- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: ibrahim abuzaid, Assistant professor
- Telefonnummer: 01006512160
- E-Mail: ibrahim_ismail_2011@svu.edu.eg
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Aktiver 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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postural Stability Foot Perfusion
Zeitfenster: 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
Zeitfenster: 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:
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8 weeks
|
|
Weight Height Body mass index
Zeitfenster: 8 weeks
|
Weight in kg, height in meter and body mass index in kg/m2
|
8 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Secondary Outcomes
Zeitfenster: 8 weeks
|
|
8 weeks
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Qena university
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