NCT06708325

Brief 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. This study aimed to evaluate the impact of a resistance-based physical activity program on physical and psychological outcomes in physically inactive adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 24, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

November 25, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Strengthbalancedepression

Outcome Measures

Primary Outcomes (4)

  • 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: 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

  • 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.

    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

    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.

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

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.

Interventions

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

Exercise group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Kübra Ustaömer

    Namik Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants and outcome assessors, the data analysts were masked to group assignment throughout the study. The data analysts were not present during the exercise sessions or assessments and did not have access to information that could potentially reveal whether data belonged to the exercise or control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 25, 2024

First Posted

November 27, 2024

Study Start

March 30, 2024

Primary Completion

November 20, 2024

Study Completion

November 24, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

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.

Locations