Resistance Training and Cardiometabolic Risk

November 27, 2023 updated by: Antony Karelis, Université du Québec a Montréal

Resistance Training and Cardiometabolic Risk in Women With Metabolically Healthy and Unhealthy Obesity

Little is known on the effects of resistance training (RT) alone in individuals with metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The present study aimed to examine the impact of RT on body composition, physical performance, lipid-lipoprotein profile, inflammation, and glucose-insulin homeostasis in 51 sedentary, postmenopausal women categorized as MHO vs MUHO, according to the Karelis and Rabasa- Lhoret classification or a single-phenotype adiposopathy approach (the plasma adiponectin (A)/leptin (L) ratio). Participants followed a 4-month weekly RT program of 3 non-consecutive days of 6 exercises of major muscle groups (3 sets of 10 repetitions at 80% 1-RM).

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

Several studies have examined MHO individuals' responses to weight loss interventions. Caloric restriction decreases body weight and body fat, notably visceral fat accumulation, of both MHO and MUHO pre- and postmenopausal women, although changes in MUHO women are usually more important. In addition, while insulin sensitivity of MUHO women increases after a 12-week diet, it is significantly worsened in postmenopausal MHO women. In this regard, previous works have shown discordant data of interventions including physical activity on the cardiometabolic risk and more particularly, insulin sensitivity. Indeed, diet or aerobic training alone or combined aerobic and resistance training (RT), in men and postmenopausal women yielded promising results as insulin sensitivity increased in both MUHO and MHO participants, with greater changes in the MUHO groups. However, the heterogeneity of the population (analysis without considering sex differences) as well as the type and duration (3 to 6 months) of different interventions make it difficult to generalize these results. As an example, insulin sensitivity was improved in MUHO men and women, while it remained unchanged in MHO participants after a 9-month intervention combining diet and exercise. Moreover, a 14-week community-based aerobic exercise program increased participants' cardiorespiratory fitness and reduced the number of metabolic syndrome components of MHO men and women. However, to the best of our knowledge, no study has compared yet the impact of a RT program on MUHO and MHO individuals.

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.
51

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • cessation of menstruation for more than 1 year and a follicle-stimulating hormone level ≥ 30 IU/L
  • sedentary for at least 3 months (< 2 h/week of structured exercise)
  • non-smokers
  • free of known inflammatory diseases
  • no use of hormone replacement therapy
  • body mass index ≥ 30 kg/m2
  • low to moderate alcohol consumption (< 2 drinks/day)

Exclusion criteria:

  • history of cardiovascular disease
  • type 2 diabetes
  • orthopedic limitations.

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: Non-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: Metabolically healthy obesity (MHO)
Healthy/normal metabolic profile
Other: Resistance exercise
After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.
Experimental: Metabolically unhealthy obesity (MUHO)
Abnormal metabolic profile
Other: Resistance exercise
After baseline testing, participants followed a progressive resistance training program 3 times a week for 4 months.

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
Insulin resistance (IR)
Time Frame: Baseline and after 4 months
Homeostasis Model Assessment (HOMA)-IR index = insulin (μUI/mL) x glucose (mmol/L)/22.5
Baseline and after 4 months

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.
Université du Québec a Montréal

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: Antony Karelis, PhD, Université du Québec a Montréal

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

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 1, 2009

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 9, 2011

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 9, 2011

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 12, 2023

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 19, 2023

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 26, 2023

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.
November 30, 2023

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.
November 27, 2023

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.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • UQAM-SAP

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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