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

Not Applicable

Completed

• Conditions: Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage IIIA; Breast Cancer Stage III

• Registration Number: NCT06771635
• Lead Sponsor: Universidad de Burgos

Brief Summary

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.

Detailed Description

Study design and participants

This is a prospective, multicenter, randomized, parallel-controlled pilot study conducted in two Spanish tertiary hospitals. Breast cancer survivors aged 18-65 years, with stage I-IIIA disease, free of active disease, and not undergoing active chemotherapy were eligible. Participants were required to be sedentary or physically inactive according to World Health Organization guidelines. Exclusion criteria included serious comorbidities preventing exercise, postoperative complications, lymphedema grade \>2, or current practice of \>150 minutes of moderate-to-vigorous physical activity per week.

Seventy-eight women were screened, of whom 62 were randomized (intervention group: n=32; control group: n=30). At the 3-month follow-up, 37 participants completed the assessments (intervention: n=15; control: n=22).

Intervention

The intervention consisted of three stages:

Assessment stage

Initial medical and nursing evaluation: clinical history, inclusion/exclusion criteria, anthropometric measurements (weight, height, BMI), and baseline physical activity levels using the Global Physical Activity Questionnaire (GPAQ).

Baseline functional evaluation: handgrip strength with dynamometer, Harvard Step Test, and baseline QOL with the FACT-B questionnaire.

Execution stage

Both groups attended a formative session on healthy lifestyle and nutrition.

The intervention group then completed 12 supervised concurrent training sessions (two 1-hour sessions per week for 6 weeks). Training components included:

Resistance training: circuit format, 8-12 repetitions at 60-80% estimated 1RM, with progressive overload based on baseline strength testing.

Cardiovascular training: treadmill, bicycle, or elliptical at 60-75% estimated maximum heart rate (HRmax = 208.75 - 0.73 × age), lasting 25-50 minutes per session.

Neuromotor training: choreographies with music and stretching, performed at \<60% HRmax.

Participants wore heart rate monitors during all sessions to ensure training safety and adherence to intensity guidelines.

Follow-up stage

Evaluations were performed at 1, 3, and 6 months after the intervention. Questionnaires were completed by mail, telephone, or in-person visits.

Control group

The control group attended only the health education session on lifestyle and nutrition and did not participate in the exercise program. Participants continued to receive standard medical care.

Outcomes

Primary outcome: Quality of life, measured with the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire at baseline, post-intervention (6 weeks), and at 3- and 6-month follow-up.

Secondary outcomes:

Emotional well-being subscale of FACT-B.

Physical activity levels (MET-minutes/week) using the GPAQ.

Sedentary behavior (minutes/day sitting).

Adherence to exercise program (% of sessions attended).

Anthropometric outcomes: BMI, weight, height.

Functional fitness: handgrip strength and Harvard Step Test performance.

Patient satisfaction with the program (Likert survey).

Statistical analysis

Continuous variables are expressed as mean ± standard deviation (SD). Categorical variables are expressed as number and percentage. Statistical analyses were performed with SPSS v28 (IBM Inc., Chicago, IL, USA). A p-value \<0.05 was considered statistically significant.

Normality was assessed using the Kolmogorov-Smirnov test and homoscedasticity with the Levene test. Group comparisons were performed with univariate tests. Repeated-measures ANOVA was used to analyze time × group effects on adherence and QOL outcomes. Effect sizes were calculated using partial eta squared (η²p) and interpreted as: no effect (0-0.05), minimal (0.05-0.26), moderate (0.26-0.64), or strong (≥0.64).

Ethical considerations

The study was conducted in accordance with the Declaration of Helsinki and approved by the appropriate ethics committees. Written informed consent was obtained from all participants before study enrollment.

Study Timeline

• Study Start: 2018-06-11
• Primary Completion: 2019-04-08
• Study Completion: 2019-07-19
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-13
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-29
• Last Update Posted: 2025-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Quality of Life (FACT-B total score)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Quality of life measured with the validated Spanish version of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Includes five subscales: physical, social/family, emotional, functional well-being, and breast cancer concerns. Higher scores indicate better quality of life.

Secondary Outcome Measures

Name	Time	Method
Change in Emotional Well-Being (FACT-B subscale)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Emotional well-being assessed with the FACT-B questionnaire. Higher scores indicate better emotional status.
Change in Physical Activity Level (MET-min/week, GPAQ)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Physical activity levels assessed using the Global Physical Activity Questionnaire (GPAQ). Data expressed in MET-minutes per week across work, transport, and leisure domains.
Mean Sedentary Time (minutes/day, GPAQ)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Sedentary behavior measured using the GPAQ. Time spent sitting or reclining per day is recorded in minutes.
Adherence to Exercise Program (% sessions attended)	During the 6-week intervention period.	Exercise adherence calculated as percentage of supervised sessions attended out of the 12 prescribed sessions.
Change in Weight (kg)	Baseline, post-intervention (6 weeks), 3 months, and 6 months	Body weight measured with a calibrated SECA® scale.
Change in Height (cm)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Height measured with a stadiometer.
Change in Harvard Step Test Score (index units)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Cardiorespiratory fitness assessed with the Harvard Step Test. The fitness index score is calculated as \[exercise duration in seconds × 100\] / \[2 × (sum of heartbeats in recovery periods)\].
Change in Body Mass Index (kg/m²)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Body mass index calculated as weight (kg)/height (m²).
Patient Satisfaction Score (Likert 0-5 scale)	Immediately post-intervention (6 weeks).	Satisfaction with the program assessed using a study-specific survey (0-5 Likert scale) evaluating perceived usefulness, expectations, and adherence intention. Higher scores indicate greater satisfaction.
Change in Handgrip Strength (kg, dynamometer)	Baseline, post-intervention (6 weeks), 3 months, and 6 months.	Handgrip strength measured using a handheld dynamometer, following standardized ACSM protocols.

Trial Locations

Locations (1)

Universidad de Burgos; 🇪🇸 Burgos, Burgos, Spain