Adaptive Training Exercise Programs for Improving Cardiorespiratory Fitness After Breast Cancer Treatment, The ACTIVATE Trial

NCT04667481 | Completed Results

• 4 other identifiers: RG1121129P30CA01570410872NCI-2021-01114
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies the feasibility of implementing various adaptive training exercise programs to improve cardiorespiratory fitness in patients after receiving breast cancer treatment. Information from this study may help researchers better understand how to implement adaptive training interventions to improve cardiorespiratory fitness in patients after receiving breast cancer treatment.

Conditions

Breast Cancer; Invasive Breast Carcinoma

Keywords

breast cancer; exercise; fatigue; fitness; aerobic; survivor

Outcome Measures

Primary Outcomes (1)

• Intervention Feasibility

  Will be determined with all-cause intervention discontinuation rate, which is the proportion of all intervention participants who permanently stop the intervention prior to week 24 for any reason.

  Week 24

Secondary Outcomes (5)

• Intervention Safety: Adverse Events

  Up to 24 weeks

• Study Feasibility

  Up to 24 weeks

• Intervention Acceptability

  Up to 24 weeks

• Intervention Session Intensity

  Up to 24 weeks

• Intervention Adherence

  Up to 24 weeks

Other Outcomes (14)

• Maximal Exercise Capacity (Absolute)

  Up to 24 weeks

• Maximal Exercise Capacity (Relative to Bodyweight)

  Up to 24 weeks

• Submaximal Exercise Capacity

  Up to 24 weeks

Study Arms (3)

Arm I (aerobic exercise)

EXPERIMENTAL

Patients participate in AE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders participate in combined AE and RE sessions for an additional 12 weeks, while responders continue participating in the AE sessions alone for an additional 12 weeks.

Other: Aerobic Exercise Intervention; Other: Resistance Exercise Intervention; Other: Quality-of-Life Assessment

Arm II (resistance exercise)

EXPERIMENTAL

Patients participate in RE sessions 3 times per week for 12 weeks. After 12-weeks, non-responders may participate in a further 12-weeks of combined AE and RE sessions, while responders continue participating in the RE sessions alone for an additional 12 weeks.

Other: Aerobic Exercise Intervention; Other: Resistance Exercise Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Control Group (digital exercise interventions)

EXPERIMENTAL

After 24 weeks, patients receive a digital copy of the 12-week AE sessions and 12-week RE sessions and an outline of sessions for 24 weeks.

Other: Exercise Intervention: Digital copies and outline of sessions; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

Interventions

Aerobic Exercise Intervention OTHER

Participate in aerobic exercise intervention

Arm I (aerobic exercise); Arm II (resistance exercise)

Resistance Exercise Intervention OTHER

Participate in resistance exercise intervention

Arm I (aerobic exercise); Arm II (resistance exercise)

Exercise Intervention: Digital copies and outline of sessions OTHER

Receive digital copy of AE and RE sessions and an outline of sessions

Control Group (digital exercise interventions)

Questionnaire Administration OTHER

Ancillary studies

Arm II (resistance exercise); Control Group (digital exercise interventions)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (aerobic exercise); Arm II (resistance exercise); Control Group (digital exercise interventions)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 75 years, inclusive
• Female gender
• Prior diagnosis of invasive breast cancer
• Completion of chemotherapy or receipt of trastuzumab (Herceptin) therapy within the past 6 - 60 months (0.5 - 5 years)
• Reduced cardiorespiratory functional capacity, defined as below the median estimated CRF for age/sex-matched controls

You may not qualify if:

• Actively receiving radiation treatment
• Medical history of heart failure, coronary artery disease or arrhythmia
• Contraindications to cardiopulmonary exercise testing (CPET)
• Contraindications to magnetic resonance imaging (MRI) (e.g ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices, non-compatible MRI tissue expanders or breast implants, or other implanted non-compatible MRI devices), weight over 550 lbs, or symptomatic claustrophobia
• Contraindications to exercise, including a history of surgery with sequelae that restrict ability to exercise safely or comfortably
• Unwilling to complete intervention procedures or outcome measures

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Kerryn Reding, Study Principal Investigator
• Organization: University of Washington

kreding@uw.edu

206-221-1571

Study Officials

• Kerryn W Reding, PhD, MPH, RN

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 14, 2020
• Study Start: January 5, 2022
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: February 12, 2024
• Results First Posted: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)