Cachexia in Gynecological Cancer and the Preventive Role of Weight Training

NCT03200639 | Completed

• 1 other identifier: CAAE: 45108115.8.0000.5154
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aim was to compare the effectiveness of combined training (CT; aerobic + resistance exercises) and high-intensity interval body weight training (HIITBW) on body composition, metabolic and inflammatory profile, physical function and quality of life in older women with gynecological and breast cancer and their pair-matched controls (older women with no cancer). The hypothesis of the present clinical trial is that HIITBW is effective as well as CT for improvements on body composition, metabolic and inflammatory profile, physical function and quality of life in older women with gynecological and breast cancer.

Conditions

Breast Cancer Female; Gynecologic Cancer; Menopause; Physical Activity

Keywords

Breast Cancer Female; Gynecologic Cancer; Menopause; Physical Activity

Outcome Measures

Primary Outcomes (5)

• Body composition

  Soft-tissue (fat mass, kg and lean mass, kg) of whole body and regional composition were 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

  It was measured by the one repetition maximum (1RM) test in the leg extension equipment.

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

• Rate of force development (a critical component of muscle power)

  It was measured by a rapid maximum isometric voluntary contraction of the one-sidedly knee extension force pulses (Metrolog SD20-LVDT, São Carlos/SP, Brazil) of both legs.

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

• Cardiorespiratory fitness

  The six-minute walk test and the one mile walk test was performed indoor, on a flat floor in a sports court.

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

• Short physical performance battery (SPPB)

  The SPPB consisted of three tests performed in the following order: balance test, four-meter walk test, and five-time-sit-to-stand test. Each test score varied to zero to four points, and the SPPB total score varied to zero to 12 points (sum of the scores of the three tests).

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

Secondary Outcomes (8)

• Citokines

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

• Quality of life

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

• Hormones

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

• Metabolic markers

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

• Electromyography

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

Study Arms (4)

Physical training, CT

ACTIVE COMPARATOR

Combined Trained with no cancer (CT): Post menopausal women with no cancer submitted to 12 weeks of combined training (i.e. aerobic training plus resistance training)

Other: Combined training

Physical training, HIITBW

ACTIVE COMPARATOR

High intensity interval training with body weight with no cancer (HIITBW): Post menopausal women with no cancer submitted to 12 weeks of high intensity interval training with body weight (i.e. step climbing plus squats)

Other: High intensity interval training with body weight

Physical training, CTc

EXPERIMENTAL

Combined Trained with gynecological and/or breast cancer (CTc): Post menopausal women with with gynecological and/or breast cancer submitted to 12 weeks of combined training (i.e. aerobic training plus resistance training)

Other: Combined training

Physical training, HIITBWc

EXPERIMENTAL

High intensity interval training with body weight with gynecological and/or breast cancer (HIITBWc): Post menopausal women with gynecological and/or breast cancer submitted to 12 weeks of high intensity interval training with body weight (i.e. step climbing plus squats)

Other: High intensity interval training with body weight

Interventions

Combined training OTHER

The CT and CTc protocol (total length time \~60 min) were performed three times a week for 12 weeks, in nonconsecutive days, and were composed by 30-min walk at 70% of maximum heart rate or Borg Scale at 5-6 following resistance exercises (RE: 45-degree half squat, bench press, leg curl, rowing machine and unilateral leg extension) at 70% of one repetition maximum (1RM) with three sets of 8-12 repetitions and 1.5 min rest interval between sets and exercises. If the volunteer exceeded or did not reach the walk intensity, the volunteer was stimulated by to decrease or increase the walk speed, respectively. Regarding the resistance exercises, the load was adjusted in the 6th week with the 1RM test to ensure the 70% of 1RM between 8-12 repetitions.

Physical training, CT; Physical training, CTc

High intensity interval training with body weight OTHER

The HIITBW and HIITBWc protocol (total length time \~28 min) were performed three times a week for 12 weeks, in nonconsecutive days, and were composed by ten sets of 60 s of high (vigorous) intensity exercises at 80-95% of HRmax or Borg Scale at 8-9 (i.e. 30s of stepping up and down on a step and 30s of squatting up and down as fast as possible) interspersed with a recovery of 60 s of light walk (\<60% of HRmax or Borg Scale at \<5). To ensure vigorous zone of all sets, if the volunteer exceeded or did not reach the vigorous zone the volunteer was stimulated by the fitness professionals to decrease or increase the number of steps and squats, respectively.

Physical training, HIITBW; Physical training, HIITBWc

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postemenopausal women without cancer
• Postemenopausal women with breast cancer
• Postemenopausal women with gynecological cancer

You may not qualify if:

• No several physical limitations (wheelchair, canes or any similar device)

Sponsors & Collaborators

• Universidade Federal do Triangulo Mineiro: lead

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• Limirio LS, Rossato LT, Barbosa CD, Teixeira KRC, Nahas PC, de Branco FMS, Martins FM, Nomelini RS, Murta EFC, Orsatti FL, de Oliveira EP. Body Mass Index, waist circumference or sagittal abdominal diameter: Which parameter is better correlated with body fat changes in postmenopausal women after combined training protocol? Clin Nutr ESPEN. 2020 Aug;38:192-195. doi: 10.1016/j.clnesp.2020.05.004. Epub 2020 May 30.

  PMID: 32690157 DERIVED

• Nunes PRP, Martins FM, Souza AP, Carneiro MAS, Nomelini RS, Michelin MA, Murta EFC, de Oliveira EP, Orsatti FL. Comparative effects of high-intensity interval training with combined training on physical function markers in obese postmenopausal women: a randomized controlled trial. Menopause. 2019 Nov;26(11):1242-1249. doi: 10.1097/GME.0000000000001399.

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• Martins FM, de Paula Souza A, Nunes PRP, Michelin MA, Murta EFC, Resende EAMR, de Oliveira EP, Orsatti FL. High-intensity body weight training is comparable to combined training in changes in muscle mass, physical performance, inflammatory markers and metabolic health in postmenopausal women at high risk for type 2 diabetes mellitus: A randomized controlled clinical trial. Exp Gerontol. 2018 Jul 1;107:108-115. doi: 10.1016/j.exger.2018.02.016. Epub 2018 Feb 19.

  PMID: 29471132 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training; Weights and Measures

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• Fábio Orsatti, PhD

  Federal University of Triângulo Mineiro

  PRINCIPAL INVESTIGATOR

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: Professor, PhD

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 27, 2017
• Study Start: May 30, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 10, 2015
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share