- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07490821
Effects of Physical Activity Training on Physical Fitness and Quality of Life in Paramedic Students
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Karaman
-
Karaman, Karaman, Turkey (Türkiye), 70400
- Karamanoglu Mehmetbey University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Katılım Kriterleri:
- Age 18-30 years
- Enrolled as a paramedic student in the participating institution
- Able and willing to participate in an 8-week physical activity program
- Provides written informed consent
- Able to attend scheduled assessment sessions (baseline, post-intervention, optional follow-up)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1: Physical Activity Training (Intervention Group)
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). |
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. |
|
No Intervention: Arm 2: Control Group
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Title: 30-Meter Sprint Time
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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
Time Frame: Baseline and 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Mass Index (BMI)
Time Frame: Baseline and 8 weeks
|
Description: Calculated as weight in kilograms divided by height in meters squared (kg/m2).Unit of Measure: kg/m2 (Weight and height will be combined to report BMI in kg/m².)
|
Baseline and 8 weeks
|
|
Change in Physical Activity Level
Time Frame: Baseline and 8 weeks
|
Description: Measured using the International Physical Activity Questionnaire (IPAQ). This questionnaire assesses the time spent being physically active in the last 7 days. Unit of Measure: MET-minutes per week Full Scale Name: International Physical Activity Questionnaire (IPAQ) Minimum Value: 0 (Theoretically) Maximum Value: No upper limit (varies according to the individual's reported activity duration). Interpretation: Higher scores indicate a better outcome. A higher MET-minute/week value suggests that the individual has a more active and physically healthier lifestyle. |
Baseline and 8 weeks
|
|
Change in Quality of Life Score
Time Frame: Baseline and 8 weeks
|
Description: Measured using the Short Form-36 (SF-36) Health Survey. Higher scores indicate better health-related quality of life. Unit of Measure: Score on a scale Full Scale Name: Short Form-36 Health Survey (SF-36) Minimum Value: 0 Maximum Value: 100 Interpretation: Higher scores indicate a better outcome. A score of 100 represents complete health and high quality of life, while a score of 0 represents significant health limitations and low quality of life. |
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-2025/59
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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
.
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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