Cachexia in Gynecological Cancer and the Preventive Role of Weight Training

June 23, 2017 updated by: Fábio Lera Orsatti, Universidade Federal do Triangulo Mineiro

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)
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).
pre intervention and post intervention (i.e. 12 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)
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).
pre intervention and post intervention (i.e. 12 weeks)
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).
pre intervention and post intervention (i.e. 12 weeks)
Electromyography
Time Frame: pre intervention and post intervention (i.e. 12 weeks)
Quadriceps electromyography
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)
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).
pre intervention and post intervention (i.e. 12 weeks)
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.
pre intervention and post intervention (i.e. 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Federal do Triangulo Mineiro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fábio Orsatti, PhD, Federal University of Triângulo Mineiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAE: 45108115.8.0000.5154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gynecologic Cancer

Clinical Trials on Combined training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings