Combined Training Intervention for Women Who Underwent Primary Treatment for Breast Cancer

NCT03124095 | Completed DMC

• 1 other identifier: +Vida-Breast cancer
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is analyze the effects of combined training program (resistance and aerobics) in comparison with a non-training group on quality of life, as well as on neuromuscular and cardiorespiratory parameters in breast cancer patients in stages one to three who have finished their treatment, such as surgery, chemotherapy and radiotherapy. Therefore, 42 women will be randomly divided into two groups: combined training group and control group. The subjects of the combined training group will undergo the intervention three times a week for eight weeks. The combined group will carry out both resistance and aerobic exercises in the same session. The resistance training will be comprised by ten exercises which will alternate body segments with maximum repetitions in the first set and the lower limit of the repetitions interval in the next sets. Along the training, the number of series will be increased whereas the number of repetitions will be decreased. The intensity of the aerobic exercises will be based on the percentage of the heart rate of the anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic threshold on the last weeks. Before and after the intervention, there will be evaluation of maximal dynamic strength of knee extensors and elbow flexors, maximum voluntary isometric contraction of knee extensors, maximum muscular activity of vastus lateralis and rectus femoris, muscle thickness of knee extensors, peak oxygen uptake and ventilatory threshold, quality of life and cancer-related fatigue. Data will be analyzed by Generalized Estimating Equations (GEE) and Bonferroni's post-hoc (α=0,05), including both protocol and intention to treat.

Conditions

Breast Neoplasm

Keywords

physical exercise; combined training; physical activity; physical fitness

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness evaluation change after 8 weeks

  We created a protocol on the treadmill to determine the peak oxygen uptake change(VO2peak), the first ventilatory threshold and the second ventilatory threshold. The protocol consists in 1-minute stages. The initial speed is 1.86 miles per hour. In each stage, the speed increases 0.3 miles per hour and every 2 stages, the treadmill inclination increases 1%. The test is interrupted when the subject indicates exhaustion. The respiratory gases will be collected through a portable gas analyzer (VO2000, MedGraphics, Ann Arbor, USA). The maximum value of VO2 , closed to exhaustion will be considered the VO2peak. The fist and the second ventilatory threshold will be determined by the ventilation versus intensity curve and confirmed by the O2 and Carbon dioxide ventilatory equivalents by two independent physiologists in a visual inspection.

  Testing of VO2peak change - Baseline and 8 week

Secondary Outcomes (6)

• Quality of Life change after 8 weeks (Score)

  Baseline and 8 week

• Maximal dynamic strength change after 8 weeks (kg)

  Baseline and 8 week

• maximum voluntary isometric contraction of knee extensors change after 8 weeks

  Baseline and 8 week

• Cancer related fatigue change after 8 weeks

  Baseline and 8 week

• muscle thickness of knee extensors change after 8 weeks

  Baseline and 8 week

Study Arms (2)

Combined Exercise Group

EXPERIMENTAL

The subjects of the combined training group will undergo the intervention three times a week for eight weeks. The combined group will carry out both resistance and aerobic exercises in the same session. The resistance training will be comprised by ten exercises which will alternate body segments with maximum repetitions in the first set and the lower limit of the repetitions interval in the next sets. Along the training, the number of series will be increased whereas the number of repetitions will be decreased. The intensity of the aerobic exercises will be based on the percentage of the heart rate of the anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic threshold on the last weeks

Behavioral: Combined exercise Group

Control Group

NO INTERVENTION

The control group will be advised not to change their health habits. After the intervention they will be invited to participate in a physical exercise program.

Interventions

Combined exercise Group BEHAVIORAL

The subjects of the combined training group will undergo the intervention three times a week for eight weeks. The combined group will carry out both resistance and aerobic exercises in the same session. The resistance training will be comprised by ten exercises which will alternate body segments with maximum repetitions in the first set and the lower limit of the repetitions interval in the next sets. Along the training, the number of series will be increased whereas the number of repetitions will be decreased. The intensity of the aerobic exercises will be based on the percentage of the heart rate of the anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic threshold on the last weeks

Combined Exercise Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer women above 18 years old with histological confirmed breast cancer in stages I-IIIA who have finished their treatment, such as surgery, chemotherapy and radiotherapy.

You may not qualify if:

• Cardiovascular disease (except hypertension controlled by medication);
• Metastatic disease or active regional locus;
• Physical or psychiatric impairments for exercise;
• Severe nausea;
• Anorexia;
• Participation in exercise more than 75 minutes/week

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Physical Education School

Pelotas, Rio Grande do Sul, 96055-630, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 21, 2017
• Study Start: September 1, 2016
• Primary Completion: November 26, 2017
• Study Completion: December 31, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

BR (1)