Exercise Post-Diagnosis of Breast Cancer

NCT04013568 | Completed DMC

• 1 other identifier: Fukui-2019-1
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are doing this study to determine if there are body composition changes after a 12-week exercise program in breast cancer patients and determine what factors contribute to sustained physical activity after the 12-week exercise program intervention.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (11)

• Fat mass

  Measure fat mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  1 day

• Isometric peak torque

  Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device

  1 day

• Lean mass

  Measure lean mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  1 day

• Bone mass

  Measure bone mass (arms, legs, trunk and total) in kg using Dual energy X-ray absorptiometry (DXA) data

  1 day

• Waist to Hip ratio (WHR) from manual tape measurement

  Manual physical anthropometry of waist and hip circumferences

  1 day

• Automatic 3D optical (3DO) scan measurement: girth measurement

  Automated 3DO measurements generate the following: girth in cm measurements across the whole body

  1 day

• Muscle Function

  Measure the peak torque value generated during isometric knee extension/flexion movement evaluation at 60 degrees will be assessed with the HUMAC NORM device

  1 day

• Percent fat

  Percent fat (arms, legs, trunk and total) using Dual energy X-ray absorptiometry (DXA) data

  1 day

• Automatic 3D optical (3DO) scan measurement: length measurement

  Automated 3DO measurements generate the following: length in cm measurements across the whole body

  1 day

• Automatic 3D optical (3DO) scan measurement: volume measurement

  Automated 3DO measurements generate the following: volume in cm measurements across the whole body

  1 day

• Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data

  Bone Mineral Density (spine and total) using Dual energy X-ray absorptiometry (DXA) data

  1 day

Secondary Outcomes (7)

• Recurrence Free Survival

  5 years

• BIBCQ-Body Image After Breast Cancer questionnaire

  5 years

• BFI-Brief Fatigue Innovatory questionnaire

  5 years

• PHQ-9- Patient Health (Depression) questionnaire

  5 years

• FACT-G-Functional Assessment of Cancer Therapy-General (Comorbidities)questionnaire

  5 years

Study Arms (2)

Group 1 - Agree to Exercise Program

ACTIVE COMPARATOR

12-week exercise program

Other: Exercise

Group 2 - Declines Exercise Program

NO INTERVENTION

Same biometric and biomarker assessment at as Group 1 (at baseline, after 12 weeks and annually) however they will not participate in the exercise sessions

Interventions

Exercise OTHER

First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes

Group 1 - Agree to Exercise Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New diagnosis of breast cancer (within the past 2 years, any subtype, stage I-III)
• Can be undergoing neo/adjuvant treatment (surgery, chemotherapy, radiation or endocrine therapy)
• Participant is willing and able to comply with the protocol for the duration of the study including undergoing scheduled exercise sessions, completing questionnaires and biometric/biomarker studies
• Participant must be able to lie flat on their back for up to 10 minutes
• Participant must be able to stand without aid for at least 2 minutes

You may not qualify if:

• Participant with breast cancer recurrence
• Metastatic breast cancer
• Uncontrolled psychiatric disorder that can affect self-assessment
• Pregnant patient
• Participants with any internal artifact (e.g. pacemakers, internal fixation, arthroplasty) or other physical impairment that would alter the body composition assessment

Sponsors & Collaborators

• University of Hawaii: lead
• Rehabilitation Hospital of the Pacific: collaborator

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jami Fukui, MD

  University of Hawaii Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants choose the initial intervention (12-week exercise program (Group1) vs monitoring (Group2)).

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: July 9, 2019
• Study Start: August 28, 2019
• Primary Completion: March 6, 2026
• Study Completion: March 6, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)