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

Postmenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03644329
• Other study ID #: CAAE: 82691818.0.0000.5154
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: August 2018
• Source: Universidade Federal do Triangulo Mineiro
• Contact: Fábio L Orsatti, PhD
• Phone: +55343700-6634
• Email: fabiorsatti[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 20, 2019
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Postmenopause

Intervention

Other:
• Control group
The volunteers will not performed the interventions.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Post-degree program in physical education	Uberaba	MG - Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Triangulo Mineiro

Country where clinical trial is conducted

Brazil, 

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of force development (RFD)	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)
Other	Electromyography	Quadriceps electromyography	pre and post intervention (i.e. 12 weeks)
Other	Physical activity level	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)
Other	Evaluation the quality of life	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)
Other	Self-report fatigue	The Brief Fatigue Inventory will be used for measured the self-report fatigue.	pre and post intervention (i.e. 12 weeks)
Other	Cytokines	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)
Primary	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	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)
Secondary	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)
Secondary	Muscle strength	Muscle strength will be evaluated by one repetition maximum (1RM) test.	pre and post intervention (i.e. 12 weeks)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)