- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116474
Effect Of 8-Week Online Fitness Intervention Health Related Fitness
October 30, 2023 updated by: Gunay yildizer, Eskisehir Technical University
Effect Of 8-Week Online Fitness Intervention on Muscle Strength, Flexibility, Body Composition and Physical-Self Perception
The purpose of this study is to investigate the effectiveness of 8-week online delivered exercise program on actual and perceived physical fitness components.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Physical fitness is one of the leading concepts of health and well-being at all stages of life.
In certain context, individuals tend to engage in prolonged sedentary behaviors, and these contexts are considered sedentary-promoting environments.
These environments also detrimental on physical fitness and health.
University students and office workers who predominantly engage in sedentary behaviors, such as prolonged sitting and computer-based work, have consistently shown associations with various aspects of diminished physical fitness.
The online intervention protocols might be a good alternative for increasing fitness level for those who live or work in highly sedentary settings.
Hence, the purpose of this study is to investigate the effectiveness of 8-week online delivered exercise program on actual and perceived physical fitness components.
Specifically, body composition measured by DXA, upper body muscular strength, and flexibility are the main focus of this study.
Moreover, physical self-perception is also a focus of this study.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tepebaşı
-
Eskişehir, Tepebaşı, Turkey, 26555
- Eskişehir Technical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Working or studying at the university,
- Do not have any health problems that would prevent from participating in exercise,
- Not participating any another exercise/training program during the research process,
- Voluntarily participation
- Being suitable for exercise participation according to Physical Activity Readiness Questionnaire (PARQ) test results
Exclusion Criteria:
- Presence of any significant health conditions that may pose a risk during exercise (e.g., heart conditions, severe respiratory disorders, uncontrolled hypertension).
- A history of musculoskeletal injuries or conditions that would limit participation in physical fitness activities.
- Current or recent participation in another exercise or fitness program.
- Inability to provide informed consent or unwillingness to participate voluntarily.
- Any medical condition that contraindicates exercise or physical activity as determined by a healthcare professional.
- Pregnancy or postpartum period, depending on the specific requirements and goals of the intervention.
- Age restrictions (younger than 18).
- Cognitive impairments that would hinder the ability to understand and follow exercise instructions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web based intervention group
The web-based intervention group participated in an 8-week exercise program, which consisted of three sessions per week, each lasting approximately 20 to 35 minutes.
|
The exercise program has been designed according to the progressive overload method.
Therefore, the volume of the exercise program increased as the weeks progressed.
Exercise videos were uploaded to YouTube on Mondays, Wednesdays and Fridays send to participants via a message group to follow the program.
The videos featured the experts' explanations of the movements for each exercise..
The equipment that the participants should use in the training sessions was selected from the materials available at home (eg., use of water bottles instead of weight dumbbells).
The exercise sessions is divided into 3 parts: warm-up (2-4 min.
average), main part (14-19 min.
average), cool-down (3-5 min.
average).
The warm-up includes movements to increase the heart rate and warm up the muscles to be worked on for that session.
The main part of the exercise program also included rest breaks when the participants were asked to move and stretch.
|
|
No Intervention: Control Group
The control group did not engage in any prescribed exercise protocol.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Fat Mass
Time Frame: 8 weeks
|
Body fat mass is the weight of fat in the body, and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Fat Mass in Legs
Time Frame: 8 weeks
|
Fat mass in legs is the weight of fat in legs, and measured by Dual-Energy X-Ray.Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Fat Mass in Arms
Time Frame: 8 weeks
|
Fat mass in arms is the weight of fats in arms, and measured by Dual-Energy X-Ray Absorptiometry (DXA).The unit of measurement is expressed in grams
|
8 weeks
|
|
Fat Mass in Trunk
Time Frame: 8 weeks
|
Fat mass in trunk is the weight of fats in trunk and measured by Dual-Energy X-Ray Absorptiometry (DXA).The unit of measurement is expressed in grams
|
8 weeks
|
|
Fat Mass in Gynoid
Time Frame: 8 weeks
|
The Gynoid region is that around the hips and thighs.
