities like elevation, movement and rest of the lower extremities. This systematic review and meta-analysis aimed to assess the effectiveness of BAE on foot perfusion among patient with diabetes mellitus.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Qena university
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.