Back to resultsEffect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.
Primary Purpose
Breast Cancer Survivors, Postmenopause
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Control group
Lower-load resistance training (LL)
Higher-load resistance training (HL)
Higher-volume resistance training (HV)
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer Survivors focused on measuring Breast Cancer Survivors, resistance Training, fatigability, Body Composition, Functional capacity
Eligibility Criteria
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.
Sites / Locations
- Post-degree program in physical educationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Experimental
Experimental
Experimental
Arm Label
Control group, CT
Lower-load resistance training (LL)
Higher-load resistance training (HL)
Higher-volume resistance training (HV)
Arm Description
In the CT, the postmenopausal breast cancer survivers does not perform exercise.
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).
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).
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Four- meter walk test
The volunteers will walk 4 meter. The time will be computed to determine the gait velocity (m/s).
Fat mass
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).
Muscle strength
Muscle strength will be evaluated by one repetition maximum (1RM) test.
Six Minutes-walk test (6MWT)
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.
Timed Up and Go test
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.
Five-times-sit-to-stand test
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).
Muscle mass
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).
10-meter walk test
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.
400-meter walk test
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.
900-meter walk test
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.
Full Information
NCT ID
NCT03644329
First Posted
August 14, 2018
Last Updated
August 21, 2018
Sponsor
Universidade Federal do Triangulo Mineiro
1. Study Identification
Unique Protocol Identification Number
NCT03644329
Brief Title
Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.
Official Title
Effect of Resistance Training Variable Manipulation (Intensity and Volume) on Body Composition, Fatigability and Functional Capacity in Postmenopausal Breast Cancer Survivors.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2018 (Actual)
Primary Completion Date
November 10, 2018 (Anticipated)
Study Completion Date
December 20, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Triangulo Mineiro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors, Postmenopause
Keywords
Breast Cancer Survivors, resistance Training, fatigability, Body Composition, Functional capacity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group, CT
Arm Type
Other
Arm Description
In the CT, the postmenopausal breast cancer survivers does not perform exercise.
Arm Title
Lower-load resistance training (LL)
Arm Type
Experimental
Arm Description
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).
Arm Title
Higher-load resistance training (HL)
Arm Type
Experimental
Arm Description
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).
Arm Title
Higher-volume resistance training (HV)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The volunteers will not performed the interventions.
Intervention Type
Other
Intervention Name(s)
Lower-load resistance training (LL)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Higher-load resistance training (HL)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Higher-volume resistance training (HV)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation the Fatigability
Description
The fatigability will be evaluate by 60 maximum voluntary isometric contractions (3 s contraction, 2 s rest) in knee extensors at 70 degree
Time Frame
pre and post intervention (i.e. 12 weeks)
Secondary Outcome Measure Information:
Title
Four- meter walk test
Description
The volunteers will walk 4 meter. The time will be computed to determine the gait velocity (m/s).
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Fat mass
Description
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).
Time Frame
pre intervention and post intervention (i.e. 12 weeks)
Title
Muscle strength
Description
Muscle strength will be evaluated by one repetition maximum (1RM) test.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Six Minutes-walk test (6MWT)
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Timed Up and Go test
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Five-times-sit-to-stand test
Description
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).
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Muscle mass
Description
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).
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
10-meter walk test
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
400-meter walk test
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
900-meter walk test
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Other Pre-specified Outcome Measures:
Title
Rate of force development (RFD)
Description
RFD will be measured by a rapid maximum isometric voluntary contraction of the one-sidedly knee extension force pulses of right leg.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Electromyography
Description
Quadriceps electromyography
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Physical activity level
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Evaluation the quality of life
Description
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.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Self-report fatigue
Description
The Brief Fatigue Inventory will be used for measured the self-report fatigue.
Time Frame
pre and post intervention (i.e. 12 weeks)
Title
Cytokines
Description
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).
Time Frame
pre and post intervention (i.e. 12 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fábio L Orsatti, PhD
Phone
+55343700-6634
Email
fabiorsatti@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fábio L Orsatti, PhD
Organizational Affiliation
Federal University of Triângulo Mineiro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post-degree program in physical education
City
Uberaba
State/Province
MG - Minas Gerais
ZIP/Postal Code
38061-500
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio L Orsatti, PhD
Phone
+55 34 3700-6634
Email
fabiorsatti@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Resistance Training Variable Manipulation in Postmenopausal Breast Cancer Survivors.
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