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Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

Not Applicable
Conditions
Breast Cancer
Interventions
Other: Exercise Program
Registration Number
NCT04679090
Lead Sponsor
University of New Brunswick
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
20
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ParticipantExercise ProgramParticipants 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.
Primary Outcome Measures
NameTimeMethod
Strength, Chair stand testPre and post (after 12 weeks)

Chair stand test, number of chair stand in 30 seconds

Walking speedPre and post (after 12 weeks)

6-minute walk test (meters walked)

Strength, Hand gripPre and post (after 12 weeks)

Amount of force that can be exerted during grip squeeze (kg)

BalancePre and post (after 12 weeks)

One leg stand test (seconds)

Flexibility, back scratch testPre and post (after 12 weeks)

Back scratch test (cm)

Flexibility, sit and reachPre and post (after 12 weeks)

Sit and reach test

Physical Activity LevelPre and post (after 12 weeks)

Pedometer to determine minutes in moderate-vigorous physical activity and steps per day

Secondary Outcome Measures
NameTimeMethod
Waist CircumferencePre and post (after 12 weeks)

Measurement around the waist (cm)

Resting Blood PressurePre and post (after 12 weeks)

Systolic and diastolic blood pressure (mmHg)

Pittsburgh Sleep Quality Index (PSQI)Pre and post (after 12 weeks)

A self-report questionnaire that assesses sleep quality over a 1-month time interval

Godin-Shephard Leisure-Time Physical Activity QuestionnairePre and post (after 12 weeks)

Questionnaire used to identify self-reported leisure-time physical activity

WeightPre and post (after 12 weeks)

Weight of individual (kg)

AttendancePre and post (after 12 weeks)

Amount of exercise sessions attended during the 12-week program

HeightPre and post (after 12 weeks)

Height of individual (cm)

Body-mass IndexPre and post (after 12 weeks)

Measure of body fat based on height and weight (kg/m\^2)

AgePre and post (after 12 weeks)

Age (years)

FANTASTIC Lifestyle ChecklistPre and post (after 12 weeks)

Meaningful improvement above day-to-day variability on the 6MWT

Resting Heart RatePre and post (after 12 weeks)

Resting heart rate (beats per minute)

Functional Assessment of Cancer Therapy General (FACT - G)Pre and post (after 12 weeks)

27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being

Depression Anxiety Stress Scales (DASS)Pre and post (after 12 weeks)

42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.

Functional Assessment of Cancer Therapy Fatigue (FACT - F)Pre and post (after 12 weeks)

40-item measure that assesses self-reported fatigue and its impact upon daily activities and function

Trial Locations

Locations (3)

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, Canada

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