Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Upper Limb Muscle Strength, triceps
研究概览
简要总结
The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. The intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. The second group (control group) will participate in the same program but without arm ergometer training.
The study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD confirmed by clinical examination and a pulmonary function test
- •Stable clinical condition (without recent respiratory system infections or any exacerbation of the disease)
- •Patients must be willing to re evaluate at the end of the study
- •Patients must be willing to give written consent for their participation in the study
排除标准
- •Age < 18 years old
- •Unstable cardiac disease
- •Musculoskeletal and neurological diseases that could affect exercise performance or preclude exercise
- •Patients of COPD final stage or other serious disease final stage
- •Significant cognitive or psychiatric impairment that would lead to an inability to follow simple commands in a group setting
结局指标
主要结局
Upper Limb Muscle Strength, triceps
时间窗: Change from Baseline Triceps Muscle Strength at 3 months
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, hand-grip
时间窗: Change from Baseline Handgrip Muscle Strength at 3 months
Assess via jamar hand dynamometer
Health-related Quality of Life, SGRQ
时间窗: Change from Baseline at 3 months
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Upper Limb Muscle Strength, biceps brachii
时间窗: Change from Baseline Biceps Brachii Muscle Strength at 3 months
Assess biceps brachii via hand-held dynamometer Micro FET2
Health-related Quality of Life, CAT
时间窗: Change from Baseline at 3 months
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Dyspnea, modified Borg Scale
时间窗: Change from Baseline Dyspnea at 3 months
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, mMRC Scale
时间窗: Change from Baseline Dyspnea at 3 months
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Fatigue
时间窗: Change from Baseline Fatigue at 3 months
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Activities of Daily Living with Upper Limbs
时间窗: Change from Baseline time at 3 months
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
次要结局
未报告次要终点
研究者
Christos Karagiannis
PhD candidate in Physiotherapy
European University Cyprus