Evaluation of the Validity and Reliability of the '6 Minute Pegboard and Ring Test' Unsupported Arm Function Exercise Test in Patients Using Pacemakers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Evaluation of unsupported arm exercise capacity
研究概览
简要总结
Recently, the use of Cardiac Implantable Electronic Devices (CIED) is becoming widespread due to the improvement of patients' symptoms, reduction of sudden cardiac death and improved quality of life. Although implantation of the device is considered a minor invasive procedure, possible but often underestimated dysfunction of the same side upper extremity may develop after implantation. This increase in the number of device implantations makes shoulder dysfunction after pacemaker implantation a major health problem. In the current research in the literature, arm dysfunction is evaluated by measuring range of motion with a dynamic goniometer, scales scored independently of shoulder pathology and the effect of activities of daily living. This indicates that there is no objective functional assessment method used to evaluate arm function in CIED patients. Therefore, the point of this study is to find out how reliable and valid the 6 Minute Pegboard and Ring Test (6PBRT) is for testing the functional capacity of the upper extremity in people who have had CIED implanted.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18-65 who have a pacemaker,
- •At least 3 months have passed since pacemaker implantation and there are no complications in the last pacemaker control,
- •Being in NYHA class I-II-III,
- •Patients with no coordination problems,
- •Patients who volunteered to participate in the study.
排除标准
- •Patients with a history of shoulder pathologies prior to pacemaker implantation that may restrict movement of the upper limb (conditions such as severe pain around the shoulder, edema or shoulder dislocation that may restrict upper limb movement),
- •Patients with a history of shoulder surgery (limitation in range of motion),
- •Patients who have had a cerebrovascular event resulting in mastectomy or arm involvement on the affected side,
- •Patients with decompensated heart failure,
- •Patients with a history of ICD inappropriate shock,
- •Those with acute myocardial infarction,
- •Patients with malignancy on active treatment, collagen tissue disease receiving systemic steroids,
- •Chronic kidney disease patients on dialysis with unstable volume load.
研究组 & 干预措施
Cardiac Implantable Electronic Devices
individuals with cardiac implantable electronic devices
干预措施: validity and reliability study (Other)
结局指标
主要结局
Evaluation of unsupported arm exercise capacity
时间窗: 1 year
6 Minute Pegboard and Ring Test-6PBRT
Evaluation of maximal arm exercise capacity
时间窗: 1 year
Arm Ergometer Test / It is a gold standard method used to evaluate upper extremity exercise capacity. At the beginning and end of the test, heart rate, saturation and BORG scale will be evaluated for fatigue and dyspnea. In women, it will start with 20 watts and increase by 6 watts every 1 minute, while in men, it will start with 30 watts and increase by 10 watts every 1 minute. The rotation speed will be maintained at 70 rpm. The test will be terminated if the perceived exertion level is ≥ 18 and/or the rotation speed cannot be maintained above 60 rpm.
次要结局
- Evaluation of hand grip strength(1 year)
- Evaluation of Activities of Daily Living(1 year)
- Evaluation of Quality of Life(1 year)
- Evaluation of Kinesiophobia(1 year)
研究者
Gamze Nur AHISKALI
Physiotherapist Gamze Nur AHISKALI
Erol Olcok Corum Training and Research Hospital