Sarcopenic ObesityNCT03370211
Resistance Training and Sarcopenic Obesity Elderly Women
A study testing resistance training in people with Sarcopenic Obesity and Inflammation, run by Universidade Estadual de Londrina.
Trial summary
In this manuscript, we investigated the effect of resistance training (RT) on body composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic obesity elderly women, using a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity, Inflammation, Functional Capacity
- What is being tested?
- resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years old or more;
- presented sarcopenic obesity SO [which was defined by the simultaneous presence of sarcopenia and obesity (Batsis et al., 2015; Studenski et al., 2014), whereas women were considered sarcopenic if appendicular lean soft tissue (LST) <15.02 kg, and obese if percentage of body fat ≥ 35% (Batsis et al., 2015)];
- physically independent;
- free from cardiac or orthopedic dysfunction;
- not receiving hormonal replacement and/or thyroid therapy;
- not using equipment that would compromise the accomplishment of protocols and tests;
- not performing any regular physical exercise more than once a week over the six months preceding the beginning of the investigation.
Who cannot join
- individuals with any metallic implant or artificial pacemaker, who had undergone surgery, who were unable to perform the tests and trainings;
- volunteers who failed the medical examination for any reason;
- refused or were unable to give consent.
About this study
Official title: Effect of Resistance Training on Body Composition, Functional Capacity, Inflammatory and Oxidative Stress Biomarkers in Sarcopenic Obesity Elderly Women: a Randomized Controlled Trial
In this manuscript, we investigated the effect of resistance training (RT) on body composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic obesity elderly women, using a randomized controlled trial.
Read the detailed description
To investigate the effects of resistance training (RT) program on body composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic obesity elderly women. This study is a randomized controlled trial. Thirty-seven sarcopenic obesity (SO) elderly women were randomly allocated into two groups: a training group (TG, n=18) or a non-exercising control group (CG, n=19). A supervised RT program was performed by TG for 12 weeks and CG did not perform any type of physical exercise during this period. Body composition (DXA), functional capacity [(muscular strength, and the 10 m walk test (10MW), and rising from sitting position test (RSP)] and blood sample measurements (after a 12 h fasting) were performed pre- and post-training. The investigation was carried out over a period of 16 weeks, with 12 weeks dedicated to the RT program and 4 weeks allocated for measurements. Anthropometric, muscular strength, body composition, and blood samples measurements were performed at weeks 1-2, and 15-16. A supervised progressive RT was performed between weeks 3-14. The CG did not perform any type of physical exercise during this period. However, given the possible positive effects of exercise, elderly women of this group were incorporated into a new exercise program after the end of this experiment. Data distribution was tested using the Shapiro Wilk test. Descriptive statistics are presented as means and standard deviations. Student's independent t-test and chi-square test were used to compare the control and intervention groups regarding the general characteristics and clinical conditions (categorical variables), respectively. Two-way analysis of covariance (ANCOVA) for repeated measures was applied for comparisons, with baseline scores used as covariates. When F-ratio was significant, Bonferroni's post hoc test was employed to identify the mean differences. Between group effect size (ES) was calculated to verify magnitude of the difference between groups. The Z-score of the percentage changes (from pre- to post-training) of the raw data for each parameter was calculated, and a total Z-score, derived from the all components was calculated. To verify the differences among groups on total Z-scores, a test T independent also was applied. For all statistical analyses, significance was accepted at P< 0.05. The data were analyzed using STATISTICA software version 13.2 (Statsoft Inc., Tulsa, OK, USA).
- Conditions
- Sarcopenic Obesity, Inflammation, Functional Capacity
- Being tested
- resistance training
- Keywords
- resistance training, inflammatory markers, functional capacity
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingOther
Participants from TG performed program, executed in 3 sets of 10-15RM, 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was composed of 8 exercises comprising one exercise with free weights and seven with machines performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. All participants were personally supervised by physical education professionals with substantial RT experience to help ensure consistent and safe exercise performance. Participants were instructed to inhale during the eccentric phase and exhale during the concentric phase while maintaining a constant velocity of movement at a ratio of approximately 1:2 seconds (concentric and eccentric phases, respectively). Participants were afforded 1 to 2 min of rest between sets and 2 to 3 min between each exercise. The average duration of each session lasted approximately 50-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| experimental intervention | Experimental | The training group performed the resistance training (RT) program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, wirh 3 sets of 10-15 repetition maximums (RM).The RT program was performed in the following order: chest press, seated row, triceps pushdown, preacher curl, horizontal leg press, knee extension, leg curl, , and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise. Receives: Other: resistance training |
| control group | No intervention | The control group did not perform any type of physical exercise during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body composition
To assess total and appendicular lean soft-tissue (LST), and total body fat (in kg), whole-body dual-energy X-ray absorptiometry DXA (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) was used.
