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临床试验/NCT02493387
NCT02493387已完成不适用

Should Elderly Patients With Atrial Fibrillation be Offered Physiotherapist Group Exercise or Can Physical Activity on Prescription (PAP) be Used as an Alternative

Göteborg University1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
1
主要终点
Physical fitness

研究概览

简要总结

Atrial fibrillation is the most common arrhythmia, and physical activity and exercise are sometimes avoided due to symptoms such as palpitations, fatigue and anxiety. Physiotherapist-led group based exercise as part of cardiac rehabilitation is rare for this group of patients, the method physical activity on prescription is used to encourage the patient to increase their physical activity level in order to reduce the risk of premature morbidity and mortality. However, mostly in this method you do not know the patient's ability to perform the prescribed amount of physical activity, and its effect on physical fitness has not been studied in patients with heart disease, neither has the effect of physiotherapist led group-based exercise in patients with atrial fibrillation. The aim was to investigate the impact of physiotherapy led group-based exercise compared to physical activity on prescription in patients with atrial fibrillation regarding the level of physical fitness, physical activity, heart rate and health related quality of life (HR-QoL).

详细描述

Ninety consecutive patients aged 65-85 years, visiting the cardiology clinic at Alingsås Hospital, Sahlgrenska University Hospital and primary care in the western part of Sweden will be asked to participate in the study. Inclusion criteria are permanent atrial fibrillation verified with electrocardiogram (ECG), left ventricular ejection fraction (EF) ≥ 45% and no significant valvular lesions verified by ultrasound. Exclusion criteria: Coronary event or angina pectoris within 3 months prior to inclusion, stroke with residual symptoms, presence of pacemaker or not able to participate in functional tests due to other disabilities, or to read Swedish. Physical fitness will be measured by a symptom limited bicycle test and a muscle endurance test. Physical activity will be measured by accelerometer and the International Physical Activity Questionnaire (IPAQ),HR-QoL will be measured by Short form (SF-36).

After the tests and return of accelerometer the patients will be randomized either to physiotherapist led group-based exercise or motivated interviewing and physical activity on prescription (PAP). The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and two occasions of home-based exercise. The exercise program are designed after the patients requirements and with the intensity 13-17 on the Borg RPE 6-20 scale. The patients randomized to PAP will receive a PAP prescription and a physical activity diary. The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion. After three months all patients will perform the same tests as in baseline. A written informed consent will be obtained by the patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 85 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • permanent atrial fibrillation verified with electrocardiogram (ECG),
  • left ventricular ejection fraction (EF) ≥ 45% and
  • no significant valvular lesions verified by echocardiography

排除标准

  • Coronary event or angina pectoris within 3 months prior to inclusion,
  • stroke with residual symptoms,
  • presence of pacemaker or
  • not able to participate in functional tests due to other disabilities, or
  • to read Swedish.

研究组 & 干预措施

Exercise group

Experimental

The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and one or two occasions of home-based exercise. The exercise program are designed after the patients requirements and with the intensity 13-17 on the RPE 6-20 scale

干预措施: Exercise (Other)

PAP group

Active Comparator

The patients randomized PAP will receive a PAP prescription and a physical activity diary. The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion.

干预措施: Physical activity (Other)

结局指标

主要结局

Physical fitness

时间窗: 3 months

Working capacity in watt

次要结局

  • Physical activity(3 months)
  • Health related quality of life(3 months)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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