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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer Survivors, Postmenopause

Intervention / Treatment
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* Other: Control group
* Other: Lower-load resistance training (LL)
* Other: Higher-load resistance training (HL)
* Other: Higher-volume resistance training (HV)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group, CT<br>In the CT, the postmenopausal breast cancer survivers does not perform exercise. | Other: Control group<br>* The volunteers will not performed the interventions.<br>|
| Experimental: Lower-load resistance training (LL)<br>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)<br>* 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.<br>|
| Experimental: Higher-load resistance training (HL)<br>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)<br>* 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.<br>|
| Experimental: Higher-volume resistance training (HV)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Four- meter walk test | 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 | 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 | Muscle strength will be evaluated by one repetition maximum (1RM) test. | pre and post intervention (i.e. 12 weeks) | 
| 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. | pre and post intervention (i.e. 12 weeks) | 
| 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. | pre and post intervention (i.e. 12 weeks) | 
| 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). | pre and post intervention (i.e. 12 weeks) | 
| 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). | pre and post intervention (i.e. 12 weeks) | 
| 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. | pre and post intervention (i.e. 12 weeks) | 
| 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. | pre and post intervention (i.e. 12 weeks) | 
| 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. | pre and post intervention (i.e. 12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Survivors, resistance Training, fatigability, Body Composition, Functional capacity