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

NCT ID: NCT06771635

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-11
• Study Completion Date: 2019-07-19

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Concurrent Training Program

This group will participate in a 6-week concurrent training program.

Group Type: EXPERIMENTAL

concurrent

Intervention Type: OTHER

The concurrent training program is divided into three types of training: endurance, cardiovascular and neuromotor.

Resistance training sessions were performed in a circuit format with >30" rest periods between exercises. The volume of work ranged from 8 to 12 repetitions at 60% of the estimated 1 maximum repetition (RM).

The cardiovascular work time per session ranged from 25-50 min depending on the intensity of the exercise and the intensity was regulated according to the maximum heart rate (FHR) estimated for each subject between 60-75%

The neuromotor training intensity of the sessions was low. The participants wore a heart rate monitor and were instructed not to exceed 60% of their HRF

Health Education Only (Control)

This group will no participate in the concurrent training intervention program.

Group Type: ACTIVE_COMPARATOR

Health Education Session

Intervention Type: BEHAVIORAL

Single formative session on healthy lifestyle and nutrition provided to both groups. Control group received only this session without concurrent training.

Interventions

concurrent

The concurrent training program is divided into three types of training: endurance, cardiovascular and neuromotor.

Resistance training sessions were performed in a circuit format with >30" rest periods between exercises. The volume of work ranged from 8 to 12 repetitions at 60% of the estimated 1 maximum repetition (RM).

The cardiovascular work time per session ranged from 25-50 min depending on the intensity of the exercise and the intensity was regulated according to the maximum heart rate (FHR) estimated for each subject between 60-75%

The neuromotor training intensity of the sessions was low. The participants wore a heart rate monitor and were instructed not to exceed 60% of their HRF

Intervention Type: OTHER

Health Education Session

Single formative session on healthy lifestyle and nutrition provided to both groups. Control group received only this session without concurrent training.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación Instituto Valenciano de Oncología

OTHER

Sponsor Role: collaborator

Fundación Trinidad Alfonso

UNKNOWN

Sponsor Role: collaborator

Universidad de Burgos

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Mielgo-Ayuso, PhD

Role: STUDY_DIRECTOR

Universidad de Burgos

Locations

Universidad de Burgos

Burgos, Burgos, Spain

Countries

Spain

References

Cao C, Friedenreich CM, Yang L. Association of Daily Sitting Time and Leisure-Time Physical Activity With Survival Among US Cancer Survivors. JAMA Oncol. 2022 Mar 1;8(3):395-403. doi: 10.1001/jamaoncol.2021.6590.

Reference Type: RESULT

PMID: 34989765 (View on PubMed)

Weiner LS, Takemoto M, Godbole S, Nelson SH, Natarajan L, Sears DD, Hartman SJ. Breast cancer survivors reduce accelerometer-measured sedentary time in an exercise intervention. J Cancer Surviv. 2019 Jun;13(3):468-476. doi: 10.1007/s11764-019-00768-8. Epub 2019 May 29.

Reference Type: RESULT

PMID: 31144265 (View on PubMed)

Friedenreich CM, Cust AE. Physical activity and breast cancer risk: impact of timing, type and dose of activity and population subgroup effects. Br J Sports Med. 2008 Aug;42(8):636-47. doi: 10.1136/bjsm.2006.029132. Epub 2008 May 16.

Reference Type: RESULT

PMID: 18487249 (View on PubMed)

Other Identifiers

2018/0009

Identifier Type: -

Identifier Source: org_study_id