Fat mass in gynoid is the weight of fats in gynoid region and measured by Dual-Energy X-Ray Absorptiometry (DXA).The unit of measurement is expressed in grams
|
8 weeks
|
|
Fat Mass in Android
Time Frame: 8 weeks
|
The Android region is that of the abdomen, Fat mass in android region is the weight of fats in this region and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Total Muscle Mass
Time Frame: 8 weeks
|
Total muscle mass is the weight of muscle in the body and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Muscle Mass in Legs
Time Frame: 8 weeks
|
Muscle mass in legs is the weight of muscle in the leg region and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Muscle Mass in Arms
Time Frame: 8 weeks
|
Muscle mass in arms is the weight of muscle in arms and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Muscle Mass inTrunk
Time Frame: 8 weeks
|
Muscle mass in trunk is the weight of muscle in trunk region and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Muscle Mass in Android
Time Frame: 8 weeks
|
The Android region is that of the abdomen; muscle mass in android is the weight of muscle in android region and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
|
Muscle Mass in Gynoid
Time Frame: 8 weeks
|
The Gynoid region is that around the hips and thighs; muscle mass in gynoid is the weight of muscle in gynoid region and measured by Dual-Energy X-Ray Absorptiometry (DXA).
The unit of measurement is expressed in grams
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Push-Up Test
Time Frame: 2 months
|
Participants were asked to place their hands flat on the ground under their shoulders, with a straight slanted line on shoulders, back and legs.
While performing the test, participants were expected to lowered the torso until the elbows are in line until 90 degrees angle with upper arms and shoulders were parallel to the ground, while the body were lifted up until the arms are straight at the lifting part.
Participants were asked to perform push-ups every 3 seconds and an auditory stimulus was utilized, they were instructed to do each repetition with their body moving rigidly in a roughly straight line.
|
2 months
|
|
Curl-Up Test
Time Frame: 8 weeks
|
The participants were told to lay supine on a mat with the knees bent at a 90 degrees angle, the legs spread apart, and the arms completely extended at the sides with the middle finger of both hands contacting a piece of tape.
The zero point was marked with the first piece of tape, and a second piece was placed 10 cm away.
A metronome was set to 20 repetitions per minute.
In time with the metronome, the participant was directed to curl up until his middle finger reached the second piece of tape.
|
8 weeks
|
|
Sit and Reach Test
Time Frame: 8 weeks
|
A sit and reach box (Lafayette Instrument Company, USA) with a scale marked on the upper side were placed against the wall.
The participants were seated barefoot, with their legs fully extended and hip-width apart from the testing box.
Participants were instructed to slowly reach forward and slide their fingers along the scale on top of the box by placing one hand over the other.
The goal was for participants to maintain the position for about 3 seconds with their knees as straight as they could The final position that the participant reaches were recorded to the nearest centimeter and set as the score for the test.
|
8 weeks
|
|
Perceived Body Fat
Time Frame: 8 weeks
|
Perceived body fat is one's own assessment of his or her own body fat.
The body fat subscale of Marsh's Physical Self-Description Questionnaire (PSDQ) was used to collect physical self-perception data.
The subscale consisted of six items, answered on a 7-point Likert scale.
The maximum score that can be obtained from this scale is 42, and the minimum score is 6.
The higher scores obtained in the subdimensions represent higher physical self-perception.
|
8 weeks
|
|
Perceived Physical Strength
Time Frame: 8 weeks
|
Perceived physical strength is one's own assessment of his or her own strength.
The strength subscale of Marsh's Physical Self-Description Questionnaire (PSDQ) was used to collect physical self-perception data.
The subscale consisted of six items, answered on a 7-point Likert scale.
The maximum score that can be obtained from this scale is 42, and the minimum score is 6.
The higher scores obtained in the subdimensions represent higher physical self-perception.
|
8 weeks
|
|
Perceived Flexibility
Time Frame: 8 weeks
|
Perceived flexibility is one's own assessment of his or her own flexibility.
The flexibility subscale of Marsh's Physical Self-Description Questionnaire (PSDQ) was used to collect physical self-perception data.
The subscale consisted of six items, answered on a 7-point Likert scale.
The maximum score that can be obtained from this scale is 42, and the minimum score is 6.
The higher scores obtained in the subdimensions represent higher physical self-perception.
|
8 weeks
|
|
Perceived Physical Health
Time Frame: 8 weeks
|
Perceived physical health is one's own assessment of his or her own health.
The physical health subscale of Marsh's Physical Self-Description Questionnaire (PSDQ) was used to collect physical self-perception data.
The subscale consisted of eight items, answered on a 7-point Likert scale.
The maximum score that can be obtained from this scale is 42, and the minimum score is 8.
The higher scores obtained in the subdimensions represent higher physical self-perception.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Günay Yıldızer, Ph.D., Eskişehir Tech. Uni.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2022
Primary Completion (Actual)
October 15, 2022
Study Completion (Actual)
October 30, 2022
Study Registration Dates
First Submitted
October 20, 2023
First Submitted That Met QC Criteria
October 30, 2023
First Posted (Actual)
November 3, 2023
Study Record Updates
Last Update Posted (Actual)
November 3, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EkisehirTU-SBF-GY-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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