Measured: baseline and 12 weeks
Change in muscular strength
Functional capacity was evaluated using measures of muscular strength (total strength) by 1RM test assessed in the chest press (CP), knee extension (KE), and preacher curl (PC) exercises, performed in this exact order.The 1RM was recorded as the final load lifted in which the subject was able to complete only one single maximal execution. Total strength was determined by the sum of the 3 exercises and express in Kg.
Measured: baseline and 12 weeks
Change in inflammatory biomarkers
Measurements of tumor necrosis factor alpha (TNF-α), and Interluekin-6 (IL-6), were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R\&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). The results are presented in picograms per milliliter (pg/ml). All samples were determined in duplicate to guarantee the precision of the results.
Measured: baseline and 12 weeks
Change in oxidative stress biomarkers
For the oxidative stress measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method described by Witko-Sarsat et al. (Witko-Sarsat et al., 1996). AOPP concentrations are expressed as micromoles per liter (μmol/L) of chloramines-T equivalents.
Measured: baseline and 12 weeks
Change in functional capacity
Functional capacity was evaluated using measures of muscular strength (total strength), the 10-m walk test (10MW) and rising from sitting position test (RSP) express in (s). For the 10MW test older women were required to walk the distance of 10 m rapidly to evaluate the displacement speed; for the RSP, they were required to get up and sit down from a chair five times consecutively. In both tests the timer was triggered after the command "start now". At the moment the task was completed the timer was stopped.
Measured: baseline and 12 weeks
Change in insulin-like growth factor 1 (IGF-1)
The concentrations of insulin-like growth factor 1 (IGF-1), were obtained in a specialized laboratory by a chemiluminescence method using a Liaison XL Immunoassay Analyzer (DiaSorin S.p.A, Saluggia, Italy). The values are expressed in (µU/mL)
Measured: baseline and 12 weeks
Secondary outcomes (2)
Change in C-reative protein (CRP)
Measurements of serum levels of high-sensitivity CRP were carried out using a biochemical auto-analyzer system (Dimension RxL Max - Siemens Dade Behring) according to established methods in the literature consistent with the manufacturer's recommendations. The results are presented in milligram/liter (mg/L)
Measured: baseline and 12 weeks
Changes in Anthropometry Parameters
Body mass was measured to the nearest 0.1 kg using a calibrated electronic scale (Balmak, Laboratory Equipment Labstore, Curitiba, Paraná, Brazil), with the participants wearing light workout clothing and no shoes. Height was measured with a stadiometer attached to the scale to the nearest 0.1 cm, with subjects standing without shoes. Body mass index was calculated as body mass in kilograms divided by the square of height in meters.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study startMar 2015
- Primary completionJul 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crisieli Maria Tomeleri, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370211
- Sponsor's protocol ID
- UELGEP2017
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training on Body Composition, Functional Capacity, Inflammatory and Oxidative Stress Biomarkers in Sarcopenic Obesity Elderly Women: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03370211
- Acronym / sponsor ID
- UELGEP2017
- Conditions
- Sarcopenic Obesity, Inflammation, Functional Capacity
- Keywords
- resistance training, inflammatory markers, functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 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.
In this manuscript, we investigated the effect of resistance training (RT) on body composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic obesity elderly women, using a randomized controlled trial.
Detailed description
To investigate the effects of resistance training (RT) program on body composition, functional capacity, inflammatory and oxidative stress biomarkers in sarcopenic obesity elderly women. This study is a randomized controlled trial. Thirty-seven sarcopenic obesity (SO) elderly women were randomly allocated into two groups: a training group (TG, n=18) or a non-exercising control group (CG, n=19). A supervised RT program was performed by TG for 12 weeks and CG did not perform any type of physical exercise during this period. Body composition (DXA), functional capacity [(muscular strength, and the 10 m walk test (10MW), and rising from sitting position test (RSP)] and blood sample measurements (after a 12 h fasting) were performed pre- and post-training. The investigation was carried out over a period of 16 weeks, with 12 weeks dedicated to the RT program and 4 weeks allocated for measurements. Anthropometric, muscular strength, body composition, and blood samples measurements were performed at weeks 1-2, and 15-16. A supervised progressive RT was performed between weeks 3-14. The CG did not perform any type of physical exercise during this period. However, given the possible positive effects of exercise, elderly women of this group were incorporated into a new exercise program after the end of this experiment. Data distribution was tested using the Shapiro Wilk test. Descriptive statistics are presented as means and standard deviations. Student's independent t-test and chi-square test were used to compare the control and intervention groups regarding the general characteristics and clinical conditions (categorical variables), respectively. Two-way analysis of covariance (ANCOVA) for repeated measures was applied for comparisons, with baseline scores used as covariates. When F-ratio was significant, Bonferroni's post hoc test was employed to identify the mean differences. Between group effect size (ES) was calculated to verify magnitude of the difference between groups. The Z-score of the percentage changes (from pre- to post-training) of the raw data for each parameter was calculated, and a total Z-score, derived from the all components was calculated. To verify the differences among groups on total Z-scores, a test T independent also was applied. For all statistical analyses, significance was accepted at P< 0.05. The data were analyzed using STATISTICA software version 13.2 (Statsoft Inc., Tulsa, OK, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental intervention | Experimental | Other: resistance trainingThe training group performed the resistance training (RT) program. All participants were personally supervised by physical education professionals with substantial RT experience. The sessions were performed 3 times per week on Mondays, Wednesdays, and Fridays, wirh 3 sets of 10-15 repetition maximums (RM).The RT program was performed in the following order: chest press, seated row, triceps pushdown, preacher curl, horizontal leg press, knee extension, leg curl, , and seated calf raise. Participants were afforded a 1 to 2 min rest interval between sets and 2 to 3 min between each exercise. The training load was consistent with the prescribed number of repetitions for the three sets of each exercise. |
| control group | No intervention | –The control group did not perform any type of physical exercise during the intervention period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years old or more;
- presented sarcopenic obesity SO [which was defined by the simultaneous presence of sarcopenia and obesity (Batsis et al., 2015; Studenski et al., 2014), whereas women were considered sarcopenic if appendicular lean soft tissue (LST) <15.02 kg, and obese if percentage of body fat ≥ 35% (Batsis et al., 2015)];
- physically independent;
- free from cardiac or orthopedic dysfunction;
- not receiving hormonal replacement and/or thyroid therapy;
Key exclusion criteria (3 listed)
- individuals with any metallic implant or artificial pacemaker, who had undergone surgery, who were unable to perform the tests and trainings;
- volunteers who failed the medical examination for any reason;
- refused or were unable to give consent.
