Effects of Elastic Resistance Training on Performance and Biochemical Parameters

September 26, 2017 updated by: University of Primorska

Effects of Elastic Resistance Training on Physical Performance, Inflammatory Marker and Myokines in Elderly Women

The aim of this study was to investigate the acute and chronic effect of elastic resistance exercise in elderly women living in a nursing home. The primary outcome was the functional performance and hand grip strength. The secondary outcomes were myokines and inflammatory markers analysis.

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

Evidence regarding the relationship between RT and systemic myokine responses, as well as inflammation and physical performance in elderly is limited. Thus, this study aimed to evaluate the effect of short-term progressive elastic resistance training on muscular strength and physical performance, as well as the acute and chronic response of myokines and inflammatory markers after resistance exercise in elderly women living in a nursing home. From January to February 2016, we invited 95 older women (≥ 65 years) living in nursing home in the south of Slovenia to participate in our study.

The experimental design consisted of 1) baseline testing; 2) acute elastic resistance exercises with post-exercise and 2h post-exercise biochemical analysis; 3) a 3 months of supervised, progressive elastic resistance training program of moderate intensity; and 4) post-training testing.

The quantification of biomarkers was done using the MAGPIX® system, magnetic bead-based multi-analyte panels and MILLIPLEX® Analyst 5.1 software (MAGPIX®, Merck Millipore) and a human premixed 4-plex kit (R&D System Inc., Minneapolis, MN, USA), strictly following the manufacturer's instructions.

Two-way mixed ANOVA model was used to test group × time interaction. Tukey's post hoc test was applied for statistically significant interaction. To test for significant differences between groups relating anthropometric and biochemical variables, we used a Student's t-test. All values are expressed as mean and standard deviation (SD). P values of <0.05 is considered statistically significant. Bonferroni's correction for multiple testing will be performed by multiplying the P value with the number of tests where appropriate. Statistical analyses will be carried out using the SPSS program, version 21 (Chicago, IL).

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.
20

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

65 years to 99 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • nursing home residents
  • participants did not perform any regular resistance training

Exclusion Criteria:

  • immobility
  • implantable cardiac peacemaker
  • severe dementia
  • terminal illness

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: 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.
Experimental: Exercise
Participant in this group performed an acute resistance exercise protocol. The exercise protocol consisted of general warm-up of 10 min, followed by 8 exercises with 2 sets of 8 repetition and 1 min between sets.
Other: Exercise
Exercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
Experimental: Training
Participants allocated to intervention group initiated the progressive resistance training program of moderate intensity, with three weekly sessions throughout the 12-week treatment period.
Other: Training
Each training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
Active Comparator: Control group
Participants allocated to control group did not receive any placebo or treatment.
Other: Control group
The control group did not receive any treatment.

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
Functional performance
Time Frame: 1 week
A short battery of physical performance tests (SPPB) was used to assess baseline and post-training lower extremity function (0-12 point scale).
1 week

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
Acute effect of resistance exercise
Time Frame: 4 hours
The acute effect of resistance exercise on plasma concentrations of myokines and inflammatory markers measured pre-, post- and 2h post-exercise.
4 hours
Biochemical analysis of chronic effect of resistance training
Time Frame: 2 weeks
The chronic effect of resistance training on plasma concentrations of myokines and inflammatory markers measured at baseline and post-training.
2 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.
University of Primorska

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: Felicita Urzi, MSc, University of Primorska Faculty of Mathematics, Natural Sciences and Information Technologies

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.
January 15, 2016

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.
June 30, 2016

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.
June 30, 2016

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).
September 6, 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.
September 11, 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.
September 13, 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.
September 28, 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.
September 26, 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.
September 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.
  • UP-FVZ-ERT-Myokine

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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