Clinical trial · Interventional
Effect of Combined Exercise Post-treatment Intervention in Lean Mass Recovery in Breast Cancer Survival.
Effect of Combined Training Post-treatment Intervention in Lean Body Mass Recovery in Breast Cancer Survival. A Randomised Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer survival it is affected by the side effects related to the illness, the treatments or even the behavioral factors (e.g. inadequate diet, sedentary behavior) that create in this women an important quantity of psychological and physical disorders. Prior systematic reviews and meta-analyses have demonstrate that supervised aerobic training is a safe, feasible, and effective adjunct therapy to improve a broad range of physiological and psychological outcomes in women with early breast cancer. However the vast majority of studies to date have focused on the efficacy of exercise to improve symptom control outcomes in breast cancer patients either during or following the completion of adjuvant therapy. Most relevant consequences are found in women that have to undergo surgery as 16% to 43% of women with breast cancer suffer functional limitation in the shoulder, inflammation, pain or strength and flexibility reduction in upper body limbs one year after surgery with a high prevalence which is rising. Weight gain is associated with decreased quality of life and increased risk for several comorbid conditions, such as cardiovascular disease and diabetes. The most of the cardiopulmonary problems are induced by chemotherapy or radiotherapy, because of the treatments effect in the heart and its consequences in cardiorespiratory fitness of these women. These side effects become in important limitations to allow women return their normal life style. These limitations have a severe effect in decreasing of physical activity practice, which have visible consequences in increasing general fatigue and calcium deficiency in bones due to the age and some adjuvant treatments. Previous studies found that patients with breast cancer who gained modest amounts of weight were significantly more likely to experience disease recurrence and die from breast cancer and other causes that those who were weight stable. In addition, two thirds of the studies that have assessed body composition change in relation to weight gain in this patient population observe no net gain in muscle mass or loss in muscle mass as body weight and adipose tissue increase. These changes are defined as sarcopenic obesity. This kind of obesity is characterized by weight gain in the presence of lean tissue loss or absence of lean tissue gain. In addition fat tissue gain is related with other health disorders such as diabetes, functional limitations and poor survival levels. Treatment for this unique pattern of weight gain is an exercise intervention, especially strength training. Psychological effects have to be took account as cancer produce important aftermath. Large scientific evidence shows the psycho-emotional alterations in women diagnosed with breast cancer at some point in their life. World Health Organization (WHO) defines quality of life as "individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. It is a broad ranging concept affected in a complex way by the person's physical health, psychological state, level of independence, social relationships, personal beliefs and their relationship to salient features of their environment." Following this definition numbered of researches have been developed, presenting interest in both physiological and psychological changes and improvements, as show different studies. HYPOTHESIS The primary hypothesis of this study is that group exercise intervention, combining aerobic and strength training, will reduce lean mass and body fat tissue in breast cancer post treatment survival. Secondary hypothesis of this clinical trial are follows: 1. Combined exercise intervention will increase maximal strength level of chest press and leg press. 2. Combined exercise intervention will increase maximal cardiopulmonary capacity, assessed by Peak Oxygen Consumption(VO2peak), which has been confirmed as an important value in survivals. In addition, ACSM propose this value as the Gold Standard to assess fitness level. 3. Combined exercise intervention will increase global Isometric Strength Index, assessed by Grip Strength Dynamometer. 4. Combined exercise intervention will improve range motion in upper-limbs. 5. Patients Reported Outcomes (PROs), such as quality of life (QoL), Health perception and depression.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiopulmonary Capacity | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Fatigue | — | UNRESOLVED | — |
| Muscle Strength Quantitative Trait Locus 1 | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sarcopenic Obesity in Breast Cancer Survival | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Patients in this group will be asked to maintain the same activity level until the baseline assessments. They cannot change physical activity and nutritional habits.
- type
- EXPERIMENTAL
- label
- Physical Intervention Group
- description
- They have to perform two days per week of guide and planned exercise during three months. All classes are composed by different parts: aerobic exercise, to improve cardiovascular capacity, strength, to work muscle mass and flexibility to increase joint movements. They have to present an attendance above or equal to 80%.
- interventionNames
- Other: Physical Intervention
Primary outcomes (2)
- measure
- Lean mass percentage
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Breast cancer diagnosed confirmed stage I-IIIA. * Randomized disposition. * Minimum of forty-five days and maximum of thirty-six months after finishing treatments (chemotherapy and radiotherapy). * 0-1 in Eastern Cooperative Oncology Group (ECOG) scale (present the ability to walk briskly) * Oncologist approval. * Informed Consent signed. * Community of Madrid inhabitant. Exclusion Criteria: * Metastasis presence * Serious medical risk such as unstable cardiac condition or severe pulmonary disease and anticoagulants treatments. * Oncology or primary care approval who verified the medical risk exclusion criteria. * ECOG \> 1 * Pregnant
References
Publications (26)
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- BACKGROUNDSchmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvao DA, Pinto BM, Irwin ML, Wolin KY, Segal RJ, Lucia A, Schneider CM, von Gruenigen VE, Schwartz AL; American College of Sports Medicine. American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010 Jul;42(7):1409-26. doi: 10.1249/MSS.0b013e3181e0c112. PMID 20559064
- BACKGROUNDSpeck RM, Courneya KS, Masse LC, Duval S, Schmitz KH. An update of controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. J Cancer Surviv. 2010 Jun;4(2):87-100. doi: 10.1007/s11764-009-0110-5. Epub 2010 Jan 6. PMID 20052559
- BACKGROUNDLakoski SG, Eves ND, Douglas PS, Jones LW. Exercise rehabilitation in patients with cancer. Nat Rev Clin Oncol. 2012 Mar 6;9(5):288-96. doi: 10.1038/nrclinonc.2012.27. PMID 22392097
- BACKGROUNDSagen A, Karesen R, Risberg MA. Physical activity for the affected limb and arm lymphedema after breast cancer surgery. A prospective, randomized controlled trial with two years follow-up. Acta Oncol. 2009;48(8):1102-10. doi: 10.3109/02841860903061683.