Breast Cancer Resiliency Through Exercise Program (B-REP)

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT06100263
Status
Recruiting
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Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Individualized exercise program — OTHER
    guided exercise program for 12 weeks
  • Control Arm — OTHER
    Control Arm Waiting List for 24 weeks, then offered a guided exercise program for 12 weeks

Study Details

The study will use a cross-sectional study design with a follow-up 2-arm randomized controlled trial with that has assessments at baseline, post-intervention (i.e., Week 12), and 3-months post-intervention (i.e., Week 24). The 2 arms are the 12-week intervention and waitlist control among 30 Black breast cancer survivors

Key Dates

Start date
May 28, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention (Supervised exercise)
    The individualized program is based on participants' baseline 5-repetition maximum muscular strength assessment and is aligned with current cancer-specific exercise recommendations. The resistance program will follow the FITT principle (frequency, intensity, time, and type): Frequency. Participants will aim for 3 resistance exercise sessions per week. Intensity. Resistance exercise intensity will have a schedule for increased progression by both load via increased weight and volume via increased repetitions and sets. If participants are not able to increase resistance loads as scheduled, they will remain at their current load and volume until the next scheduled increase. 50% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 60% of 5-repetition maximum for upper and lower body. 3 sets of 8 to 12 repetitions. 70% of 5-repetition maximum for upper and lower body. 4 sets of 8 to 12 repetitions.
  • Active Comparator: Control (waitlist)
    Participants randomized to the waitlist control condition will be on a waiting list for 24 weeks. Participants in waitlist control condition will complete measures on the same schedule as intervention participants. After 24 weeks, participants will be offered to participate in the online sessions with an exercise trainer using Zoom twice per week for 12- weeks. The sessions will be 30 to 45minutes in length.

Primary Outcome Measure

Feasibility of the exercise program (Retention) [ Time Frame: up to 24 weeks after start of intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Cancer AnswerLine
[email protected]
800-865-1125
Angela Fong, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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