跳至主要内容
临床试验/NCT05151666
NCT05151666撤回不适用

Assessing the Impact of Intra-dialytic Exercise Regimen on Depression Scores

NYU Langone Health4 个研究点 分布在 1 个国家开始时间: 2024年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
4
主要终点
Change in Beck Depression Inventory (BDI) Score

研究概览

简要总结

The purpose of the proposed clinical trial is to support intradialytic pedal cycling exercise as an intervention and show its effect on depression and how there is a need for more programs to support this. This is an exploratory single arm study. These patients will be cycling during dialysis treatment by using a graded duration model. Even though patients on hemodialysis (HD) have an increased life span due to renal replacement therapy, exercise can have a remarkable effect on their ability to perform daily activities. Dialysis has been shown to reduce self-confidence, increase social isolation, and cause feelings of disappointment in the future. This population faces mental and psychological stress due to the disease burden. Short-term supervised cycling programs while patients are receiving dialysis have been reported to induce systematic improvements for depression and anxiety. Exercise during hemodialysis is an effective way to reduce depressive symptoms without using pharmacologic measures.

Data for each patient will be collected at each dialysis treatment using a unique patient identifier. The data that will be collected include duration of exercise (intermittent or continuous), any complications during HD, vital signs while cycling every 30 minutes, and how they state they feel after cycling. The measurable outcome will be depression scores. The tool that will be used for this project is the Beck Depression Inventory (BDI). The patient will complete the BDI assessment on week 1 (pre intervention as baseline) and then on week 10 (post intervention).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • greater than 18 years of age
  • male or female
  • ESKD on maintenance hemodialysis for 3 consecutive months
  • adequate dialysis clearances (Kt/V greater than 1.2),
  • able to participate in exercise program based on nephrologist evaluation
  • able to provide written informed consent for participation,
  • Compliance with dialysis treatment regimen (attended 75% of ordered dialysis treatments in the last 3 months.

排除标准

  • less than 18 years old
  • on hemodialysis for < 3 consecutive months
  • acute Kidney Injury diagnosis
  • patients deemed clinically unstable by Nephrologist
  • active foot ulcer
  • unable to provide written consent
  • refusal of participation
  • lower limb amputations
  • patients with dementia or severe cognitive impairment
  • patients with Psychiatric disorders (who are not treated and unstable)
  • myocardial infarction in the last 6 months
  • uncontrolled diabetes
  • patients on chronic Midodrine therapy for intradialytic blood pressure support.
  • deep vein thrombosis
  • symptomatic peripheral vascular disease and/or recent lower extremities vascular intervention (i.e. bypass)

结局指标

主要结局

Change in Beck Depression Inventory (BDI) Score

时间窗: Week 1, Week 10

BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score \> 40 indicates extreme depression.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验