C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)

Cancer Survivors Clinical Trial

— CAPABLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03750981
• Other study ID #: 2018-091
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: May 30, 2026

Study information

• Verified date: May 2024
• Source: Barbara Ann Karmanos Cancer Institute
• Contact: Jennifer B Beebe-Dimmer, MPH, PhD.
• Phone: (313) 578-4209
• Email: dimmerj[@]karmanos.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older at time of program recruitment

• Diagnosed with an invasive 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

Related Conditions & MeSH terms

• Cancer Survivors

Intervention

Behavioral:
• 12 week pilot intervention study.
Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.

Locations

Country	Name	City	State
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Barbara Ann Karmanos Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rates	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	Baseline
Primary	Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program	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.	Baseline to 12 weeks
Primary	Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program	Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded.	Baseline to 12 weeks
Primary	Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program	Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.	Baseline to 12 weeks
Primary	Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire	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.	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in weight in kg	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in body fat percentage	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in visceral fat percentage	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in muscle mass percentage	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2	Baseline to 12 weeks
Primary	Change in Body Composition	Changes in resting metabolism value	Baseline to 12 weeks
Primary	Change in Motivation	Motivation to exercise will be collected via a survey	Baseline to 12 weeks
Primary	Satisfaction with the Program	Satisfaction with the program will be collected via a survey	12 weeks
Primary	Program Adherence	Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.	12 weeks
Primary	Height	Height will be collected in meters to use in the calculation of Body Mass Index	Baseline