跳至主要内容
临床试验/NCT05921552
NCT05921552进行中(未招募)不适用

Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery

H. Lee Moffitt Cancer Center and Research Institute2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年6月26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)
入组人数
25
试验地点
2
主要终点
Percentage of Participants that Complete Study Assessments - Retention Feasibility

研究概览

简要总结

The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.

研究设计

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

入排标准

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

入选标准

  • Age ≥65 years
  • Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
  • Able to sign consent

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

Percentage of Participants that Complete Study Assessments - Retention Feasibility

时间窗: Up to 3 Months

Retention will be considered feasible if ≥70% of participants complete study measures

Participant Self-Reported Musculoskeletal Injuries - Safety

时间窗: Up to 3 Months

The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator for the safety variable will be the number of exercise training sessions attended by the participant.

Objective Physical Functioning and Fitness

时间窗: At Baseline and Up to 3 Months

Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.

Percentage of Participants that Enroll and Consent - Enrollment Feasibility

时间窗: Up to 12 Months

Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll

Adherence - Feasibility

时间窗: Up to 3 Months

Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week

Exercise Training Safety

时间窗: Up to 3 Months

Number of participants that reported any exercise-related musculoskeletal injuries or other adverse health events (e.g.,extreme fatigue, shortness of breath, heat-related illness, cardiovascular events, changes in medication) incurred over the course of the intervention.

Participant Evaluation of Feasibility and Acceptability - Acceptability

时间窗: Up to 3 Months

Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.

Social Support

时间窗: At Baseline and Up to 3 Months

Participants social support will be measured using two scales, the Multidimensional Scale of Perceived Social Support (a valid 12-item measure assessing perceived adequacy of general social support from friends, family, and significant others) and the Social Influence Scale for Exercise (positive influences) (a valid 15-item measure assessing perceived adequacy of exerciserelated social support from friends, family, and experts)

Participant Self Reported Exercise

时间窗: At Baseline and Up to 3 Months

Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise

Participant Skeletal Muscle Index (SMI)

时间窗: At Baseline and Up to 3 Months

Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans

Participants Health-Related Quality of Life

时间窗: At Baseline and Up to 3 Months

Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey

Patient Activation

时间窗: At Baseline and Up to 3 Months

Participants patient activation will be measured using the Patient Activation Measure Short Form that is a valid and reliable 13-item scale for measuring patient's self-reported knowledge, skill, and confidence for self-management.

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 (2)

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