跳至主要内容
临床试验/NCT06610396
NCT06610396进行中(未招募)不适用

Ex Onc SLED: A Pilot Study Utilizing A Weighted Sled for Horizontal Resistance Training

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
2
主要终点
Change in Adipose Tissue (InBody, kg)

研究概览

简要总结

This protocol seeks to analyze patient adherence and outcomes after monitored exercise sessions utilizing primarily weighted sled pushes and pulls for linearly progressed resistance training of individuals who have been diagnosed with cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-89 years
  • Women of child-bearing potential must verbally confirm lack of pregnancy prior to enrollment. They should also consent to use adequate contraception during the course of the study.
  • Participants must be determined capable of engaging in resistance training by exercise personnel and/or study PI and must be able to stand.
  • Participants must complete an assessment by EOC staff and be determined safe to engage in the workout regimen by the study exercise personnel. Any individuals not deemed safe to participate in the basic EOC exercise program will be referred to physical therapy or elsewhere

排除标准

  • Severe arthritic, joint, cardiovascular, or musculoskeletal condition that would interfere with exercise program
  • Individuals deemed able to engage in more intense resistance training utilizing compound movements will not be eligible
  • Pregnant women

结局指标

主要结局

Change in Adipose Tissue (InBody, kg)

时间窗: Baseline and study completion, up to 6 months.

Change in adipose tissue (kg) pre and post resistance training regimen measured via InBody 970 bioelectrical impedance analysis

Change in Adipose Tissue (Ultrasound, Lbs)

时间窗: Baseline and study completion, up to 6 months.

Change in adipose tissue (pounds) pre and post resistance training regimen measured via ultrasound.

Change in Muscle Mass

时间窗: Baseline and study completion, up to 6 months.

Changes in percent muscle mass (measured by InBody bioelectrical impedance analysis) and percent fat-free mass (measured by ultrasound) from baseline to six months

次要结局

  • Intervention Compliance Rate during Exercise Program (Adherence)(Through study completion, up to 6 months.)
  • Feasibility of the Exercise Program(Through study completion, up to 6 months.)
  • Adverse Events (Safety)(Through study completion, up to 6 months.)
  • Changes in Timed Up and Go Test Performance at baseline and post-exercise assessment(Baseline and study completion, up to 6 months.)
  • Changes in Functional Mobility Score at baseline and post-exercise assessment(Baseline and study completion, up to 6 months.)
  • Changes in Y-Balance Test Scores at baseline and post-exercise assessment(Baseline and study completion, up to 6 months.)
  • Changes in EuroQol-5 Dimensions (EQ-5D) at baseline and post-exercise assessment(Baseline assessment (prior to program) and at exercise program completion.)
  • Changes in Patient Health Questionnaire-9 (PHQ9) depression score at baseline and post-exercise assessment(Baseline and study completion, up to 6 months.)
  • Changes in General Anxiety Disorder-7 (GAD7) anxiety score at baseline and post-exercise assessment(Baseline and study completion, up to 6 months.)
  • Changes in grip strength at baseline, throughout, and post- exercise assessment(Through study completion, up to 6 months.)
  • Changes in load lifted during sled exercises at baseline, throughout, and post- exercise assessment(Through study completion, up to 6 months.)
  • Changes in resting metabolic rate at baseline and post-exercise assessment(Through study completion, up to 6 months.)

研究者

发起方
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Colin Champ, MD

Radiation Oncologist

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

研究点 (2)

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