- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07429682
Physical Activity Awareness Education for Healthy Young Adults
Evaluating Physical Activity Awareness Training in Healthy Young Adults
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34400
- Istanbul Atlas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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).
Study Plan
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 |
|---|---|
|
Active Comparator: Education-Only (Awareness Program)
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.
|
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.
|
|
Experimental: Awareness Education + Weekly Supervised Exercise
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Static Forearm Plank Time (seconds)
Time Frame: Baseline (pre-intervention) and 10 weeks (post-intervention)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Trunk Flexion Endurance Time (seconds) at 10 Weeks
Time Frame: Baseline and 10 weeks (post-intervention)
|
Supine with hips and knees at 90° and trunk inclined to 60° on a prefabricated wedge.
After the wedge is moved back 10 cm, time is recorded until the participant visually re-contacts the wedge.
Standard method: feet stabilized with straps; modified method: clinician holds the feet.
Longer time indicates better endurance.
|
Baseline and 10 weeks (post-intervention)
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Change from Baseline in Modified Closed Kinetic Chain Upper Extremity Stability Test (Touches/15 s) at 10 Weeks
Time Frame: Baseline and 10 weeks (post-intervention)
|
Two parallel tape lines placed 91.4 cm apart.
From a push-up position with third fingers aligned over each line, the participant alternately touches the dorsum of the opposite hand for 15 s while maintaining trunk stability.
After one familiarization trial, three maximal trials are performed; the mean number of touches is analyzed.
Higher values indicate better functional stability.
|
Baseline and 10 weeks (post-intervention)
|
|
Change from Baseline in Bilateral Handgrip Strength (kg) at 10 Weeks
Time Frame: Baseline and 10 weeks (post-intervention)
|
Maximal isometric handgrip strength measured with a JAMAR dynamometer.
Participant seated, shoulder adducted, elbow at 90°, forearm and wrist neutral.
Three trials per hand with ≥30-s rest; the highest value per hand (kg) is recorded.
The outcome is the change from baseline to 10 weeks for both the dominant and non-dominant hands (reported separately).
Higher values indicate better strength.
|
Baseline and 10 weeks (post-intervention)
|
|
Change from Baseline in Standing Long Jump Distance (cm) at 10 Weeks
Time Frame: Baseline and 10 weeks (post-intervention)
|
From a two-footed standing start behind the line, the participant jumps forward maximally.
Distance from the take-off line to the nearest heel on landing is measured (cm).
At least two valid trials; the best distance is analyzed.
Higher values indicate better explosive lower-limb performance.
|
Baseline and 10 weeks (post-intervention)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATLAS-PA-AWARE-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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