Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Breast Cancer - Female
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Parallel assignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

The aim of this study is to investigate the effects of heavy-load resistance training on muscle cellular outcomes in women with breast cancer undergoing (neo-)adjuvant chemotherapy. More specifically, the investigators' objectives are to Investigate the effects of a heavy-load resistance training in...

The aim of this study is to investigate the effects of heavy-load resistance training on muscle cellular outcomes in women with breast cancer undergoing (neo-)adjuvant chemotherapy. More specifically, the investigators' objectives are to Investigate the effects of a heavy-load resistance training intervention on skeletal muscle fiber cross-sectional area. Investigate the effects of a heavy-load resistance training intervention on regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function. Investigate the effects of chemotherapy on skeletal muscle fiber cross-sectional area, regulators of muscle fiber size, muscle fiber function, cellular stress and mitochondrial function. Explore the effects of heavy-load resistance training on the expression levels of myokines. This study is a two-armed randomized controlled trial with follow-up at six months. With this design, the investigators can study the main effect and interactions between factors (groups). Participants will be randomized to either an intervention group or a control group. Participants recently diagnosed with breast cancer will be recruited from Uppsala University Hospital. Based on power calculations, 50 participants will be included. Data will be collected before the first cycle of chemotherapy, after chemotherapy, and 6 months later (6-month follow-up. Participants in the intervention group will perform supervised heavy-load resistance training twice a week from the week following the start of chemotherapy and throughout the course of treatment, approximately 16 weeks. Sessions will be performed at a public gym and led by trained coaches. The following six exercises will be included in the program: seated leg-press, seated chest press, seated leg-curl, seated row and seated leg-extension performed in machines and seated overhead-press using dumbbells. The first two weeks of the program represent familiarization to the training protocol and 1 RM (Repetition Maximum) tests. During this period, the participants will perform exercises at a light load. After the first 1 RM-test, training will progress in sets and training load before testing of 6- and 10 RM which will provide the participants with individualized loads. Rest periods between sets will be two (6 RM training load) and one minute (10 RM training load) for the two different sessions, respectively. The training load will be adjusted throughout the intervention period. Participants in the control group are encouraged to continue with their activity as usual i.e. maintain their habitual physical activity level and not initiate resistance training during chemotherapy. To increase interest in participation, controls will be invited to a 2-week introduction to the same resistance-training program as the intervention group following completion of chemotherapy and offered a 12-month membership at a local gym, free of charge.

Tracking Information

NCT #
NCT04586517
Collaborators
  • Swedish Cancer Society
  • Norwegian Cancer Society
  • Norwegian School of Sport Sciences
  • University of Agder
  • Rigshospitalet, Denmark
  • Uppsala University Hospital
Investigators
Principal Investigator: Truls Raastad, PhD Norweigan School of Sport Sciences Principal Investigator: Karin Nordin, PhD Uppsala University