NCT07429682

Brief Summary

Background and Rationale: Physical inactivity in young adults is common and increases the risk of heart disease, diabetes, obesity, and some cancers. Awareness-based education that helps individuals reflect on daily routines may support lasting increases in physical activity better than information alone. Objective: To determine whether a 10-week Physical Activity Awareness education program-alone or combined with a brief weekly supervised exercise class-improves muscle performance and exercise participation in healthy, sedentary young adults. Study Design: Single-center, double-masked, randomized controlled trial. Participants are randomized to one of two parallel groups. Outcome assessors are blinded to group allocation; intervention staff are separate from assessors. Baseline and post-intervention assessments are performed over 10 weeks. Participants and Eligibility: Healthy volunteers aged 18-25 years who are inactive or minimally active (per standardized questionnaires), spend \>6 hours/day sitting (outside of sleep), and have body mass index ≤30 kg/m². Key exclusions include conditions that make exercise unsafe (e.g., significant visual/vestibular/neurologic disorders), recent spine or lower-limb surgery or fracture, severe musculoskeletal pain limiting movement, pregnancy risk, pacemaker or metal implants, or current athletic training. Interventions: Education Only: A 10-week Physical Activity Awareness education program delivered by physiotherapists (health benefits of activity, types of exercise, strategies to reduce sitting time, building enjoyable routines). Education + Exercise: The same education program plus one supervised group exercise class per week (40 minutes; music-based aerobic activity, core strengthening, warm-up and cool-down). Assessments and Endpoints: Primary Endpoint: Trunk endurance on the static forearm plank test (time in seconds maintaining proper alignment). Secondary Endpoints: Bilateral handgrip strength (best of three trials per hand, kilograms); Modified Closed Kinetic Chain Upper Extremity Stability Test (MCKCUEST) (number of alternating hand touches in 15 seconds while maintaining trunk stability); standing long jump (best distance, centimeters); and self-reported physical activity and exercise participation. Potential Benefits and Risks: Participants may gain practical knowledge and improvements in fitness and function. Risks are low for healthy adults but may include temporary muscle soreness, fatigue, or strain. Sessions are supervised by trained staff and exercises can be modified for comfort and safety. Confidentiality: Personal information is kept confidential. Data are coded and analyzed in aggregate; individual identities are not reported. Study Setting and Duration: University-based study with assessments at the start and end of a 10-week period. The study follows the Declaration of Helsinki and has institutional ethics approval.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2026

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

February 1, 2026

Enrollment Period

8 months

First QC Date

January 27, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Physical ActivitySedentary BehaviorHealth PromotionHealth EducationAwareness

Outcome Measures

Primary Outcomes (1)

  • Change in Static Forearm Plank Time (seconds)

    Trunk (core) endurance is assessed with the standard forearm plank test. Participants assume a prone forearm plank with elbows under shoulders and feet hip-width apart, maintaining neutral spine and pelvis. After one familiarization attempt, two timed trials are recorded with ≥2 minutes rest; the best valid time (seconds) is used. Assessors terminate timing upon loss of alignment or voluntary stop. The primary outcome is the change score (post - baseline); higher values indicate better endurance. Trained assessors, standardized instructions, and a written manual of procedures are used to ensure reliability.

    Baseline (pre-intervention) and 10 weeks (post-intervention)

Secondary Outcomes (4)

  • Change from Baseline in Trunk Flexion Endurance Time (seconds) at 10 Weeks

    Baseline and 10 weeks (post-intervention)

  • Change from Baseline in Modified Closed Kinetic Chain Upper Extremity Stability Test (Touches/15 s) at 10 Weeks

    Baseline and 10 weeks (post-intervention)

  • Change from Baseline in Bilateral Handgrip Strength (kg) at 10 Weeks

    Baseline and 10 weeks (post-intervention)

  • Change from Baseline in Standing Long Jump Distance (cm) at 10 Weeks

    Baseline and 10 weeks (post-intervention)

Study Arms (2)

Education-Only (Awareness Program)

ACTIVE COMPARATOR

Participants receive a 10-week, group-based Physical Activity Awareness education program delivered by physiotherapists. Weekly modules cover: health benefits of physical activity; differentiating physical activity vs exercise; strategies to reduce sitting time; behavior-change techniques (goal setting, self-monitoring, implementation intentions); sleep/screen-time hygiene; safety and progression. Brief reflection/home logs are used to support self-monitoring. No supervised exercise sessions are provided; participants continue usual daily activities.

