Depression Clinical Trial
— WIM1Official title:
Effect of Combined Training Post-treatment Intervention in Lean Body Mass Recovery in Breast Cancer Survival. A Randomised Controlled Trial.
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.
Status | Unknown status |
Enrollment | 90 |
Est. completion date | September 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Physical Activity and Sport Science Faculty | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Politecnica de Madrid |
Spain,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lean mass percentage | Lean body mass percentage in each participant before and after intervention in intervention group and three months after in control group, assessed by bioimpedance. | 3 months | |
Primary | Maximal Strength | Maximal strength in upper limbs and in legs assessed by 8 RM protocol. Maxima resistance strength. | 3 months | |
Secondary | Fat body mass | Percentage of body mass assessed by bio-impedance | 3 months | |
Secondary | Cardiovascular capacity | Submaximal cardiovascular capacity assessed by modified bruce protocol to 85% of maximal hearth rate. | 3 months | |
Secondary | Quality of Life | Quality of Life level assessed by FACT-B Questionnaire. Each dimension will be analyzed separately. | 3 moths | |
Secondary | Fatigue | Facit.org specific questionnaire will be used. | 3 months | |
Secondary | Health Perception | SF-36 questionnaire will be used. | 3 months | |
Secondary | Depression | CES-D questionnaire will be used and 16 will be the limit to define a depressive attitude. | 3 months | |
Secondary | Leisure-time exercise | It is the quantity of exercise that post treatment women do in them leisure-time and it is assessed by Godin Leisure-Time Exercise Questionnaire. | 3 months |
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