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Cachexia in Gynecological Cancer and the Preventive Role of Weight Training

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ClinicalTrials.gov Identifier: NCT03200639
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Gynecologic Cancer Menopause Physical Activity Other: Combined training Other: High intensity interval training with body weight Not Applicable

Detailed Description:

Physical training has been recommended to prevent or attenuation cachexia and sarcopenia in older people with or without cancer. The American College of Sports Medicine recommends 150 min of moderate intensity exercise combining aerobic exercise with resistance exercises, termed as combined training (CT). However, it has been reported that very low proportion (<10%) of older adults meet the physical activity recommendation. Lack of time has been reported as a common reason to people not to do exercise. Thus, identifying effective physical training dosages and modalities which may be feasible are necessary for this population.

Repeated brief bouts of fast and intense exercise interspersed with low intensity exercise termed as high intensity interval training (HIIT) has shown to be a time-effective strategy to improve cardiorespiratory fitness in young and older. Moreover, HIIT has shown to improve glycemic control in patients at high risk for TDM2, muscle mass, body fat and physical function. However, there were many pending issues involving the HIIT for sarcopenia and cachexia in older people. For instance, the lack of access to physical activity facilities, such as the need for specific equipment (i.e. fitness equipment: treadmill, bike or resistance exercise equipment) and the need for high motor skill levels to performance the high-intensity exercise (i.e. run at high speed) have been reported as another reason to older people not to do HIIT.

Different HIIT programs performed outside of laboratory has been proposed, especially with body-weight exercises. The high-intensity interval body weight training (HIBWT) is performed without equipment and with low motor skill levels. HIBWT has been shown to improve fat mass, muscle mass, cardiorespiratory capacity and physical performance in young adults with or without overweight. Despite this, no previous studies have evaluated HIBWT efficacy and safe in older people with sarcopenia and cachexia. The study aim was to compare the effectiveness of CT and 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of High Intensity Interval Body Weight Training Versus Combined Training on Body Composition, Physical Function, Metabolic Risk and Inflammation in Postmenopausal Women With and Without Gynecological Cancer
Actual Study Start Date : May 30, 2015
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 10, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Physical training, CT
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
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.

Active Comparator: Physical training, HIITBW
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
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.

Experimental: Physical training, CTc
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
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.

Experimental: Physical training, HIITBWc
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
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.




Primary Outcome Measures :
  1. Body composition [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    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)

  2. Muscle strength [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    It was measured by the one repetition maximum (1RM) test in the leg extension equipment.

  3. Rate of force development (a critical component of muscle power) [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    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.

  4. Cardiorespiratory fitness [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    The six-minute walk test and the one mile walk test was performed indoor, on a flat floor in a sports court.

  5. Short physical performance battery (SPPB) [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]

    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).



Secondary Outcome Measures :
  1. Citokines [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]

    Blood samples (16 ml) were collected between 7:30 AM and 9:00 AM after an overnight fast (10-12 hours). The blood samples (venous) were collected by a dry tube with gel separator or EDTA (vacuum-sealed system; Vacutainer, England). The sample was centrifuged for 10 minutes (3.000 rpm) and samples were separated and stocked (-80 C) for futures analysis.

    The blood indicators were measured as follows: IL-10, IL-6, IL-1ra, TNF-α, ICAM-1, MCP-1, Leptin and Total Adiponectin (enzyme-linked immunosorbent assay method) with Readwell Touch equipment (Robonik, India) and R&D kits (USA).


  2. Quality of life [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    Quality of life - The 36-Item Short Form Health Survey (SF-36) was used to measure the overall quality of life aspects, separated in the following domains: functional capacity, physical limitations, pain, overall health, vitality, social aspects, emotional limitations and mental health.

  3. Hormones [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]

    Blood samples (16 ml) were collected between 7:30 AM and 9:00 AM after an overnight fast (10-12 hours). The blood samples (venous) were collected by a dry tube with gel separator or EDTA (vacuum-sealed system; Vacutainer, England). The sample was centrifuged for 10 minutes (3.000 rpm) and samples were separated and stocked (-80 C) for futures analysis.

    The blood indicators were measured as follows: Testosterone, LH, TSH, T4, insulin, DHEA-S, E2 and FSH (electrochemoluminescence method).


  4. Metabolic markers [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]

    Blood samples (16 ml) were collected between 7:30 AM and 9:00 AM after an overnight fast (10-12 hours). The blood samples (venous) were collected by a dry tube with gel separator or EDTA (vacuum-sealed system; Vacutainer, England). The sample was centrifuged for 10 minutes (3.000 rpm) and samples were separated and stocked (-80 C) for futures analysis.

    The blood indicators were measured as follows: Glucose, C-reactive protein, Hb1Ac (automated colorimetric method), total cholesterol, ALT and AST (kinetic method) with Cobas 6000 equipment and Roche kit (USA).


  5. Electromyography [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    Quadriceps electromyography

  6. Physical activity level [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    The International Physical Activity Questionnaire (IPAQ) was used to measure the level (time spent) of physical activities of light, moderate and high intensities during the day. Also, the sitting time (minutes) per day was measured.

  7. Nutrition habits [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    A three-day food record (two days in the middle of week and one on the weekend) was used to determine the energy and macronutrients (carbohydrates, proteins and fats).

  8. Functional capacity [ Time Frame: pre intervention and post intervention (i.e. 12 weeks) ]
    The activities of daily living was assessed by Lawnton and Katz scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200639


Sponsors and Collaborators
Universidade Federal do Triangulo Mineiro
Investigators
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Principal Investigator: Fábio Orsatti, PhD Federal University of Triângulo Mineiro
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fábio Lera Orsatti, Professor, PhD, Universidade Federal do Triangulo Mineiro
ClinicalTrials.gov Identifier: NCT03200639    
Other Study ID Numbers: CAAE: 45108115.8.0000.5154
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro:
Breast Cancer Female
Gynecologic Cancer
Menopause
Physical Activity