Breast CancerNCT06940310
Different Resistance Training Intensity Prescription and Monitoring Methodologies: Effects on Strength, Body Composition, and Well-being in Survivors of Breast Cancer
A study testing Daily load-velocity-based training intensity adjustment., Training intensity prescription based on an initial 1RM estimation using load-velocity relationship and Traditional training with intensity prescription based on 1RM testing. in people with Breast Cancer, run by Universidad de Almeria at 1 site in Spain.
Trial summary
The goal of this clinical trial is to compare the effects of three different methods of prescribing and monitoring resistance training intensity on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Daily load-velocity-based training intensity adjustment., Training intensity prescription based on an initial 1RM estimation using load-velocity relationship and Traditional training with intensity prescription based on 1RM testing.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 9 May 2025to 19 Dec 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be >18 years old.
- To have a breast cancer diagnosis.
- To have finished chemotherapy, radiotherapy and/or surgery up to 10 years prior to the beginning of the study.
Who cannot join
- To present metastatic breast cancer.
- To have a planned surgery for breast reconstruction within three months after the start of the study.
- To present any absolute contraindication for exercising.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Methods of Prescription and Monitoring of Resistance Training Intensity on Muscle Strength, Body Composition, and Psychological Well-being in Survivors of Breast Cancer
The goal of this clinical trial is to compare the effects of three different methods of prescribing and monitoring resistance training intensity on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors.
Read the detailed description
Breast cancer survival rates have significantly increased in recent years, highlighting the importance of effective interventions to address the long-term consequences of cancer and its treatments. Breast cancer survivors often experience muscle weakness, changes in body composition, fatigue, and psychological distress, which can negatively impact their quality of life. Resistance training has been widely recognized as a safe and effective strategy to counteract these effects, improving muscle strength, body composition, and psychological well-being.
Despite its benefits, the optimal method for prescribing and monitoring resistance training intensity in breast cancer survivors remains unclear. Traditional methods based on one-repetition maximum (1RM) testing may not fully account for individual variations in fatigue and performance. Alternative approaches, such as load-velocity relationships, allow for more precise and real-time adjustments to training intensity, potentially optimizing outcomes.
This randomized controlled trial aims to compare the effects of three different methods of resistance training intensity prescription and monitoring on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors. The findings will contribute to developing evidence-based exercise guidelines, enhancing rehabilitation strategies and overall well-being in this population.
- Conditions
- Breast Cancer
- Being tested
- Daily load-velocity-based training intensity adjustment., Training intensity prescription based on an initial 1RM estimation using load-velocity relationship, Traditional training with intensity prescription based on 1RM testing.
- Keywords
- resistance training, muscular strength, health-related quality of life, exercise intensity, breast malignancy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily load-velocity-based training intensity adjustment.Behavioural
At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity.
Training intensity prescription based on an initial 1RM estimation using load-velocity relationshipBehavioural
In the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention.
Traditional training with intensity prescription based on 1RM testing.Behavioural
The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Daily load-velocity-based training intensity adjustment | Experimental | At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity. Receives: Behavioral: Daily load-velocity-based training intensity adjustment. |
| Training intensity prescription based on an initial 1RM estimation using load-velocity relationship. | Experimental | In the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention. Receives: Behavioral: Training intensity prescription based on an initial 1RM estimation using load-velocity relationship |
| Traditional training with intensity prescription based on 1RM testing. | Experimental | The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention. Receives: Behavioral: Traditional training with intensity prescription based on 1RM testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscular strength
The main variable of the present study will be muscle strength, assessed by determining peak isometric strength in the bench press and squat exercises using force platforms.
Measured: Change from baseline to week 8
Secondary outcomes (12)
Handgrip strength
Handgrip strength will be determined using a digital dynamometer (Model T.K.K.540; Takei Scientific Instruments Co, Ltd).
Measured: Change from baseline to week 8
Muscle function (5STS)
Muscle function will be assessed using the 30-second sit-to-stand test. Additionally, the five-repetition sit-to-stand (5STS) test will be performed on force platforms, and the peak force of all repetitions will be recorded.
Measured: Change from baseline to week 8
Height (scale)
Height will be determined using a scale (cm)
Measured: Baseline
Body weight (InBody 770)
Body wieght (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Measured: Change from baseline to week 8
Total fat mass (InBody 770)
Total fat mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Measured: Change from baseline to week 8
Fat percentage (InBody 770)
body fat percentage (%) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Measured: Change from baseline to week 8
Fat-free mass (InBody)
Fat-free mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Measured: Change from baseline to week 8
Visceral fat mass level (InBody)
Visceral fat mass level (U) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea).
Measured: Change from baseline to week 8
Health-related quality of life (FACT-B)
Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The global score ranges from 0 to 148 where higher scores indicate better quality of life.
Measured: Change from baseline to week 8
Cancer-related fatigue (FACIT-F)
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire. The score ranges from 0 to 52, where higher scores indicate lower levels of fatigue.
Measured: Change from baseline to week 8
Anxiety and depression (HADS)
Anxiety and depression will be determined using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for both HADS-A (Anxiety) and HADS-D (Depression) subscales, where higher scores indicate more severe symptoms of anxiety or depression.
