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Breast Cancer Resiliency Through Exercise Program (B-REP): Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Women will be eligible if they meet the following criteria:

• self-identify as Black or African American or Afro-Latina/e;

• are ≥18 years old;

• have a confirmed diagnosis of breast cancer, Stage I to IIIA;

• have completed primary active treatment (i.e., surgery, chemotherapy, and radiation) within 5 years prior to study start where concomitant hormonal therapy is acceptable;

• are not meeting current cancer-specific resistance exercise guidelines of ≥ 2 times per week; and

• are able to speak and understand English.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Cancer AnswerLine
CancerAnswerLine@med.umich.edu
1-800-865-1125
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2026-12
Participants
Target number of participants: 75
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan Rogel Cancer Center

This content was sourced from clinicaltrials.gov