- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03370211
Resistance Training and Sarcopenic Obesity Elderly Women
December 12, 2017 updated by: Crisieli Maria Tomeleri, Universidade Estadual de Londrina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
37
Phase
- 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
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental intervention
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.
|
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.
|
No Intervention: control group
The control group did not perform any type of physical exercise during the intervention period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and 12 weeks
|
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.
|
baseline and 12 weeks
|
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.
|
baseline and 12 weeks
|
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.
|
baseline and 12 weeks
|
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.
|
baseline and 12 weeks
|
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)
|
baseline and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in C-reative protein (CRP)
Time Frame: baseline and 12 weeks
|
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)
|
baseline and 12 weeks
|
Changes in Anthropometry Parameters
Time Frame: baseline and 12 weeks
|
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.
|
baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
March 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 29, 2017
First Submitted That Met QC Criteria
December 6, 2017
First Posted (Actual)
December 12, 2017
Study Record Updates
Last Update Posted (Actual)
December 14, 2017
Last Update Submitted That Met QC Criteria
December 12, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UELGEP2017
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
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.
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