Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

Breast Cancer Clinical Trial

— CanEX  

Official title:

Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04679090
• Other study ID #: University Brunswick
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2018
• Est. completion date: April 2021

Study information

• Verified date: February 2021
• Source: University of New Brunswick
• Contact: Danielle Bouchard
• Phone: 5064433908
• Email: dboucha1[@]unb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of our project is to describe what characteristics (e.g., age, current physical activity level) women present when starting the exercise program are potentially associated with an improvement in functional abilities measured with different tests such as the distance you can cover while walking for six minutes.

Description:

The main research objective is to investigate the relationship between baseline physical activity and improvement in physical function, quantified using changes in 6-minute walk test (6MWT) results over the course of the 12-week program. An association is hypothesized to exist between the two variables even when adjusted for weeks into treatment. The goal of the 6MWT is to cover as much distance as possible in six minutes, using as many breaks s necessary. The test is often performed using a 20-meter hallway but requires no specific equipment. A recent study reported that the result of the 6MWT could be used as a measure of the major components of global health in women with breast cancer, making its use in our research especially relevant. Aside from physical functions, baseline characteristics will also be used to determine what characteristics, if any, are associated with health and psychosocial outcomes such as quality of life, social connectedness/support, and mental well-being. The data collected is certain to fill a gap in the literature, and will therefore be likely published in an important journal in the field.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Have received a diagnosis of breast cancer in your lifetime

• 19 years of age and older

• Cleared by medical team to participate in the study

• Have the intention to exercise at the facility for the duration of the study

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Exercise Program
Participants will exercise twice a week for twelve weeks total.

Locations

Country	Name	City	State
Canada	University of Prince Edward Island	Charlottetown	Prince Edward Island
Canada	University of New Brunswick	Fredericton	New Brunswick
Canada	Memorial University of Newfoundland	St. John's	Newfoundland and Labrador

Sponsors (3)

Lead Sponsor	Collaborator
University of New Brunswick	Quebec Breast Cancer Foundation, Ultramar

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	6-minute walk test (meters walked)	Pre and post (after 12 weeks)
Primary	Balance	One leg stand test (seconds)	Pre and post (after 12 weeks)
Primary	Strength, Hand grip	Amount of force that can be exerted during grip squeeze (kg)	Pre and post (after 12 weeks)
Primary	Strength, Chair stand test	Chair stand test, number of chair stand in 30 seconds	Pre and post (after 12 weeks)
Primary	Flexibility, back scratch test	Back scratch test (cm)	Pre and post (after 12 weeks)
Primary	Flexibility, sit and reach	Sit and reach test	Pre and post (after 12 weeks)
Primary	Physical Activity Level	Pedometer to determine minutes in moderate-vigorous physical activity and steps per day	Pre and post (after 12 weeks)
Secondary	Attendance	Amount of exercise sessions attended during the 12-week program	Pre and post (after 12 weeks)
Secondary	Weight	Weight of individual (kg)	Pre and post (after 12 weeks)
Secondary	Height	Height of individual (cm)	Pre and post (after 12 weeks)
Secondary	Resting Blood Pressure	Systolic and diastolic blood pressure (mmHg)	Pre and post (after 12 weeks)
Secondary	Resting Heart Rate	Resting heart rate (beats per minute)	Pre and post (after 12 weeks)
Secondary	Body-mass Index	Measure of body fat based on height and weight (kg/m^2)	Pre and post (after 12 weeks)
Secondary	Waist Circumference	Measurement around the waist (cm)	Pre and post (after 12 weeks)
Secondary	FANTASTIC Lifestyle Checklist	Meaningful improvement above day-to-day variability on the 6MWT	Pre and post (after 12 weeks)
Secondary	Functional Assessment of Cancer Therapy General (FACT - G)	27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being	Pre and post (after 12 weeks)
Secondary	Functional Assessment of Cancer Therapy Fatigue (FACT - F)	40-item measure that assesses self-reported fatigue and its impact upon daily activities and function	Pre and post (after 12 weeks)
Secondary	Depression Anxiety Stress Scales (DASS)	42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.	Pre and post (after 12 weeks)
Secondary	Pittsburgh Sleep Quality Index (PSQI)	A self-report questionnaire that assesses sleep quality over a 1-month time interval	Pre and post (after 12 weeks)
Secondary	Godin-Shephard Leisure-Time Physical Activity Questionnaire	Questionnaire used to identify self-reported leisure-time physical activity	Pre and post (after 12 weeks)
Secondary	Age	Age (years)	Pre and post (after 12 weeks)