Breast Cancer FemaleNCT03200639
Cachexia in Gynecological Cancer and the Preventive Role of Weight Training
A study testing Combined training and High intensity interval training with body weight in people with Breast Cancer Female and Gynecologic Cancer, run by Universidade Federal do Triangulo Mineiro.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female, Gynecologic Cancer, Menopause
- What is being tested?
- Combined training and High intensity interval training with body weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2015to 10 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postemenopausal women without cancer
- Postemenopausal women with breast cancer
- Postemenopausal women with gynecological cancer
Who cannot join
- No several physical limitations (wheelchair, canes or any similar device)
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer Female, Gynecologic Cancer, Menopause, Physical Activity
- Being tested
- Combined training, High intensity interval training with body weight
- Keywords
- Breast Cancer Female, Gynecologic Cancer, Menopause, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trainingOther
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.
High intensity interval training with body weightOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Other: High intensity interval training with body weight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Secondary outcomes (8)
Citokines
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).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Quality of life
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.
Measured: pre intervention and post intervention (i.e. 12 weeks)
Hormones
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).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Metabolic markers
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).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Electromyography
Quadriceps electromyography
Measured: pre intervention and post intervention (i.e. 12 weeks)
Physical activity level
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.
Measured: pre intervention and post intervention (i.e. 12 weeks)
Nutrition habits
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).
Measured: pre intervention and post intervention (i.e. 12 weeks)
Functional capacity
The activities of daily living was assessed by Lawnton and Katz scale.
Measured: pre intervention and post intervention (i.e. 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start30 May 2015
- Primary completion1 Dec 2015
- Study completion10 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Triangulo Mineiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro
- Investigators
- Fábio Orsatti, PhD, Principal investigator, Federal University of Triângulo Mineiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200639
- Sponsor's protocol ID
- CAAE: 45108115.8.0000.5154
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Al-Majid S, Waters H. The biological mechanisms of cancer-related skeletal muscle wasting: the role of progressive resistance exercise. Biol Res Nurs. 2008 Jul;10(1):7-20. doi: 10.1177/1099800408317345.
PubMed 18705151Bickel CS, Slade J, Mahoney E, Haddad F, Dudley GA, Adams GR. Time course of molecular responses of human skeletal muscle to acute bouts of resistance exercise. J Appl Physiol (1985). 2005 Feb;98(2):482-8. doi: 10.1152/japplphysiol.00895.2004. Epub 2004 Oct 1.
PubMed 15465884Belcastro AN, Shewchuk LD, Raj DA. Exercise-induced muscle injury: a calpain hypothesis. Mol Cell Biochem. 1998 Feb;179(1-2):135-45. doi: 10.1023/a:1006816123601.
PubMed 9543356Campos GE, Luecke TJ, Wendeln HK, Toma K, Hagerman FC, Murray TF, Ragg KE, Ratamess NA, Kraemer WJ, Staron RS. Muscular adaptations in response to three different resistance-training regimens: specificity of repetition maximum training zones. Eur J Appl Physiol. 2002 Nov;88(1-2):50-60. doi: 10.1007/s00421-002-0681-6. Epub 2002 Aug 15.
PubMed 12436270Carson JA, Baltgalvis KA. Interleukin 6 as a key regulator of muscle mass during cachexia. Exerc Sport Sci Rev. 2010 Oct;38(4):168-76. doi: 10.1097/JES.0b013e3181f44f11.
PubMed 20871233Charge SB, Rudnicki MA. Cellular and molecular regulation of muscle regeneration. Physiol Rev. 2004 Jan;84(1):209-38. doi: 10.1152/physrev.00019.2003.
PubMed 14715915Ciechanover A. The ubiquitin-proteasome pathway: on protein death and cell life. EMBO J. 1998 Dec 15;17(24):7151-60. doi: 10.1093/emboj/17.24.7151. No abstract available.
PubMed 9857172Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
PubMed 20392703Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.
PubMed 21760776Eliakim A, Nemet D. Exercise training, physical fitness and the growth hormone-insulin-like growth factor-1 axis and cytokine balance. Med Sport Sci. 2010;55:128-140. doi: 10.1159/000321977. Epub 2010 Oct 14.
PubMed 20956865Farkas J, von Haehling S, Kalantar-Zadeh K, Morley JE, Anker SD, Lainscak M. Cachexia as a major public health problem: frequent, costly, and deadly. J Cachexia Sarcopenia Muscle. 2013 Sep;4(3):173-8. doi: 10.1007/s13539-013-0105-y. Epub 2013 Mar 29.
PubMed 23539127Fluck M, Hoppeler H. Molecular basis of skeletal muscle plasticity--from gene to form and function. Rev Physiol Biochem Pharmacol. 2003;146:159-216. doi: 10.1007/s10254-002-0004-7. Epub 2003 Jan 14.
PubMed 12605307Frystyk J. Exercise and the growth hormone-insulin-like growth factor axis. Med Sci Sports Exerc. 2010 Jan;42(1):58-66. doi: 10.1249/MSS.0b013e3181b07d2d.
