Clinical trial NCT04679090: Physical Activity Levels and Functional Improvement in Breast Cancer Survivors
Official title: Do Physical Activity Levels Predict Functional Improvements Following a Structured Exercise Program for Women Living With Breast Cancer?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of New Brunswick
Sponsor class: OTHER
Collaborators: name: Ultramar
name: Quebec Breast Cancer Foundation
First posted: 2020-12-22
Enrollment: 20
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Walking speed
timeFrame: Pre and post (after 12 weeks)
measure: Balance
timeFrame: Pre and post (after 12 weeks)
measure: Strength, Hand grip
timeFrame: Pre and post (after 12 weeks)
measure: Strength, Chair stand test
timeFrame: Pre and post (after 12 weeks)
measure: Flexibility, back scratch test
timeFrame: Pre and post (after 12 weeks)
measure: Flexibility, sit and reach
timeFrame: Pre and post (after 12 weeks)
measure: Physical Activity Level
timeFrame: Pre and post (after 12 weeks)
Secondary outcomes:
measure: Attendance
timeFrame: Pre and post (after 12 weeks)
measure: Weight
timeFrame: Pre and post (after 12 weeks)
measure: Height
timeFrame: Pre and post (after 12 weeks)
measure: Resting Blood Pressure
timeFrame: Pre and post (after 12 weeks)
measure: Resting Heart Rate
timeFrame: Pre and post (after 12 weeks)
measure: Body-mass Index
timeFrame: Pre and post (after 12 weeks)
measure: Waist Circumference
timeFrame: Pre and post (after 12 weeks)
measure: FANTASTIC Lifestyle Checklist
timeFrame: Pre and post (after 12 weeks)
measure: Functional Assessment of Cancer Therapy General (FACT - G)
timeFrame: Pre and post (after 12 weeks)
measure: Functional Assessment of Cancer Therapy Fatigue (FACT - F)
timeFrame: Pre and post (after 12 weeks)
measure: Depression Anxiety Stress Scales (DASS)
timeFrame: Pre and post (after 12 weeks)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Pre and post (after 12 weeks)
measure: Godin-Shephard Leisure-Time Physical Activity Questionnaire
timeFrame: Pre and post (after 12 weeks)
measure: Age
timeFrame: Pre and post (after 12 weeks)
Other outcomes:
Locations:
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
city: St. John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
city: Charlottetown
country: Canada
facility: University of Prince Edward Island
state: Prince Edward Island
Study officials:
affiliation: University of New Brunswick
name: Danielle Bouchard
role: PRINCIPAL_INVESTIGATOR
References: