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| Name | Class |
|---|---|
| Patronato Municipal de Deportes de AlmerÃa, Spain | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily load-velocity-based training intensity adjustment. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Handgrip strength | Handgrip strength will be determined using a digital dynamometer (Model T.K.K.540; Takei Scientific Instruments Co, Ltd). | Change from baseline to week 8 |
| Muscle function (5STS) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of perceived exertion (RPE) | The rate of perceived exertion during the whole training session will be assessed at the end of each of the 24 intervention session using the modified Borg Scale (0-10) where higher scores mean higher perceived exertion. | Through intervention completion, during 8 weeks. From day 1 to day 24. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alberto Soriano-Maldonado | Universidad de Almeria | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Almeria | AlmerÃa | Almeria | 04120 | Spain |
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.
One year (12 months) after study completion and once the results have been published.
The PI must be contacted and a consensus must be reached on potential co-authorship.
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|
| Training intensity prescription based on an initial 1RM estimation using load-velocity relationship | Behavioral | 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. | Behavioral | 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. |
|
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.
| Change from baseline to week 8 |
| Height (scale) | Height will be determined using a scale (cm) | Baseline |
| Body weight (InBody 770) | Body wieght (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). | 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). | 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). | 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). | 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). | 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. | 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. | 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. | 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. | Week 8 |
| Mood (Feeling Scale) |
The mood perceived by the participants at the end of the session will be measured at the end of each of the 24 intervention session using the Feeling Scale. The scale ranges from -5 to 5, where higher scores indicate positive affect toward physical activity. |
| Through intervention completion, during 8 weeks. From day 1 to day 24. |
| Perceived fatigue (VAS-F) | The fatigue perceived by the participants at the end of the session will be assessed at the end of each of the 24 intervention session using a visual analog scale for fatigue (VAS-F). The scale ranges from 0 to 10, where higher scores indicate greater fatigue. | Through intervention completion, during 8 weeks. From day 1 to day 24. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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