Measured: Change from baseline to week 8
Patient global impression of change
Patient global impression of change after the intervention will be evaluated at the end of the trial using a single Likert-type question.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start9 May 2025
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Almeria
- Sponsor type
- University, hospital or other
- Collaborators
- Patronato Municipal de Deportes de Almería, Spain
- Responsible party
- Principal investigator, Alberto Soriano-Maldonado, Universidad de Almeria
- Investigators
- Alberto Soriano-Maldonado, Principal investigator, Universidad de Almeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940310
- Sponsor's protocol ID
- EFICAN/04/2025
- Status last verified
- May 2026
- First submitted
- 28 Mar 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data will be shared once the study is finalized and the main results are published. IPD can be obtained by contacting the responsible party.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Methods of Prescription and Monitoring of Resistance Training Intensity on Muscle Strength, Body Composition, and Psychological Well-being in Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT06940310
- Acronym / sponsor ID
- EFICAN/04/2025
- Conditions
- Breast Cancer
- Keywords
- resistance training, muscular strength, health-related quality of life, exercise intensity, breast malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universidad de AlmeriaUniversity, hospital or other
- Collaborators
- Patronato Municipal de Deportes de Almería, Spain
- Study start
- 9 May 2025 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 23 Apr 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.
The goal of this clinical trial is to compare the effects of three different methods of prescribing and monitoring resistance training intensity on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors.
Detailed description
Breast cancer survival rates have significantly increased in recent years, highlighting the importance of effective interventions to address the long-term consequences of cancer and its treatments. Breast cancer survivors often experience muscle weakness, changes in body composition, fatigue, and psychological distress, which can negatively impact their quality of life. Resistance training has been widely recognized as a safe and effective strategy to counteract these effects, improving muscle strength, body composition, and psychological well-being.
Despite its benefits, the optimal method for prescribing and monitoring resistance training intensity in breast cancer survivors remains unclear. Traditional methods based on one-repetition maximum (1RM) testing may not fully account for individual variations in fatigue and performance. Alternative approaches, such as load-velocity relationships, allow for more precise and real-time adjustments to training intensity, potentially optimizing outcomes.
This randomized controlled trial aims to compare the effects of three different methods of resistance training intensity prescription and monitoring on muscle strength, body composition, quality of life, fatigue, anxiety, and depression in breast cancer survivors. The findings will contribute to developing evidence-based exercise guidelines, enhancing rehabilitation strategies and overall well-being in this population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Daily load-velocity-based training intensity adjustment | Experimental | Behavioral: Daily load-velocity-based training intensity adjustment.At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity. |
| Training intensity prescription based on an initial 1RM estimation using load-velocity relationship. | Experimental | Behavioral: Training intensity prescription based on an initial 1RM estimation using load-velocity relationshipIn the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention. |
| Traditional training with intensity prescription based on 1RM testing. | Experimental | Behavioral: Traditional training with intensity prescription based on 1RM testing.The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- To be >18 years old.
- To have a breast cancer diagnosis.
- To have finished chemotherapy, radiotherapy and/or surgery up to 10 years prior to the beginning of the study.
Key exclusion criteria (3 listed)
- To present metastatic breast cancer.
- To have a planned surgery for breast reconstruction within three months after the start of the study.
- To present any absolute contraindication for exercising.
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 |
|---|---|---|
| Daily load-velocity-based training intensity adjustment.At the beginning of the training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. Additionally, during the training sessions, intensity will be monitored, and load will be adjusted in real time by movement velocity. | Behavioural | Daily load-velocity-based training intensity adjustment |
| Training intensity prescription based on an initial 1RM estimation using load-velocity relationshipIn the first training session, the one-repetition maximum (1RM) will be estimated based on the individual's load-velocity relationship, using the general velocity associated with the 1RM for the exercises included in the session. This 1RM will be used to prescribe exercise intensity throughout the intervention. | Behavioural | Training intensity prescription based on an initial 1RM estimation using load-velocity relationship. |
| Traditional training with intensity prescription based on 1RM testing.The traditional training group will follow a training program using the traditionally employed methodology for assessing and prescribing training intensity in breast cancer survivors. This methodology is based on an initial 1RM estimation conducted through a 1RM test, which will be used to prescribe the training load throughout the intervention. | Behavioural | Traditional training with intensity prescription based on 1RM testing. |
Primary outcome
Muscular strength
Time frame: Change from baseline to week 8
The main variable of the present study will be muscle strength, assessed by determining peak isometric strength in the bench press and squat exercises using force platforms.
12 secondary outcomes
Handgrip strength
Time frame: Change from baseline to week 8
Muscle function (5STS)
Time frame: Change from baseline to week 8
Height (scale)
Time frame: Baseline
Body weight (InBody 770)
Time frame: Change from baseline to week 8
Total fat mass (InBody 770)
Time frame: Change from baseline to week 8
Fat percentage (InBody 770)
Time frame: Change from baseline to week 8
Fat-free mass (InBody)
Time frame: Change from baseline to week 8
Visceral fat mass level (InBody)
Time frame: Change from baseline to week 8
Health-related quality of life (FACT-B)
Time frame: Change from baseline to week 8
Cancer-related fatigue (FACIT-F)
Time frame: Change from baseline to week 8
Anxiety and depression (HADS)
Time frame: Change from baseline to week 8
Patient global impression of change
Time frame: Week 8
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 29 May 2026.
- Individual participant dataSharing planned: Yes. All individual participant data will be shared once the study is finalized and the main results are published. IPD can be obtained by contacting the responsible party.
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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.
Alberto Soriano-Maldonado principal investigator
Universidad de Almeria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily load-velocity-based training intensity adjustment., Training intensity prescription based on an initial 1RM estimation using load-velocity relationship and Traditional training with intensity prescription based on 1RM testing. in people with Breast Cancer, run by Universidad de Almeria 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 29 May 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?
Muscular strength (time frame: Change from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.