Effect of Combined Exercise Post-treatment Intervention in Lean Mass Recovery in Breast Cancer Survival. (WIM1)

This study is currently recruiting participants.
Verified November 2013 by Universidad Politecnica de Madrid
Sponsor:
Information provided by (Responsible Party):
Soraya Casla Barrio, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier:
NCT01843608
First received: April 26, 2013
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention
Sarcopenic Obesity in Breast Cancer Survival
Muscle Strength Quantitative Trait Locus 1
Cardiopulmonary Capacity
Quality of Life
Fatigue
Depression
Other: Physical Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Combined Training Post-treatment Intervention in Lean Body Mass Recovery in Breast Cancer Survival. A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Universidad Politecnica de Madrid:

Primary Outcome Measures:
  • Lean mass percentage [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Lean body mass percentage in each participant before and after intervention in intervention group and three months after in control group, assessed by bioimpedance.

  • Maximal Strength [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Maximal strength in upper limbs and in legs assessed by 8 RM protocol. Maxima resistance strength.


Secondary Outcome Measures:
  • Fat body mass [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Percentage of body mass assessed by bio-impedance

  • Cardiovascular capacity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Submaximal cardiovascular capacity assessed by modified bruce protocol to 85% of maximal hearth rate.

  • Quality of Life [ Time Frame: 3 moths ] [ Designated as safety issue: Yes ]
    Quality of Life level assessed by FACT-B Questionnaire. Each dimension will be analyzed separately.

  • Fatigue [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Facit.org specific questionnaire will be used.

  • Health Perception [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    SF-36 questionnaire will be used.

  • Depression [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    CES-D questionnaire will be used and 16 will be the limit to define a depressive attitude.

  • Leisure-time exercise [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 90
Study Start Date: February 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group

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.

Experimental: Physical Intervention Group

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%.

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.
Other Name: Women In Motion

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  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843608

Contacts
Contact: Soraya Casla, PhD Student +34 91336 ext 4081 soraya.casla@upm.es
Contact: Ruben O Barakat, Profesor +34 91336 ext 4020 rubenomar.barakat@upm.es

Locations
Spain
Physical Activity and Sport Science Faculty Recruiting
Madrid, Spain, 28040
Contact: Soraya Casla, PhD Student    +34 91334 ext 4081    soraya.casla@upm.es   
Sub-Investigator: Ruben O Barakat, Profesor         
Principal Investigator: Soraya Casla, PhD Student         
Sponsors and Collaborators
Universidad Politecnica de Madrid
Investigators
Study Director: Javier Sampedro, Professor Universidad Politécnica de Madrid
  More Information

Additional Information:
Publications:

Responsible Party: Soraya Casla Barrio, PhD Student, Universidad Politecnica de Madrid
ClinicalTrials.gov Identifier: NCT01843608     History of Changes
Other Study ID Numbers: MSMSCCMYEJ1
Study First Received: April 26, 2013
Last Updated: November 22, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Universidad Politecnica de Madrid:
Physical treatment
Exercise prescription to breast cancer survival
Side cancer effect treatment

Additional relevant MeSH terms:
Breast Neoplasms
Depression
Depressive Disorder
Fatigue
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight

ClinicalTrials.gov processed this record on April 17, 2014