PubMed 20010129Glass D, Roubenoff R. Recent advances in the biology and therapy of muscle wasting. Ann N Y Acad Sci. 2010 Nov;1211:25-36. doi: 10.1111/j.1749-6632.2010.05809.x.
PubMed 21062293
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03200639
- Acronym / sponsor ID
- CAAE: 45108115.8.0000.5154
- Conditions
- Breast Cancer Female, Gynecologic Cancer, Menopause, Physical Activity
- Keywords
- Breast Cancer Female, Gynecologic Cancer, Menopause, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universidade Federal do Triangulo MineiroUniversity, hospital or other
- Study start
- 30 May 2015 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 10 Dec 2015 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Physical training, CT | Active comparator | Other: Combined trainingCombined 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) |
| Physical training, HIITBW | Active comparator | Other: High intensity interval training with body weightHigh 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) |
| Physical training, CTc | Experimental | Other: Combined trainingCombined 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) |
| Physical training, HIITBWc | Experimental | Other: High intensity interval training with body weightHigh 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) |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Postemenopausal women without cancer
- Postemenopausal women with breast cancer
- Postemenopausal women with gynecological cancer
Key exclusion criteria (1 listed)
- No several physical limitations (wheelchair, canes or any similar device)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined trainingThe 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. | Other | Physical training, CT, Physical training, CTc |
| High intensity interval training with body weightThe 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. | Other | Physical training, HIITBW, Physical training, HIITBWc |
Primary outcome
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)
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.
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.
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.
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).
8 secondary outcomes
Citokines
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Quality of life
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Hormones
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Metabolic markers
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Electromyography
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Physical activity level
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Nutrition habits
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Functional capacity
Time frame: pre intervention and post intervention (i.e. 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- Background: PubMed 18705151Al-Majid S, Waters H. The biological mechanisms of cancer-related skeletal muscle wasting: the role of progressive resistance exercise. Biol Res Nurs. 2008 Jul;10(1):7-20. doi: 10.1177/1099800408317345.
- Background: PubMed 15465884Bickel CS, Slade J, Mahoney E, Haddad F, Dudley GA, Adams GR. Time course of molecular responses of human skeletal muscle to acute bouts of resistance exercise. J Appl Physiol (1985). 2005 Feb;98(2):482-8. doi: 10.1152/japplphysiol.00895.2004. Epub 2004 Oct 1.
- Background: PubMed 9543356Belcastro AN, Shewchuk LD, Raj DA. Exercise-induced muscle injury: a calpain hypothesis. Mol Cell Biochem. 1998 Feb;179(1-2):135-45. doi: 10.1023/a:1006816123601.
- Background: PubMed 12436270Campos GE, Luecke TJ, Wendeln HK, Toma K, Hagerman FC, Murray TF, Ragg KE, Ratamess NA, Kraemer WJ, Staron RS. Muscular adaptations in response to three different resistance-training regimens: specificity of repetition maximum training zones. Eur J Appl Physiol. 2002 Nov;88(1-2):50-60. doi: 10.1007/s00421-002-0681-6. Epub 2002 Aug 15.
- Background: PubMed 20871233Carson JA, Baltgalvis KA. Interleukin 6 as a key regulator of muscle mass during cachexia. Exerc Sport Sci Rev. 2010 Oct;38(4):168-76. doi: 10.1097/JES.0b013e3181f44f11.
- Background: PubMed 14715915Charge SB, Rudnicki MA. Cellular and molecular regulation of muscle regeneration. Physiol Rev. 2004 Jan;84(1):209-38. doi: 10.1152/physrev.00019.2003.
- Background: PubMed 9857172Ciechanover A. The ubiquitin-proteasome pathway: on protein death and cell life. EMBO J. 1998 Dec 15;17(24):7151-60. doi: 10.1093/emboj/17.24.7151. No abstract available.
- Background: PubMed 20392703Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.
- Background: PubMed 21760776Donohoe CL, Ryan AM, Reynolds JV. Cancer cachexia: mechanisms and clinical implications. Gastroenterol Res Pract. 2011;2011:601434. doi: 10.1155/2011/601434. Epub 2011 Jun 13.
- Background: PubMed 20956865Eliakim A, Nemet D. Exercise training, physical fitness and the growth hormone-insulin-like growth factor-1 axis and cytokine balance. Med Sport Sci. 2010;55:128-140. doi: 10.1159/000321977. Epub 2010 Oct 14.
- Background: PubMed 23539127Farkas J, von Haehling S, Kalantar-Zadeh K, Morley JE, Anker SD, Lainscak M. Cachexia as a major public health problem: frequent, costly, and deadly. J Cachexia Sarcopenia Muscle. 2013 Sep;4(3):173-8. doi: 10.1007/s13539-013-0105-y. Epub 2013 Mar 29.
- Individual participant dataSharing planned: No
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Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fábio Orsatti, PhD principal investigator
Federal University of Triângulo Mineiro
Questions about this trial
What is this clinical trial studying?
A study testing Combined training and High intensity interval training with body weight in people with Breast Cancer Female and Gynecologic Cancer, run by Universidade Federal do Triangulo Mineiro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: pre intervention and post intervention (i.e. 12 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03200639, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.