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

Sponsor

Universidade Federal do Triangulo Mineiro (Other)

Overall Status

Unknown status

CT.gov ID

NCT03644329

Collaborator

(none)

Enrollment

Location

Arms

19.3

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Survivors Postmenopause	Other: Control group Other: Lower-load resistance training (LL) Other: Higher-load resistance training (HL) Other: Higher-volume resistance training (HV)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 13, 2018

Anticipated Primary Completion Date :

Nov 10, 2018

Anticipated Study Completion Date :

Dec 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Evaluation the Fatigability [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

Secondary Outcome Measures

Four- meter walk test [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).
Fat mass [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).
Muscle strength [pre and post intervention (i.e. 12 weeks)]
Muscle strength will be evaluated by one repetition maximum (1RM) test.
Six Minutes-walk test (6MWT) [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.
Timed Up and Go test [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.
Five-times-sit-to-stand test [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).
Muscle mass [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).
10-meter walk test [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.
400-meter walk test [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.
900-meter walk test [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.

Other Outcome Measures

Rate of force development (RFD) [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.
Electromyography [pre and post intervention (i.e. 12 weeks)]
Quadriceps electromyography
Physical activity level [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.
Evaluation the quality of life [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.
Self-report fatigue [pre and post intervention (i.e. 12 weeks)]
The Brief Fatigue Inventory will be used for measured the self-report fatigue.
Cytokines [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.