Clinical trial NCT03370211: Resistance Training and Sarcopenic Obesity Elderly Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenic Obesity
Inflammation
Functional Capacity
Keywords: resistance training
inflammatory markers
functional capacity
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2017-12-12
Enrollment: 37
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in body composition
timeFrame: baseline and 12 weeks
measure: Change in muscular strength
timeFrame: baseline and 12 weeks
measure: Change in inflammatory biomarkers
timeFrame: baseline and 12 weeks
measure: Change in oxidative stress biomarkers
timeFrame: baseline and 12 weeks
measure: Change in functional capacity
timeFrame: baseline and 12 weeks
measure: Change in insulin-like growth factor 1 (IGF-1)
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change in C-reative protein (CRP)
timeFrame: baseline and 12 weeks
measure: Changes in Anthropometry Parameters
timeFrame: baseline and 12 weeks
Other outcomes:
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