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临床试验/NCT02734394
NCT02734394进行中(未招募)不适用

UW WELL-FIT Exercise Program for Cancer Patients

University of Waterloo2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Maximal Exercise Test

研究概览

简要总结

The purpose of this project is to help to manage the many cancer treatment side effects through cardiovascular and resistance exercise, and education with the goal of using program outcomes to contribute to current research.

详细描述

This study is a single group pre-test post-test design.There are 4 optional measures that will be presented to participants from which they can choose to participate or not. These are presented with check boxes in the consent form. After completion of the University of Waterloo (UW) WELL-FIT program, participants will be given an option to continue with an exercise program; they will be offered the Graduate Program. Following consent of Graduate Program, repeated measures would be taken annually. At the time of consent, they will have the option to have their data used in research. At any point in their involvement of the exercise based programs, they can indicate "they no longer want to participate in the program or the data collection". Their medical care or participation in the UW WELL-FIT program will not be affected.

Procedures

  1. UW WELL-FIT advertisement for Grand River Regional Cancer Centre

  2. UW WELL-FIT brochure

  3. Referral Form

  4. Participants initial consultation and assessment

  5. Obtain consent for UW WELL-FIT

  6. Obtain Participant Information

  7. Completion of FACIT-F survey

  8. Metabolism & Body Composition - Information sheet for optional measures

  9. Physical Activity Survey- Godin Questionnaire

  10. Provide 3-Day food diary and Nutritional Assessment

  11. Fitness assessment, exercise programming and data entry:

  12. Submaximal cardiovascular cycle ergometer or treadmill graded exercise test

  13. Muscular strength using force transducer

  14. Body composition:

  • Height, weight and waist girth
  • Bioelectrical Impedance Analysis (BIA)
  • Dual Energy X-ray Absorption (Optional)
  1. Range of motion using a goniometer
  2. Blood sampling (Optional)
  3. Design Individualized exercise program
  4. UW WELL-FIT - Commencement of participant in 12 week exercise program (2 x 60 minute classes)
  5. Post assessment (repeated pre-test assessments)
  6. Pre and post data are entered into database
  7. Summary and Feedback Report
  8. Graduate Program: participant selects to attend UW WELL-FIT Graduate Program
  9. Participants have annual reassessments in the Graduate Program

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

性别
All
接受健康志愿者

入选标准

  • previously diagnosed with cancer and will currently be receiving some form of treatment (chemotherapy, radiation therapy or hormonal therapy)

排除标准

  • Physical / health factors that prohibit exercise or lack of medical clearance from physician

结局指标

主要结局

Maximal Exercise Test

时间窗: 24 sessions (12 weeks)

Pre and post maximum workload using an electronic cycle ergometer in Watts

Percent Body Fat

时间窗: 24 sessions (12 weeks)

Pre and Post percent body fat (units: %)

Upper and Lower Limb Strength

时间窗: 24 sessions (12 weeks)

pre and post strength in upper and lower limb muscles using a linear differential variable transducer (LVDT) measured in Newton.meters

Body Mass Index

时间窗: 24 sessions (12 weeks)

Pre and post body mass index (kg/m2)

次要结局

  • Glucose(24 sessions (12 weeks))
  • Lipids(24 sessions (12 weeks))

研究者

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

Julia Fraser

Research and Operations Manager

University of Waterloo

研究点 (2)

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