Exercise to ReGain Stamina and Energy (The EXERGISE Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60-105
SponsorUniversity of Florida
About this trial
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consent to participate in the study
Age ≥ 60 years old
Had stage I-III invasive breast cancer
The cancer is diagnosed in 2021 or 2022
Disqualifiers
Failure to provide informed consent
Current involvement in rehabilitation program
Absolute contraindications to exercise training
Significant cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
Center-Based Walking Exercise
BehavioralEach exercise session will begin with a short warm-up followed by 30 min of walking. Participants will initially be instructed to walk at a moderate intensity, equivalent to a 5-6 on Borg category-ratio (CR) scale. Participants will be encouraged to, if possible, incorporate brief periods of vigorous walking (7-8 on CR10 scale) with a goal of achieving at least 10 min of vigorous walking per session.
Home-Based Walking Exercise
BehavioralParticipants will be asked to walk for exercise in their community five days/week. Participants will be instructed to begin with 10-15 minutes of walking exercise/session in the first month of the intervention and to increase exercise duration by five minutes/session each week, facilitating reasonable but steady progress toward the goal of 30 minutes per session.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Center-Based Walking ExerciseExperimental treatment 1 intervention
Group B: Home-Based Walking ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Self-Reported Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
Time frame
Baseline up to Week 8Secondary outcomes
1
Mental Distress (Depression and Anxiety)
Mental distress (depression and anxiety) in past 7 days will be measured by PROMIS. Participants will answer 8 and 7 questions to reflect severity of depression and anxiety, respectively; for each question, a 5-point scale and normalized T-scores will be employed as measure of fatigue.
Time frame
Baseline up to Week 82
Self-Reported Pain
Self-reported pain in past 7 days will be measured by 6 questions in PROMIS Pain Interference Short Form; the questions measure severity of pain and use a 5-point scale (1=not at all; 2=a little bit; 3=somewhat; 4=quite a bit; 5=very much) whose sum can be transformed to a normalized T-score.
Time frame
Baseline up to Week 83
Self-Reported Sleep Disturbance
Self-reported sleep short form (8a) that assesses the pure domain of sleep disturbance in individuals aged 18 and older. Each item on the measure is rated on a 5-point scale (1=very good; 2=good; 3=fair; 4=poor; and 5=very poor) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance whose sum can be transformed to a normalized T-score.
Time frame
Baseline up to Week 84
Gait Speed
Gait speed will be assessed in by the 6 Minute Walk test, which measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. Gait speed will be measured by approach used in the National Health and Nutrition Examination Survey; participants will be asked to finish a 20-foot walking test and gait speed will be calculated as (20×0.3048 meter)/(time (seconds) to finish test).
Time frame
Baseline up to Week 8Sponsors and contacts
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Source ClinicalTrials.gov