Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Exercise Program


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant<br>Participants will answer a series of questionnaires, wear a physical activity tracker (pedometer) and do functional tests (six minute walk test, chair stand test, balance, back scratch, sit and reach, leg strength and hand strength) pre and post. | Other: Exercise Program<br>* Participants will exercise twice a week for twelve weeks total.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking speed | 6-minute walk test (meters walked) | Pre and post (after 12 weeks) | 
| Balance | One leg stand test (seconds) | Pre and post (after 12 weeks) | 
| Strength, Hand grip | Amount of force that can be exerted during grip squeeze (kg) | Pre and post (after 12 weeks) | 
| Strength, Chair stand test | Chair stand test, number of chair stand in 30 seconds | Pre and post (after 12 weeks) | 
| Flexibility, back scratch test | Back scratch test (cm) | Pre and post (after 12 weeks) | 
| Flexibility, sit and reach | Sit and reach test | Pre and post (after 12 weeks) | 
| Physical Activity Level | Pedometer to determine minutes in moderate-vigorous physical activity and steps per day | Pre and post (after 12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | Amount of exercise sessions attended during the 12-week program | Pre and post (after 12 weeks) | 
| Weight | Weight of individual (kg) | Pre and post (after 12 weeks) | 
| Height | Height of individual (cm) | Pre and post (after 12 weeks) | 
| Resting Blood Pressure | Systolic and diastolic blood pressure (mmHg) | Pre and post (after 12 weeks) | 
| Resting Heart Rate | Resting heart rate (beats per minute) | Pre and post (after 12 weeks) | 
| Body-mass Index | Measure of body fat based on height and weight (kg/m^2) | Pre and post (after 12 weeks) | 
| Waist Circumference | Measurement around the waist (cm) | Pre and post (after 12 weeks) | 
| FANTASTIC Lifestyle Checklist | Meaningful improvement above day-to-day variability on the 6MWT | Pre and post (after 12 weeks) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Godin-Shephard Leisure-Time Physical Activity Questionnaire | Questionnaire used to identify self-reported leisure-time physical activity | Pre and post (after 12 weeks) | 
| Age | Age (years) | Pre and post (after 12 weeks) |