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

NCT06771635 | Completed DMC

• 1 other identifier: 2018/0009
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast Cancer; Physical activity; Adherence; Concurrent training

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B] Total Score)

  Quality of life assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B total score ranges from 0 to 148 points, with higher scores indicating better quality of life.

  Baseline, post-intervention (6 weeks), 3 months, and 6 months.

Secondary Outcomes (10)

• Change in Emotional Well-Being (Functional Assessment of Cancer Therapy-Breast Emotional Well-Being Subscale)

  Baseline, post-intervention (6 weeks), 3 months, and 6 months.

• Change in Physical Activity Level (MET-min/week, GPAQ)

  Baseline, post-intervention (6 weeks), 3 months, and 6 months.

• Mean Sedentary Time (minutes/day, GPAQ)

  Baseline, post-intervention (6 weeks), 3 months, and 6 months.

• Adherence to Exercise Program (percent of sessions attended)

  During the 6-week intervention period.

• Change in Weight (kg)

  Baseline, post-intervention (6 weeks), 3 months, and 6 months

Study Arms (2)

Concurrent Training Program

EXPERIMENTAL

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

Other: concurrent

Health Education Only (Control)

ACTIVE COMPARATOR

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

Behavioral: Health Education Session

Interventions

concurrent 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

Concurrent Training Program

Health Education Session BEHAVIORAL

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

Health Education Only (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Burgos: lead
• Fundación Instituto Valenciano de Oncología: collaborator
• Fundación Trinidad Alfonso: collaborator

Study Sites (1)

Universidad de Burgos

Burgos, Burgos, 09001, Spain

Location

Related Publications (3)

• 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.

  PMID: 34989765 RESULT

• 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.

  PMID: 31144265 RESULT

• 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.

  PMID: 18487249 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Juan Mielgo-Ayuso, PhD

  Universidad de Burgos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Is a prospective, multicenter, randomized, parallel-controlled, prospective pilot study

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: June 11, 2018
• Primary Completion: April 8, 2019
• Study Completion: July 19, 2019
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)