Clinical trial NCT03200639: Cachexia in Gynecological Cancer and the Preventive Role of Weight Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Gynecologic Cancer
Menopause
Physical Activity
Keywords: Breast Cancer Female
Gynecologic Cancer
Menopause
Physical Activity
Lead sponsor: Universidade Federal do Triangulo Mineiro
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 38
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Body composition
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Muscle strength
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Rate of force development (a critical component of muscle power)
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Cardiorespiratory fitness
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Short physical performance battery (SPPB)
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
Secondary outcomes:
measure: Citokines
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Quality of life
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Hormones
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Metabolic markers
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Electromyography
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Physical activity level
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Nutrition habits
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
measure: Functional capacity
timeFrame: pre intervention and post intervention (i.e. 12 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Triângulo Mineiro
name: Fábio Orsatti, PhD
role: PRINCIPAL_INVESTIGATOR
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