Behavioral: Physical Activity Awareness Education

Awareness Education + Weekly Supervised Exercise

EXPERIMENTAL

Participants receive the same 10-week Awareness education as Arm 1 plus one supervised group exercise session per week (40 minutes). Each session includes a \~5-minute warm-up, \~20 minutes of rhythmic/aerobic activity, \~10 minutes of core/strength exercises, and a \~5-minute cool-down. Intensity targets moderate effort (e.g., RPE \~12-14) with modifications allowed for comfort and safety. Attendance is recorded to monitor adherence.

Behavioral: Weekly Supervised Group Exercise (40 min)

Interventions

Ten-week, group-based education delivered by physiotherapists to increase physical activity awareness and self-management. Weekly modules cover: health benefits of physical activity; differentiating physical activity vs exercise; strategies to reduce sitting time; behavior-change techniques (goal setting, self-monitoring, implementation intentions); sleep/screen-time hygiene; safety and progression; building enjoyable routines. Brief reflection/home logs support self-monitoring. No supervised exercise is provided within this intervention.

Education-Only (Awareness Program)

Add-on, once-weekly, 40-minute supervised group exercise session for 10 weeks. Session structure: \~5-min warm-up; \~20-min rhythmic/aerobic activity at moderate intensity (e.g., RPE 12-14); \~10-min core/strength work; \~5-min cool-down. Exercises are coach-guided with options to modify for comfort and safety. Attendance is recorded to monitor adherence.

Awareness Education + Weekly Supervised Exercise

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Classified as inactive or minimally active according to International Physical Activity Questionnaire (IPAQ) scores (Karaaslan et al., 2023).
  • Engaging in sedentary behavior, defined as an average of more than 6 hours per day of sitting or lying down (excluding sleep) and having an energy expenditure of \< 1.5 metabolic equivalents (METs) (Tremblay et al., 2017).
  • Provides informed consent.
  • Body mass index (BMI) of ≤ 30 kg/m² (Douris et al., 2012).

You may not qualify if:

  • Any visual, auditory, vestibular, or neurological impairment.
  • History of traumatic injury, fracture, or surgery involving the spine or lower extremities within the past year.
  • Severe musculoskeletal pain that limits joint movement.
  • Pregnancy risk.
  • Use of a pacemaker or presence of metallic implants.
  • Background of active athletic training.
  • Any health condition that contraindicates exercise participation (Akbas \& Unver, 2021).at contraindicated exercise participation (Akbaş \& Ünver, 2021).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Atlas University

Istanbul, Istanbul, 34400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivitySedentary BehaviorHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Individually randomized, two-arm, parallel-group superiority trial with an add-on design. All participants receive a 10-week Physical Activity Awareness education program; the experimental arm additionally receives one 40-minute supervised group exercise session per week. The unit of randomization and analysis is the individual participant (no clustering; no crossover). Allocation and masking: 1:1 allocation using a computer-generated sequence with allocation concealment (sequentially numbered, opaque, sealed envelopes opened after baseline testing). Outcome assessors (and data analysts) are blinded to group assignment; intervention providers do not perform assessments. Groups meet separately to minimize contamination. Timing and setting: Single-center university study with two assessment time points (baseline and post-intervention at 10 weeks).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

January 27, 2026

First Posted

February 24, 2026

Study Start

August 1, 2024

Primary Completion

April 1, 2025

Study Completion

January 1, 2026

Last Updated

February 24, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations