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Effect of Physical Training Program on the Exercise Adherence for Breast Cancer Survivor

U

Universidad de Burgos

Status

Completed

Conditions

Breast Cancer Stage II
Breast Cancer Stage I
Breast Cancer Stage III
Breast Cancer Stage IIIA

Treatments

Other: concurrent
Behavioral: Health Education Session

Study type

Interventional

Funder types

Other

Identifiers

NCT06771635
2018/0009

Details and patient eligibility

About

Breast cancer (BC) is one of the most common cancers among women worldwide, with survival rates steadily improving due to advances in early detection and treatment. Despite these improvements, survivors frequently experience long-term side effects such as fatigue, reduced physical function, osteosarcopenia (loss of muscle mass and bone density), and diminished quality of life (QOL). These sequelae often lead to loss of independence, increased frailty, and reduced participation in daily activities. Physical activity, particularly structured and supervised programs, has been shown to mitigate many of these effects. Concurrent training, which combines strength, cardiovascular, and neuromotor exercise, provides a comprehensive approach that targets muscle mass, bone health, and functional mobility. However, adherence to regular physical activity in this population remains low, with most survivors not achieving recommended levels of at least 150 minutes per week of moderate-to-vigorous exercise. This pilot randomized controlled trial aims to evaluate the effects of a 6-week supervised concurrent training program in breast cancer survivors. The program includes 12 supervised sessions designed to improve exercise adherence, physical activity levels, and QOL. The intervention is compared with a control group that receives only a health education session. Outcomes include QOL assessed by the FACT-B questionnaire, physical activity levels measured by the GPAQ, sedentary time, functional fitness, anthropometry, and patient satisfaction. The study is expected to provide evidence that a short-term supervised concurrent training program can improve emotional well-being, preserve QOL, and increase adherence to physical activity in breast cancer survivors.

Full description

This randomized, multicenter, parallel-controlled pilot trial was conducted in two tertiary hospitals in Spain to evaluate the effects of a short-term supervised concurrent training program on physical activity adherence and quality of life in breast cancer survivors.

Participants allocated to the intervention group completed a 6-week supervised concurrent training program consisting of 12 sessions (two sessions per week, approximately 60 minutes per session). The training program combined resistance, cardiovascular, and neuromotor exercises and was designed to address muscle strength, cardiorespiratory fitness, coordination, and functional mobility. Exercise sessions were supervised by qualified exercise professionals trained in oncology rehabilitation. Exercise intensity was individually adjusted and monitored to ensure participant safety and adherence to the prescribed training load.

The control group attended a single educational session focused on healthy lifestyle and nutrition and did not participate in the exercise program. Both groups continued to receive usual oncological follow-up throughout the study period.

Assessments were conducted at baseline, immediately after the intervention (6 weeks), and during follow-up at 3 and 6 months to evaluate changes over time. Ethical approval was obtained from the institutional ethics committees of the participating centers (protocol code 2018/0009), and written informed consent was obtained from all participants prior to study participation.

Enrollment

62 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stage I-IIIA
  • Free of disease
  • Without active chemotherapeutic treatment

Exclusion criteria

  • Patients suffered from a chronic disease that prevented them from physical activity program
  • Patients with sequelae of surgery, edema of >2 degrees in extremities with lymphadenectomy
  • Those women who performed PA according to the recommendations established by the WHO.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

62 participants in 2 patient groups

Concurrent Training Program
Experimental group
Description:
This group will participate in a 6-week concurrent training program.
Treatment:
Other: concurrent
Health Education Only (Control)
Active Comparator group
Description:
This group will no participate in the concurrent training intervention program.
Treatment:
Behavioral: Health Education Session

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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