NCT03370211

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2017

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

4 months

First QC Date

November 29, 2017

Last Update Submit

December 12, 2017

Conditions

Keywords

resistance traininginflammatory markersfunctional capacity

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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)

    baseline and 12 weeks

Secondary Outcomes (2)

  • Change in C-reative protein (CRP)

    baseline and 12 weeks

  • Changes in Anthropometry Parameters

    baseline and 12 weeks

Study Arms (2)

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.

Other: resistance training

control group

NO INTERVENTION

The control group did not perform any type of physical exercise during the intervention period.

Interventions

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.

experimental intervention

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammation

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 12, 2017

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

December 14, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share