NCT07490821

Brief Summary

Brief Title: Effects of an 8-week physical activity program in paramedic students (RCT) Official Title: EFFECTS OF PHYSICAL ACTIVITY TRAINING ON PHYSICAL FITNESS AND QUALITY OF LIFE IN PARAMEDIC STUDENTS This randomized controlled trial aims to examine the effects of regular physical activity training on physical fitness and quality of life in paramedic students. The study plans an eight-week physical activity program for paramedic students studying healthcare. The program will consist of exercises designed to improve physical endurance, muscle strength, flexibility, and overall physical performance. Main Hypothesis (H₁): Regular physical activity training will significantly improve the physical fitness level and quality of life of paramedic students. H₁a: Regular physical activity training increases the cardiovascular endurance of paramedic students. H₁b: Regular physical activity training significantly improves students' muscle strength and flexibility. H₁c: Students' body mass index (BMI) values are positively affected after regular physical activity training. H₁d: Students who participated in the physical activity program had significantly higher quality of life scores (SF-36 subscales) than the control group. This randomized controlled trial will test the effectiveness of an 8-week, 3-day-per-week physical activity program to assess physical fitness and quality of life in paramedic students. Participants will be randomly assigned to either the intervention (exercise program) or a standard-of-care/waiting control group. Primary outcomes include physical endurance (short form of the International Physical Activity Questionnaire (IPAQ)) and the SF-36 total score. Measurements will be taken at pre-intervention, after 8 weeks, and at 3-month follow-up. Study Type: Interventional. Allocation: Randomized. Intervention Model: Parallel Assignment. Masking: None Primary Outcome Measures: Change in physical endurance (distance, meters) with physical activity exercises - from baseline to week 8. Change in health-related quality of life by SF-36 total score - from baseline to week 8. Time Frame: Baseline, week 8, 3-month follow-up. The study suggests that regular physical activity-based training programs can improve both the professional resilience and quality of life of paramedic students. These findings are expected to contribute to the inclusion of physical activity-based modules in health education programs and positively impact the professional productivity of future paramedics.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

September 20, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

November 13, 2025

Last Update Submit

March 22, 2026

Conditions

Keywords

Physical FitnessQuality of LifePhysical ActivityParamedicsAllied Health PersonnelExercise, Body CompositionHealth Promotion

Outcome Measures

Primary Outcomes (4)

  • Title: 30-Meter Sprint Time

    Description: The time required to complete a 30-meter maximal sprint. The best (fastest) of two trials is recorded. Unit of Measure: Seconds

    Baseline and 8 weeks

  • Title: Upper Body Muscular Endurance

    Description: The total number of correct push-ups completed within a 30-second period. Unit of Measure: Number of repetitions

    Baseline and 8 weeks

  • Lower Body Explosive Power

    Description: The distance jumped forward from a standing position, measured from the starting line to the point of contact at landing. Unit of Measure: Centimeters

    Baseline and 8 weeks

  • Body Fat Percentage

    Description: The percentage of total body fat as measured by Bioelectrical Impedance Analysis (BIA) using the TANITA TBF-300 device. Unit of Measure: Percentage (%)

    Baseline and 8 weeks

Secondary Outcomes (3)

  • Change in Body Mass Index (BMI)

    Baseline and 8 weeks

  • Change in Physical Activity Level

    Baseline and 8 weeks

  • Change in Quality of Life Score

    Baseline and 8 weeks

Study Arms (2)

Arm 1: Physical Activity Training (Intervention Group)

EXPERIMENTAL

Arm 1: Physical Activity Training (Intervention Group) Intervention Type: Behavioral Intervention Description: Participants in the intervention group will complete an 8-week structured physical activity program. The program consists of three sessions per week, each lasting 60 minutes: 30 minutes cardiovascular exercise (walking, jogging, or interval training at moderate intensity) 20 minutes strength training (bodyweight exercises and resistance band exercises targeting major muscle groups) 10 minutes flexibility and cool-down exercises All sessions will be supervised by a trained exercise instructor. Participants will be encouraged to maintain adherence logs and report any adverse events. Pre- and post-intervention assessments will measure physical fitness parameters (Cooper test, 1-minute push-up and sit-up tests, flexibility) and health-related quality of life (SF-36).

Behavioral: Physical Activity Training

Arm 2: Control Group

NO INTERVENTION

Arm 2: Control Group (No Intervention) Intervention Type: No Intervention Intervention Description: Participants in the control group will continue their usual daily routine without participating in the structured physical activity program. They will be asked to avoid initiating any new exercise programs during the 8-week study period. Pre- and post-study assessments will be conducted using the same physical fitness and quality of life measures as the intervention group.

Interventions

Arm 1: Physical Activity Training (Intervention Group) Intervention Type: Behavioral Intervention Description: Participants in the intervention group will complete an 8-week structured physical activity program. The program consists of three sessions per week, each lasting 60 minutes: 30 minutes cardiovascular exercise (walking, jogging, or interval training at moderate intensity) 20 minutes strength training (bodyweight exercises and resistance band exercises targeting major muscle groups) 10 minutes flexibility and cool-down exercises All sessions will be supervised by a trained exercise instructor. Participants will be encouraged to maintain adherence logs and report any adverse events. Pre- and post-intervention assessments will measure physical fitness parameters Arm 2: Control Group Participants in the control group will continue their usual daily routine without participating in the structured physical activity program.

Arm 1: Physical Activity Training (Intervention Group)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • History of cardiovascular, respiratory, or musculoskeletal conditions contraindicating exercise
  • Pregnancy
  • Participation in another structured exercise program within the last 6 months
  • Any medical condition that would interfere with participation or pose risk during exercise, as determined by a physician
  • Inability to comply with the study schedule or procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karamanoğlu Mehmetbey University

Karaman, Karaman, 70400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking: Single (Outcomes Assessor) Masking Description: Participants and exercise instructors will be aware of group assignment due to the nature of the intervention. However, the individual responsible for collecting and analyzing outcome data (physical fitness tests and quality of life assessments) will be blinded to the group allocation in order to minimize assessment bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study uses a randomized, parallel-group design. Participants will be randomly assigned to either the intervention group, which will complete an 8-week structured physical activity training program, or a control group that maintains their usual daily routine. Pre- and post-intervention assessments will be conducted to evaluate changes in physical fitness parameters and health-related quality of life.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 13, 2025

First Posted

March 24, 2026

Study Start

September 20, 2025

Primary Completion

October 20, 2025

Study Completion

March 15, 2026

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Plan Description: De-identified individual participant data (IPD) from this study will be made available to other researchers upon reasonable request after publication of primary results. Data will be shared via a secure repository and will include physical fitness test scores, SF-36 questionnaire responses, and demographic information, with all personal identifiers removed. Requests can be submitted to the principal investigator at bsolmaz@kmu.edu.tr .

Locations