Breast Cancer
Conditions
Keywords
resistance training, muscular strength, health-related quality of life, exercise intensity, breast malignancy
Brief 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.
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.
Interventions
BEHAVIORALDaily 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.
BEHAVIORALTraining intensity prescription based on an initial 1RM estimation using load-velocity relationship
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.
BEHAVIORALTraditional 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.
Sponsors
Universidad de Almeria
Patronato Municipal de Deportes de Almería, Spain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscular strength | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Handgrip strength | Change from baseline to week 8 | Handgrip strength will be determined using a digital dynamometer (Model T.K.K.540; Takei Scientific Instruments Co, Ltd). |
| Muscle function (5STS) | Change from baseline to week 8 | 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. |
| Height (scale) | Baseline | Height will be determined using a scale (cm) |
| Body weight (InBody 770) | Change from baseline to week 8 | Body wieght (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). |
| Total fat mass (InBody 770) | Change from baseline to week 8 | Total fat mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). |
| Fat percentage (InBody 770) | Change from baseline to week 8 | body fat percentage (%) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). |
| Fat-free mass (InBody) | Change from baseline to week 8 | Fat-free mass (kg) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). |
| Visceral fat mass level (InBody) | Change from baseline to week 8 | Visceral fat mass level (U) will be determined using bioelectrical impedance analysis (InBody 770; InBody Co Ltd, Seoul, Korea). |
| Health-related quality of life (FACT-B) | Change from baseline to week 8 | 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. |
| Cancer-related fatigue (FACIT-F) | Change from baseline to week 8 | 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. |
| Anxiety and depression (HADS) | Change from baseline to week 8 | 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. |
| Patient global impression of change | Week 8 | Patient global impression of change after the intervention will be evaluated at the end of the trial using a single Likert-type question. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORAlberto Soriano-Maldonado
Universidad de Almeria
Outcome results
None listed