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 |
|---|---|---|
| resistance trainingParticipants from TG performed program, executed in 3 sets of 10-15RM, 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was composed of 8 exercises comprising one exercise with free weights and seven with machines performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. All participants were personally supervised by physical education professionals with substantial RT experience to help ensure consistent and safe exercise performance. Participants were instructed to inhale during the eccentric phase and exhale during the concentric phase while maintaining a constant velocity of movement at a ratio of approximately 1:2 seconds (concentric and eccentric phases, respectively). Participants were afforded 1 to 2 min of rest between sets and 2 to 3 min between each exercise. The average duration of each session lasted approximately 50-60 minutes. | Other | experimental intervention |
Primary outcome
Change in body composition
Time frame: baseline and 12 weeks
To assess total and appendicular lean soft-tissue (LST), and total body fat (in kg), whole-body dual-energy X-ray absorptiometry DXA (Lunar Prodigy, model NRL 41990, GE Lunar, Madison, WI) was used.
Change in muscular strength
Time frame: baseline and 12 weeks
Functional capacity was evaluated using measures of muscular strength (total strength) by 1RM test assessed in the chest press (CP), knee extension (KE), and preacher curl (PC) exercises, performed in this exact order.The 1RM was recorded as the final load lifted in which the subject was able to complete only one single maximal execution. Total strength was determined by the sum of the 3 exercises and express in Kg.
Change in inflammatory biomarkers
Time frame: baseline and 12 weeks
Measurements of tumor necrosis factor alpha (TNF-α), and Interluekin-6 (IL-6), were determined by enzyme-linked immunosorbent assay (ELISA), according to the specifications of the manufacturer (Quantikine High Sensitivity Kit, R\&D Systems, Minneapolis, MN) and performed in a microplate reader Perkin Elmer, model EnSpire (Waltham, MA, USA). The results are presented in picograms per milliliter (pg/ml). All samples were determined in duplicate to guarantee the precision of the results.
Change in oxidative stress biomarkers
Time frame: baseline and 12 weeks
For the oxidative stress measurements, advanced oxidation protein products (AOPP) were determined in the plasma using a semiautomatic method described by Witko-Sarsat et al. (Witko-Sarsat et al., 1996). AOPP concentrations are expressed as micromoles per liter (μmol/L) of chloramines-T equivalents.
Change in functional capacity
Time frame: baseline and 12 weeks
Functional capacity was evaluated using measures of muscular strength (total strength), the 10-m walk test (10MW) and rising from sitting position test (RSP) express in (s). For the 10MW test older women were required to walk the distance of 10 m rapidly to evaluate the displacement speed; for the RSP, they were required to get up and sit down from a chair five times consecutively. In both tests the timer was triggered after the command "start now". At the moment the task was completed the timer was stopped.
Change in insulin-like growth factor 1 (IGF-1)
Time frame: baseline and 12 weeks
The concentrations of insulin-like growth factor 1 (IGF-1), were obtained in a specialized laboratory by a chemiluminescence method using a Liaison XL Immunoassay Analyzer (DiaSorin S.p.A, Saluggia, Italy). The values are expressed in (µU/mL)
2 secondary outcomes
Change in C-reative protein (CRP)
Time frame: baseline and 12 weeks
Changes in Anthropometry Parameters
Time frame: baseline and 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 14 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training in people with Sarcopenic Obesity and Inflammation, run by Universidade Estadual de Londrina.
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 7 inclusion and 3 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 14 Dec 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?
Change in body composition (time frame: baseline and 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2017.