- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07756073
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
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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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: ibrahim abuzaid, Assistant professor
- Telefonnummer: 01006512160
- E-mail: ibrahim_ismail_2011@svu.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Group
Intervention Group (35 participants) will receive Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
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Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
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Aktiv komparator: 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:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postural Stability Foot Perfusion
Tidsramme: Week 8
|
.Postural Stability: Overall Stability Index (OSI) via Biodex Balance System SD Foot Perfusion: Laser Doppler Flowmetry (LDF)
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Week 8
|
|
Pain scale (VAS) Quality of Life Index (QLI) - SCI Version
Tidsramme: 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
|
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Weight Height Body mass index
Tidsramme: 8 weeks
|
Weight in kg, height in meter and body mass index in kg/m2
|
8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Secondary Outcomes
Tidsramme: 8 weeks
|
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
Hjælpsomme 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Qena university
Plan for individuelle deltagerdata (IPD)
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