- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06708325
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
32
Phase
- 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
-
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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:
Each item is scored on a 4-point Likert scale, with the following options:
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
Collaborators
Investigators
- 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)
March 30, 2024
Primary Completion (Actual)
November 20, 2024
Study Completion (Actual)
November 24, 2024
Study Registration Dates
First Submitted
November 25, 2024
First Submitted That Met QC Criteria
November 25, 2024
First Posted (Actual)
November 27, 2024
Study Record Updates
Last Update Posted (Estimated)
December 2, 2024
Last Update Submitted That Met QC Criteria
November 27, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID 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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on Resistance Training Program
-
University Hospital, GhentCompleted
-
Cairo UniversityCompletedLow Back PainEgypt
-
Dalhousie UniversityCompletedHypertrophy | Body Weight Changes | Muscle SizeCanada
-
Catholic University of MurciaNot yet recruitingAmenorrhea | Relative Energy Deficiency in Sport | Low Energy Availability | Functional Hypothalamic Amenorrhea (FHA)Spain
-
Universite de La ReunionPhysio FormationRecruitingMenstrual Cycle | Resistance Training | Hormones | Women Health | Neuromuscular Function | Female Athlete | Muscle Strenght | Oral Contraceptive Pill | Periodized TrainingRéunion
-
Federal University of São PauloCompletedFibromyalgia
-
Charles University, Czech RepublicNot yet recruitingUltrasonic Diagnosis | Muscle ArchitectureCzechia
-
Federal University of Health Science of Porto AlegreUnknownLymphoma | Leukemia | Fatigue | Physical DisabilityBrazil
-
Northeast Normal UniversityCompleted
-
Yale UniversityYale-China AssociationRecruiting