Exercise Training in Women With Metastatic Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Exercise: The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting the major muscle groups of the upper and lower body to improve strength and muscle mass. Six to eight exercises were performed using body weight, resistance bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the Borg 0-10 rating of perceived exertion scale, when health status allowed. The aerobic component consisted of walking, progressing to beginner-level running using short running intervals (50-100 m) interspersed with walking until longer continuous distances were achieved. Heart rate was monitored throughout the aerobic session.

Study summary

The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.

Eligibility

Primary outcome measure(s)

• Cardiorespiratory endurance and functional capacity — Baseline and week 24 (post exercise intervention)
  6MWT was performed as a parameter of cardiorespiratory endurance and functional capacity. Participants were instructed to walk back and forth along a flat, straight 25m corridor for six minutes, covering as much distance as possible at a self-selected pace. The total distance walked (in meters) was recorded as the primary outcome.
• Lower-limb muscle strength — Baseline and week 24 (post exercise intervention)
  Lower-limb muscle strength was assessed using the five-repetition sit-to-stand test (5xSTS), according to the European Working Group on Sarcopenia in Older People (EWGSOP2)¹. Participants were instructed to stand up and sit down five times as quickly as possible, with their arms crossed over the chest. The total time to complete the test was recorded in seconds (s) and used as an indicator of muscle strength. All assessments were performed by a trained evaluator
• Handgrip strength — Baseline and week 24 (post exercise intervention)
  Muscle strength was assessed using a handgrip dynamometer (SH5001, Saehan Grip, South Korea). Participants performed three maximal voluntary contractions with each hand in an alternating sequence, with a one-minute rest interval between trials. The highest value (kg) achieved was used for analysis. All measurements wer

Trial sites (1)

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