Effect of Combined Exercise Post-treatment Intervention in Lean Mass Recovery in Breast Cancer Survival.

Summary

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

• Sarcopenic Obesity in Breast Cancer Survival
• Muscle Strength Quantitative Trait Locus 1
• Cardiopulmonary Capacity
• Quality of Life
• Fatigue
• Depression

Interventions

OTHER

Physical Intervention

The exercise program will be designed and conducted by qualified in Physical Activity and Sport Sciences. The exercise program will consist in a combined two days per week of supervised training program and one day per week of briskly walking by themselves, following a document, designed by the specialist trainer, which will be given at the beginning of the program. The intervention will have a duration of 12 consecutive weeks. The intensity will be increasing progressively from 65% to 85% of heart rate. The intensity will be controlled by heart rate monitor trademark POLAR FT7 in aerobic exercise and with the number of repetitions (from 8 to 15) and sets (from 2 to 3) in strength exercises. Prescription intensity will be done using Karvonen equation, recommended method to work with risk population.

Sponsors & Collaborators

• Universidad Politecnica de Madrid

  lead OTHER

Principal Investigators

• Javier Sampedro, Professor · Universidad Politecnica de Madrid

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2014-06-30

Completion

2014-09-30

Countries

• Spain

Study Locations