Breast Cancer Stage INCT06771635
Effect of Physical Training Program on the Exercise Adherence for Breast Cancer Survivor
A study testing concurrent and Health Education Session in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Universidad de Burgos at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- concurrent and Health Education Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 11 Jun 2018to 19 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-IIIA
- Free of disease
- Without active chemotherapeutic treatment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Targeted Concurrent Training Program on the Exercise Adherence in Female Breast Cancer Survivors: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- concurrent, Health Education Session
- Keywords
- Breast Cancer, Physical activity, Adherence, Concurrent training
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concurrentOther
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 SessionBehavioural
Single formative session on healthy lifestyle and nutrition provided to both groups. Control group received only this session without concurrent training.
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Training Program | Experimental | This group will participate in a 6-week concurrent training program. Receives: Other: concurrent |
| Health Education Only (Control) | Active comparator | This group will no participate in the concurrent training intervention program. Receives: Behavioral: Health Education Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Emotional well-being assessed using the Emotional Well-Being subscale of the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The subscale score ranges from 0 to 24 points, with higher scores indicating better emotional well-being.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Physical Activity Level (MET-min/week, GPAQ)
Physical activity levels assessed using the Global Physical Activity Questionnaire (GPAQ). Data expressed in MET-minutes per week across work, transport, and leisure domains.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Mean Sedentary Time (minutes/day, GPAQ)
Sedentary behavior measured using the GPAQ. Time spent sitting or reclining per day is recorded in minutes.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Adherence to Exercise Program (percent of sessions attended)
Exercise adherence calculated as the percent of supervised exercise sessions attended out of the 12 prescribed sessions during the intervention period
Measured: During the 6-week intervention period.
Change in Weight (kg)
Body weight measured with a calibrated SECA® scale.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months
Change in Height (cm)
Height measured with a stadiometer.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Body Mass Index (kg/m²)
Body mass index calculated as weight (kg)/height (m²).
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Handgrip Strength (kg, dynamometer)
Handgrip strength measured using a handheld dynamometer, following standardized ACSM protocols.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Cardiorespiratory Fitness (Harvard Step Test Fitness Index)
Cardiorespiratory fitness assessed using the Harvard Step Test Fitness Index, which typically ranges from 0 to 150 units, with higher scores indicating better cardiorespiratory fitness.
Measured: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Patient Satisfaction with the Intervention (Study-Specific Satisfaction Questionnaire)
Patient satisfaction assessed using a study-specific satisfaction questionnaire scored on a 0 to 5 Likert scale, where 0 indicates very dissatisfied and 5 indicates very satisfied. Higher scores indicate greater satisfaction.
Measured: Immediately post-intervention (6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start11 Jun 2018
- Primary completion8 Apr 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Stage IStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Is a prospective, multicenter, randomized, parallel-controlled, prospective pilot study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Instituto Valenciano de Oncología, Fundación Trinidad Alfonso
- Responsible party
- Sponsor
- Investigators
- Juan Mielgo-Ayuso, PhD, Study director, Universidad de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771635
- Sponsor's protocol ID
- 2018/0009
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only IPD used in the results publication
Publications
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.
PubMed 34989765Weiner 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.
PubMed 31144265Friedenreich 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.
PubMed 18487249
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Targeted Concurrent Training Program on the Exercise Adherence in Female Breast Cancer Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06771635
- Acronym / sponsor ID
- 2018/0009
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Collaborators
- Fundación Instituto Valenciano de Oncología, Fundación Trinidad Alfonso
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Is a prospective, multicenter, randomized, parallel-controlled, prospective pilot study
| Arm | Type | Receives |
|---|---|---|
| Concurrent Training Program | Experimental | Other: concurrentThis group will participate in a 6-week concurrent training program. |
| Health Education Only (Control) | Active comparator | Behavioral: Health Education SessionThis group will no participate in the concurrent training intervention program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage I-IIIA
- Free of disease
- Without active chemotherapeutic treatment
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| concurrentThe 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 | Other | Concurrent Training Program |
| Health Education SessionSingle formative session on healthy lifestyle and nutrition provided to both groups. Control group received only this session without concurrent training. | Behavioural | Health Education Only (Control) |
Primary outcome
Change in Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B] Total Score)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
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.
10 secondary outcomes
Change in Emotional Well-Being (Functional Assessment of Cancer Therapy-Breast Emotional Well-Being Subscale)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Physical Activity Level (MET-min/week, GPAQ)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Mean Sedentary Time (minutes/day, GPAQ)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Adherence to Exercise Program (percent of sessions attended)
Time frame: During the 6-week intervention period.
Change in Weight (kg)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months
Change in Height (cm)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Body Mass Index (kg/m²)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Handgrip Strength (kg, dynamometer)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Change in Cardiorespiratory Fitness (Harvard Step Test Fitness Index)
Time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Patient Satisfaction with the Intervention (Study-Specific Satisfaction Questionnaire)
Time frame: Immediately post-intervention (6 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Results publication: PubMed 34989765Cao 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.
- Results publication: PubMed 31144265Weiner 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.
- Results publication: PubMed 18487249Friedenreich 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.
- Individual participant dataSharing planned: No. Only IPD used in the results publication
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Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Mielgo-Ayuso, PhD study director
Universidad de Burgos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing concurrent and Health Education Session in people with Breast Cancer Stage I and Breast Cancer Stage II, run by Universidad de Burgos at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B] Total Score) (time frame: Baseline, post-intervention (6 weeks), 3 months, and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771635, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.