Effectiveness of a Therapeutic Physical Exercise Program During Outpatient Hospital Hemodialysis Treatment for the Improvement of Physical Capacity of Patients With Chronic Kidney Disease: A Randomized Controlled Multiple Cohort Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB)
研究概览
简要总结
Therapeutic Exercise During Outpatient Hemodialysis Treatment for Patients with Chronic Kidney Disease
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Treated for a minimum of 3 months with HD
- •With clinical stability (good tolerance to sessions expressed as stable vital signs during the session)
- •Voluntarily and with prior signed informed consent, have agreed to participate in the study
排除标准
- •Physical or cognitive limitations that prevent following the intervention program
- •Cardiovascular problems (unstable angina, uncontrolled arrhythmia, decompensated heart failure, pericarditis or myocarditis, severe untreated mitral or aortic stenosis)
- •Uncontrolled arterial hypertension (SBP > 200 mmHg and DBP > 120 mmHg)
- •Uncontrolled diabetes
- •Severe neuropathies
- •Acute systemic infection
- •Severe renal osteodystrophy
- •Stroke (cerebrovascular accident, transient ischemic attack)
研究组 & 干预措施
Control group
Therapeutic exercise intervention
This group recibe one intervention demonstrated by a physiotherapist about therapeutic exercise to apply during hemodialysis session
干预措施: Therapeutic exercise during hemodialysis session (Behavioral)
结局指标
主要结局
Short Physical Performance Battery (SPPB)
时间窗: Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3)
Physical capacity will be assessed using the Short Physical Performance Battery (SPPB) . The SPPB includes tests for balance, walking, and chair rise and sit. For the balance test, participants must stand in three positions: feet together, semi-tandem, and tandem. To earn 1 point and proceed to the semi-tandem position, they must remain with their feet together for at least 10 seconds. The same procedure applies for the tandem position. The walking test involves walking 4 meters at a comfortable pace, with the option of using assistive devices if necessary. The test is repeated twice, and the fastest time is selected. The scoring system is: 4 points for less than 4.82 seconds; 3 points for 4.48-6.20 seconds; 2 points for 6.21-8.70 seconds; 1 point for more than 8.70 seconds; and 0 points if the test is not completed. For the chair rise and sit test, participants must stand up and sit down 5 times as quickly as possible with arms crossed. The scoring is: 4 points for under 11.1
次要结局
- Barthel Index(Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3))
- Hospital Anxiety and Depression Scale (HADS)(Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3))
- Euro Quality of Life - EQ-5D-5L(Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3))
- HandGrip strength(Pre-intervention (A0) Post-intervention, after 16 weeks (A1) Up to 32 weeks (A2) Through study completion, an average of 1 year (A3))
研究者
Cristina Font
PhD in Comprehensive care and health services
University of Vic - Central University of Catalonia