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临床试验/NCT04148079
NCT04148079已完成不适用

Frequency of Arrhythmias During Physiotherapy

Universitatea de Medicina si Farmacie Iuliu Hatieganu0 个研究点目标入组 46 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
主要终点
Heart rate

研究概览

简要总结

This study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. The physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. What is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition.

详细描述

An analytical and transversal study was carried out between March 2013 and August 2017. The study included a total of 46 patients previously diagnosed with degenerative knee OA. All the patients included in the study were recruited during inpatient visit in the Clinical Rehabilitation Hospital in Cluj-Napoca, Romania.

Each patient was clinically evaluated and was furthermore prescribed a PT program (ET, massage and kinesiotherapy). They were monitored by 24 hour-Holter ECG in 2 separate days, at the beginning of treatment, before applying the PT methods (day 1), and after completing a 10-day PT program (day 2).

PT modalities prescribed for each patient after clinical evaluation included different types of ET, all currently used and included in the national and international treatment guidelines, as in low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy. The program was performed on a daily basis, for 10 days.

The aim of the PT program was to decrease pain and increase range of motion in the affected joints and did not lead to increases in cardiac frequencies. No hydrotherapy was applied, given that that the Holter ECG was not waterproof. No technical incidents were reported during the study. No alternate positioning of the patient wearing a Holter ECG for ET procedures was necessary, as the region of interest was the knee. No change in current drug therapy was allowed for the whole duration of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on ACR 2000 diagnostic criteria

排除标准

  • known cardiac arrhythmias (atrial fibrillation, atrial flutter)
  • congestive heart failure class NYHA II, III or IV
  • any other general contraindications for PT (infections, psychiatric disorders etc)

结局指标

主要结局

Heart rate

时间窗: Change from Baseline after 10 days

Minimal, average, maximum heart rate evaluated by 24 hour Holter EKG monitoring

Supraventricular, ventricular and total Extrasystoles

时间窗: Change from Baseline after 10 days

supraventricular, ventricular, total extraystoles evaluated by 24 hour Holter EKG monitoring

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ciubean Alina Deniza

Principal investigator

Universitatea de Medicina si Farmacie Iuliu Hatieganu

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