跳至主要内容
临床试验/NCT03750981
NCT03750981招募中不适用

Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Study of CrossFit® in Cancer Survivors

Barbara Ann Karmanos Cancer Institute2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年11月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
2
主要终点
Enrollment rates

研究概览

简要总结

This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.

详细描述

A 12-week pilot intervention study introducing a high-intensity functional training program to 100 cancer survivors and evaluate the effects of this program on patient quality of life, functional capacity, and body composition. Response rates will be determined using various recruitment methods and estimate differences in response rates by patient characteristics including race, gender and age. Barriers to participation in the program in contacted patients who do not enroll as well as patients who enroll and do not complete the program will be described, as will participant satisfaction with enrolled participants who complete the program. The goal of this pilot study is to help refine the recruitment and program methods for a larger intervention study to test the superiority of a high-intensity interval functional training program compared with current American Cancer Society guidelines in improving functional capacity, body composition and patient reported quality of life.

Surveys will be completed by each participant weekly and physical assessments will be completed monthly.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Aged 18 years or older at time of program recruitment
  • Diagnosed with any cancer
  • Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
  • Available transportation to and from the facility on session days
  • Exclusion Criteria
  • Widely metastatic cancers to the brain or bone may be excluded.
  • Patients using mobility assistance devices may be excluded. Exclusionary criteria will be reviewed on a case-by-case basis and patients with these limitations may be included with approval from Dr. Beebe-Dimmer and the referring physician.

排除标准

  • 未提供

结局指标

主要结局

Enrollment rates

时间窗: Baseline

Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll

Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire

时间窗: Baseline to 12 weeks

Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.

Satisfaction with the Program

时间窗: 12 weeks

Satisfaction with the program will be collected via a survey

Change in Motivation

时间窗: Baseline to 12 weeks

Motivation to exercise will be collected via a survey

Program Adherence

时间窗: 12 weeks

Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.

Height

时间窗: Baseline

Height will be collected in meters to use in the calculation of Body Mass Index

Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program

时间窗: Baseline to 12 weeks

Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups.

Change in Body Composition

时间窗: Baseline to 12 weeks

Changes in weight in kg

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

Jennifer Beebe-Dimmer, PhD

Principal Investigator

Barbara Ann Karmanos Cancer Institute

研究点 (2)

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