NCT03644329

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

August 14, 2018

Last Update Submit

August 21, 2018

Conditions

Breast Cancer SurvivorsPostmenopause

Keywords

Breast Cancer Survivorsresistance TrainingfatigabilityBody CompositionFunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Evaluation the Fatigability

    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 Outcomes (10)

  • Four- meter walk test

    pre and post intervention (i.e. 12 weeks)

  • Fat mass

    pre intervention and post intervention (i.e. 12 weeks)

  • Muscle strength

    pre and post intervention (i.e. 12 weeks)

  • Six Minutes-walk test (6MWT)

    pre and post intervention (i.e. 12 weeks)

  • Timed Up and Go test

    pre and post intervention (i.e. 12 weeks)

  • +5 more secondary outcomes

Other Outcomes (6)

  • Rate of force development (RFD)

    pre and post intervention (i.e. 12 weeks)

  • Electromyography

    pre and post intervention (i.e. 12 weeks)

  • Physical activity level

    pre and post intervention (i.e. 12 weeks)

  • +3 more other outcomes

Study Arms (4)

Control group, CT

OTHER

In the CT, the postmenopausal breast cancer survivers does not perform exercise.

Other: Control group

Lower-load resistance training (LL)

EXPERIMENTAL

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)

Higher-load resistance training (HL)

EXPERIMENTAL

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)

Higher-volume resistance training (HV)

EXPERIMENTAL

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)

Interventions

Control groupOTHER

The volunteers will not performed the interventions.

Control group, CT
Lower-load resistance training (LL)OTHER

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.

Lower-load resistance training (LL)
Higher-load resistance training (HL)OTHER

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.

Higher-load resistance training (HL)
Higher-volume resistance training (HV)OTHER

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.

Higher-volume resistance training (HV)

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post-degree program in physical education

Uberaba, MG - Minas Gerais, 38061-500, Brazil

RECRUITING

Related Publications (58)

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MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Fábio L Orsatti, PhD

    Federal University of Triângulo Mineiro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fábio L Orsatti, PhD

CONTACT

+55343700-6634fabiorsatti@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 23, 2018

Study Start

May 13, 2018

Primary Completion

November 10, 2018

Study Completion

December 20, 2019

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)