CClinicalTrials.gg
Status unknownNCT04679090CanEXUpdated Feb 18, 2021

Physical Activity Levels and Functional Improvement in Breast Cancer Survivors

An interventional study of Exercise Program in Breast Cancer, sponsored by University of New Brunswick. Status unknown at 3 sites in Canada. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by University of New Brunswick · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Sep 2018, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
19 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of New Brunswick is the lead sponsor of 19 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Participant

    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

Interventions

  • OtherExercise Program

    Participants will exercise twice a week for twelve weeks total.

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What researchers measure

Primary outcomes

  1. Walking speed

    6-minute walk test (meters walked)

    Time frame: Pre and post (after 12 weeks)

  2. Balance

    One leg stand test (seconds)

    Time frame: Pre and post (after 12 weeks)

  3. Strength, Hand grip

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

    Time frame: Pre and post (after 12 weeks)

  4. Strength, Chair stand test

    Chair stand test, number of chair stand in 30 seconds

    Time frame: Pre and post (after 12 weeks)

  5. Flexibility, back scratch test

    Back scratch test (cm)

    Time frame: Pre and post (after 12 weeks)

  6. Flexibility, sit and reach

    Sit and reach test

    Time frame: Pre and post (after 12 weeks)

  7. Physical Activity Level

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

    Time frame: Pre and post (after 12 weeks)

Secondary outcomes

  1. Attendance

    Amount of exercise sessions attended during the 12-week program

    Time frame: Pre and post (after 12 weeks)

  2. Weight

    Weight of individual (kg)

    Time frame: Pre and post (after 12 weeks)

  3. Height

    Height of individual (cm)

    Time frame: Pre and post (after 12 weeks)

  4. Resting Blood Pressure

    Systolic and diastolic blood pressure (mmHg)

    Time frame: Pre and post (after 12 weeks)

  5. Resting Heart Rate

    Resting heart rate (beats per minute)

    Time frame: Pre and post (after 12 weeks)

  6. Body-mass Index

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

    Time frame: Pre and post (after 12 weeks)

  7. Waist Circumference

    Measurement around the waist (cm)

    Time frame: Pre and post (after 12 weeks)

  8. FANTASTIC Lifestyle Checklist

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

    Time frame: Pre and post (after 12 weeks)

  9. 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

    Time frame: Pre and post (after 12 weeks)

  10. Functional Assessment of Cancer Therapy Fatigue (FACT - F)

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

    Time frame: Pre and post (after 12 weeks)

  11. 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.

    Time frame: Pre and post (after 12 weeks)

  12. Pittsburgh Sleep Quality Index (PSQI)

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

    Time frame: Pre and post (after 12 weeks)

  13. Godin-Shephard Leisure-Time Physical Activity Questionnaire

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

    Time frame: Pre and post (after 12 weeks)

  14. Age

    Age (years)

    Time frame: Pre and post (after 12 weeks)

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Study locations

3 of 3 sites recruiting
  • University of New Brunswick
    Fredericton, New Brunswick, Canada
    Recruiting
  • Memorial University of Newfoundland
    St. John's, Newfoundland and Labrador, Canada
    Recruiting
  • University of Prince Edward Island
    Charlottetown, Prince Edward Island, Canada
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04679090
Lead sponsor
University of New Brunswick
Collaborators
Ultramar, Quebec Breast Cancer Foundation
Responsible party
Sponsor
First posted
Dec 22, 2020
Start date
Sep 11, 2018
Primary completion
Apr 2021 (estimated)
Completion
Apr 2021 (estimated)
Last update
Feb 18, 2021

Study contacts

Danielle Bouchard
Contact
dboucha1@unb.ca
5064433908
Danielle Bouchard
principal investigator · University of New Brunswick

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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