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临床试验/NCT07715344
NCT07715344已完成1 期

Reducing Health Disparity of Physical Functioning Among Young Adult Cancer Patients of Color

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年11月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
89
试验地点
1
主要终点
Change 6-minute walk test

研究概览

简要总结

The purpose of the study is to pilot test of PAfitME™ among (1) young adults (YA) cancer patients of color (POC) (Analytic Sample [N=36] after attrition of 30%) and (2) YA cancer patients of White (POW) (Analytic Sample [N=36] after attrition of 30%).

Aim 1: Evaluate Exergame Grading Scheme (EGS) validity when EGS is tested in relationship to standard lab tests (Bruce Treadmill Protocol and isometric/isokinetic dynamometry) and field fitness tests (6-minute walk test, handgrip, and Chair Stand Test).

Aim 2a: Evaluate the feasibility (enrollment rate [% of eligible patients], attrition rate [% in either intervention or control group], adherence rate [% of completed prescribed exergame minutes]), safety (numbers of adverse events), and acceptability (satisfaction score & exit qualitative interviews) of PAfitME™.

Aim 2b: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POC.

Aim 2c: Evaluate the preliminary effect of 12-week PAfitME™ on cardiorespiratory fitness (6-minute walk test) and muscle strength (handgrip [upper body] and Chair Stand Test [lower body]) when compared with a usual care condition among YA cancer POW.

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 39 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • post-cancer treatment
  • age of 18-39 years old
  • ability to read and speak English
  • medical clearance of stress test (Bruce treadmill protocol)
  • no participation in an exercise program
  • complaint of functional decline after cancer diagnoses
  • complaint of fatigue or/and pain symptoms after cancer treatment.

排除标准

  • no cancer diagnosis
  • no participation of exercise programs

结局指标

主要结局

Change 6-minute walk test

时间窗: Baseline and Week 12

6-minute walk. The distance (in meters) walked in 6 minutes is measured.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsiao-Lan Wang

Professor

University of Alabama at Birmingham

研究点 (1)

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