HealthyNCT06708325
Effect of Resistance Exercise on Physical and Psychological Factors
A study testing Resistance Training Program in people with Healthy and Physically Inactive, run by Monira Aldhahi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Physically Inactive
- What is being tested?
- Resistance Training Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 24 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Physiotherapy and Rehabilitation, Faculty of Medicine, Tekirdağ Namık Kemal University, Tekirdağ, Turkey,
Tekirdağ
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy, Physically Inactive
- Being tested
- Resistance Training Program
- Keywords
- Strength, balance, depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training ProgramOther
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Resistance Training Program |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Depression
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:
- 0 = Did not apply to me at all
- 1 = Applied to me to some degree, or some of the time
- 2 = Applied to me to a considerable degree, or a good part of the time
- 3 = Applied to me very much, or most of the time
For each subscale, the scores range from 0 to 42 after adjustment.
Measured: From enrollment to the end of treatment at 12 weeks
Functional Movement Screen Test Protocol
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.
Measured: From enrollment to the end of treatment at 12 weeks
Balance
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
Measured: From enrollment to the end of treatment at 12 weeks
Strength tests
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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start30 Mar 2024
- Primary completion20 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monira Aldhahi
- Sponsor type
- University, hospital or other
- Collaborators
- Namik Kemal University
- Responsible party
- Sponsor-investigator, Monira Aldhahi, Princess Nourah Bint Abdulrahman University
- Investigators
- Kübra Ustaömer, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708325
- Sponsor's protocol ID
- 2023.135.06.21
- Other IDs
- Tekirdağ Namık Kemal Universit
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Resistance Exercise-based Physical Activity Programme on Physical and Psychological Factors in Inactive Adults
- ClinicalTrials.gov ID
- NCT06708325
- Acronym / sponsor ID
- 2023.135.06.21
- Conditions
- Healthy, Physically Inactive
- Keywords
- Strength, balance, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Monira AldhahiUniversity, hospital or other
- Collaborators
- Namik Kemal University
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Resistance Training ProgramThe 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. |
| control group | No intervention | –did not participate in any structured exercise program during the 12-week study period. The participants were asked to maintain their usual lifestyle habits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Chronic ankle instability
- Lower extremity musculoskeletal injury in the previous 6 months
- Undergoing hormonal replacement therapy
- Having uncontrolled diabetes
- Having uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Training ProgramThe 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 | Other | Exercise group |
Primary outcome
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.
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kübra Ustaömer principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training Program in people with Healthy and Physically Inactive, run by Monira Aldhahi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.