Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.

August 21, 2018 updated by: Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro

Effect of Resistance Training Variable Manipulation (Intensity and Volume) on Body Composition, Fatigability and Functional Capacity in Postmenopausal Breast Cancer Survivors.

This study intends to evaluate the impact of resistance training variable manipulation (intensity and volume) on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The treatment for breast cancer (chemotherapy, radiotherapy and hormone therapy) provokes collateral effects,such as muscle mass and strength losses, increase of fat mass, fatigue and disability and reduced quality of life in postmenopausal breast cancer survivors. The resistance training is assumed as a non-pharmacologic interventions in postmenopausal breast cancer survivors. However, it is unclear whether the manipulation of training variables (intensity and volume) maximize the effects of resistance training on body composition, fatigability and functional capacity in postmenopausal breast cancer survivors.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • MG - Minas Gerais
      • Uberaba, MG - Minas Gerais, Brazil, 38061-500
        • Recruiting
        • Post-degree program in physical education
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Postmenopausal breast cancer survivors;
  • No supervised or unsupervised exercise at least for six months prior to the study.

Exclusion Criteria:

  • Alcoholics;
  • No controlled blood pressure and glucose;
  • Presence of myopathies, arthropathies, and neuropathies;
  • Presence of muscle, thromboembolic and gastrointestinal disorders, infection diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group, CT
In the CT, the postmenopausal breast cancer survivers does not perform exercise.
Other: Control group
The volunteers will not performed the interventions.
Experimental: Lower-load resistance training (LL)
In the LL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with low loads ( i.e. three sets with 30% of one-repetition maximum).
Other: Lower-load resistance training (LL)
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 30% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
Experimental: Higher-load resistance training (HL)
In the HL, the postmenopausal breast cancer survivers will be submitted to 12 weeks of resistance training with high loads (i.e. three sets with 80% of one maximum repetition).
Other: Higher-load resistance training (HL)
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
Experimental: Higher-volume resistance training (HV)
In the HV, the postmenopause breast cancer survivers will be submitted to 12 weeks of resistance training with high volume ( i.e. six sets with 80% one maximum repetition).
Other: Higher-volume resistance training (HV)
The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, six sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation the Fatigability
Time Frame: pre and post intervention (i.e. 12 weeks)
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree
pre and post intervention (i.e. 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Four- meter walk test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will walk 4 meter. The time will be computed to determine the gait velocity (m/s).
pre and post intervention (i.e. 12 weeks)
Fat mass
Time Frame: pre intervention and post intervention (i.e. 12 weeks)
The fat mass (kg) will be assessed via dual-energy x-ray absorptiometry scanning (iDXA; GE Healthcare-Luna, Madison, WI; software Encore version 14.10).
pre intervention and post intervention (i.e. 12 weeks)
Muscle strength
Time Frame: pre and post intervention (i.e. 12 weeks)
Muscle strength will be evaluated by one repetition maximum (1RM) test.
pre and post intervention (i.e. 12 weeks)
Six Minutes-walk test (6MWT)
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will walk 6 minutes. The distance (meters) will be recorded after completes the test. The 6MWT will be performed indoor, on a flat floor in a sports court.
pre and post intervention (i.e. 12 weeks)
Timed Up and Go test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will be advised to get up from a chair, walk three meters, turn around, go back to the chair, and sit down. The time (seconds) will be recorded. The test will be performed indoor, on a flat floor in a sports court.
pre and post intervention (i.e. 12 weeks)
Five-times-sit-to-stand test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will rise from a chair and returned to the seated position as quickly as possible for five repetitions. The time will be recorded (seconds).
pre and post intervention (i.e. 12 weeks)
Muscle mass
Time Frame: pre and post intervention (i.e. 12 weeks)
The muscle mass (kg) will be assessed via dual-energy x-ray absorptiometry scanning (iDXA; GE Healthcare-Luna, Madison, WI; software Encore version 14.10).
pre and post intervention (i.e. 12 weeks)
10-meter walk test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will walk 10 meters. The gait speed will be evaluated (m/s). The test will be performed indoor, on a flat floor in a sports court.
pre and post intervention (i.e. 12 weeks)
400-meter walk test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will walk 400 meters. The gait speed will be evaluated (m/s). The test will be performed indoor, on a flat floor in a sports court.
pre and post intervention (i.e. 12 weeks)
900-meter walk test
Time Frame: pre and post intervention (i.e. 12 weeks)
The volunteers will walk 900 meters. The gait speed will be evaluate (m/s). The test will be performed indoor, on a flat floor in a sports court.
pre and post intervention (i.e. 12 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of force development (RFD)
Time Frame: pre and post intervention (i.e. 12 weeks)
RFD will be measured by a rapid maximum isometric voluntary contraction of the one-sidedly knee extension force pulses of right leg.
pre and post intervention (i.e. 12 weeks)
Electromyography
Time Frame: pre and post intervention (i.e. 12 weeks)
Quadriceps electromyography
pre and post intervention (i.e. 12 weeks)
Physical activity level
Time Frame: pre and post intervention (i.e. 12 weeks)
The International Physical Activity Questionnaire short form (IPAQ) will be used to measure the level (time spent) of physical activities during the day. The questionnaire records the activity of four intensity levels: 1) vigorous-intensity activity such as aerobics, 2) moderate-intensity activity such as leisure cycling, 3) walking, and 4) sitting. The level of physical activity will be quantified by the sum of the four levels of intensity.
pre and post intervention (i.e. 12 weeks)
Evaluation the quality of life
Time Frame: pre and post intervention (i.e. 12 weeks)
The 36-Item Short Form Health Survey (SF-36) will be used to measure the overall quality of life aspects in the following domains: functional capacity, physical limitations, pain, overall health, vitality, social aspects, emotional limitations and mental health.
pre and post intervention (i.e. 12 weeks)
Self-report fatigue
Time Frame: pre and post intervention (i.e. 12 weeks)
The Brief Fatigue Inventory will be used for measured the self-report fatigue.
pre and post intervention (i.e. 12 weeks)
Cytokines
Time Frame: pre and post intervention (i.e. 12 weeks)
Blood samples (16 ml) will be collected between 7:30 AM and 9:00 AM after an overnight fast (10-12 hours). The blood samples (venous) will be collected by a dry tube with gel separator or EDTA (vacuum-sealed system; Vacutainer, England). The sample will be centrifuged for 10 minutes (3.000 rpm) and samples will be separated and stocked (-80 C) for futures analysis. The blood indicators will be measured (enzyme-linked immunosorbent assay method) with Touch equipment and R&D kits (USA).
pre and post intervention (i.e. 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Triangulo Mineiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2018

Primary Completion (Anticipated)

November 10, 2018

Study Completion (Anticipated)

December 20, 2019

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 82691818.0.0000.5154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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