Effect of Resistance Exercise on Physical and Psychological Factors

November 27, 2024 updated by: Monira Aldhahi

Effects of Resistance Exercise-based Physical Activity Programme on Physical and Psychological Factors in Inactive Adults

Physical inactivity is a key risk factor for cardiovascular and metabolic disorders, negatively affecting emotional well-being by increasing psychological distress and reducing mental health. This study aimed to evaluate the impact of a resistance-based physical activity program on physical and psychological outcomes in physically inactive adults.

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

Background/Objectives: Sedentary behavior is a prevalent risk factor contributing to the development and progression of cardiovascular and metabolic diseases. Additionally, physical inactivity has been linked to diminished emotional well-being, characterized by elevated levels of psychological distress and compromised mental health. The present study was designed to investigate the effects of a resistance-focused physical activity intervention on both physical and psychological health outcomes in adults with chronically low levels of physical activity. A randomized controlled trial design was employed. The participant comprised 32 adults (mean age = 46.61 ± 7.33 years) included in the study. These individuals were randomly allocated to either a resistance exercise group (EG, n = 15) or a control group (CG, n = 17). Comprehensive assessments were conducted at baseline and following the 12-week intervention. These assessments included evaluations of muscle strength (knee flexors, knee extensors, ankle dorsiflexors, plantar flexors, and core isometric strength), static and dynamic balance, proprioception, and functional movement capacity (as measured by the Functional Movement Screen (FMS)). Participants' psychological states were quantified using the Depression, Anxiety, and Stress Scale-21 (DASS-21). The EG participated in a supervised resistance training program 3 days per week for 12 weeks, with each session lasting approximately 55-60 minutes. Conversely, the CG did not engage in any structured exercise program and were advised to maintain their customary lifestyle habits throughout the study duration.

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.
32

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Tekirdağ, Turkey
        • Department of Physiotherapy and Rehabilitation, Faculty of Medicine, Tekirdağ Namık Kemal University, Tekirdağ, Turkey,

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Aged between 40-60 years
  • Physically independent
  • Not having cardiac, orthopedic, or musculoskeletal dysfunctions
  • Not participating in regular physical activity more than once a week for the last 5 months before the beginning of the study

Exclusion Criteria:

  • Chronic ankle instability
  • Lower extremity musculoskeletal injury in the previous 6 months
  • Undergoing hormonal replacement therapy
  • Having uncontrolled diabetes
  • Having uncontrolled hypertension
  • Histroy of cardiovascular disease

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: Single

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 group
The 12-week resistance training program consisted of three supervised sessions per week, each lasting approximately 55-60 minutes. Sessions were structured as follows: 5-7 minute dynamic warm-up, 35-40 minutes of resistance training, and 4-5 minutes of stretching for active recovery. Participants were paired based on similar strength fitness levels and progressed according to the principle of periodized progressive overload.
Other: Resistance Training Program
The 12-week resistance training program consisted of three supervised sessions per week, each lasting approximately 55-60 minutes. Sessions were structured as follows: 5-7 minute dynamic warm-up, 35-40 minutes of resistance training, and 4-5 minutes of stretching for active recovery.Participants were paired based on similar strength fitness levels and progressed according to the principle of periodized progressive overload. Training was delivered using a circuit protocol with 2-3 sets per exercise. The initial 4-week phase included 2 sets per exercise, with 8-20 repetitions and 1-2 minutes rest between sets. .The program incorporated functional exercises targeting the lower extremities, core, and upper extremities, utilizing equipment such as resistance bands, medicine balls, jump ropes, dumbbells, bars, and stability balls. Participants performed exercises in a circuit sequence, with the intensity, number of sets, and repetitions
No Intervention: control group
did not participate in any structured exercise program during the 12-week study period. The participants were asked to maintain their usual lifestyle habits.

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 Movement Screen Test Protocol
Time Frame: From enrollment to the end of treatment at 12 weeks
a standardized assessment tool designed to evaluate fundamental movement patterns, identify asymmetries and weaknesses, and predict injury risk. The FMS consists of 7 movements: deep squat, hurdle step, in-line lunge, shoulder mobility, active straight leg raise, trunk stability push-up, and rotational stability.Each movement is scored on a 0-3 scale, with 3 indicating optimal performance. The maximum total score is 21.
From enrollment to the end of treatment at 12 weeks
Balance
Time Frame: From enrollment to the end of treatment at 12 weeks
Balance was assessed using the Sensbalance MiniBoard (Sensamove®, Utrecht, The Netherlands), a movable platform that provides an interactive challenge to balance control. Participants performed two tasks, each completed twice and held for 30 seconds
From enrollment to the end of treatment at 12 weeks
Strength tests
Time Frame: From enrollment to the end of treatment at 12 weeks
Lafayette Manual Muscle Test System (Model 01165) was used to determine isometric muscle strength. The Lafayette Manual Muscle Tester (MMT) system is an ergonomic handheld device used to objectively measure muscle strength.
From enrollment to the end of treatment at 12 weeks
Depression
Time Frame: From enrollment to the end of treatment at 12 weeks

The Depression, Anxiety, Stress Scale-21 (DASS-21) is a widely used self-report tool designed to measure depression, anxiety, and stress levels in participants. It consists of 21 items divided into three subscales:

  • Depression (e.g., feelings of sadness, lack of motivation)
  • Anxiety (e.g., nervousness, fearfulness)
  • Stress (e.g., tension, irritability)

Each item is scored on a 4-point Likert scale, with the following options:

  1. 0 = Did not apply to me at all
  2. 1 = Applied to me to some degree, or some of the time
  3. 2 = Applied to me to a considerable degree, or a good part of the time
  4. 3 = Applied to me very much, or most of the time

For each subscale, the scores range from 0 to 42 after adjustment.
From enrollment to the end of treatment at 12 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.
Monira Aldhahi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Namik Kemal University

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: Kübra Ustaömer, Namik Kemal University

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.
March 30, 2024

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.
November 20, 2024

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.
November 24, 2024

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).
November 25, 2024

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.
November 25, 2024

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.
November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 2, 2024

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, 2024

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, 2024

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.
  • 2023.135.06.21
  • Tekirdağ Namık Kemal Universit (Other Identifier: Tekirdağ Namık Kemal University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study investigators plan to disseminate the results of this trial through publication in peer-reviewed scientific journals and presentation at relevant conferences. While the investigators are committed to transparency and data sharing, individual participant data (IPD) may not be shared due to the potential risk of identifying participants despite anonymization efforts. Given the specific nature of the interventions and assessments, there is a possibility that participant identities could be inadvertently disclosed.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings