- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05100953
Application of Physical Activity Counseling Program
Application of Physical Activity Counseling Program in Healthy Adult Individuals
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey
- Medipol University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Not having a co-morbid disease that would prevent physical activity
- Having internet access and equipment to make video calls
- Working remotely
Exclusion Criteria:
- Having a diagnosis of any neurodegenerative or chronic disease
- Having significant cardiovascular, neuromuscular or endocrine disorders that limit regular physical activity
- Recent myocardial infarction or other acute cardiac event, unstable angina, uncontrolled cardiac arrhythmias
- In the past 2 months having had Covid 19
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group
After informing about the benefits of physical activity at the beginning of the study, physical activity counseling will be applied once a week for two months via videoconference.
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Physical activity counseling will be provided under supervision by the researcher physiotherapist via video conference and an individual physical activity program will be organized weekly for two months.
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NO_INTERVENTION: Control Group
At the beginning of the study, a one-session briefing will be given on the benefits of physical activity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Level
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
International Physical Activity Questionnaire of Short Form:IPAQ-SF records the last 7 day recall for four intensity levels of physical activity which is vigorous-intensity activity, moderate-intensity activity, walking, and sitting.
From IPAQ-SF, data were converted to Metabolic Equivalent minutes per week (MET-min/week) using.
Compendium average MET score (Walking = 3.3 METs, Moderate Physical Activity = 4.0 METs and Vigorous Physical Activity = 8.0 METs).
|
first measurement at the beginning of the study,change at first month, change at second month
|
Depression Level
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
Beck Depression Scale: BDI scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).
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first measurement at the beginning of the study,change at first month, change at second month
|
Sleep Quality
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
Pittsburgh Sleep Quality Index: In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty).
The component scores are summed to produce a global score (range 0 to 21).
Higher scores indicate worse sleep quality.
|
first measurement at the beginning of the study,change at first month, change at second month
|
Life Quality
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
World Health Organization Quality of Life Scale-Short Form: WHOQOL-BREF is a scale for the quality of life assessment developed by the World Health Organization. It is composed by 26 questions graded from 1 to 5. Scoring: 1 to 2.9 - needs improvement 3 to 3.9 - regular 4 to 4.9 - good 5 - very good Question 1 asks about the individual's overall perception of quality of life. Results refer to question 1. |
first measurement at the beginning of the study,change at first month, change at second month
|
Plank Test
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
The physical fitness of the participants was evaluated with the Plank Test.
The plank test is used to measure the strength and endurance of the core area.
The duration of stay in the plank position is recorded by the researcher.
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first measurement at the beginning of the study,change at first month, change at second month
|
Curl Up Test
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
The physical fitness of the participants was evaluated with the Curl Up Test.
The Curl-Up test is used to evaluate the strength and endurance of the abdominal muscles.The number of repetitions made in one minute is recorded.
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first measurement at the beginning of the study,change at first month, change at second month
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Modified Push Up Test
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
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The physical fitness of the participants was evaluated with the Modified Push Up Test.
The modified Push Up test evaluates chest muscles and upper extremity endurance.The number of modified push-ups performed correctly in succession without rest in 40 seconds is recorded.
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first measurement at the beginning of the study,change at first month, change at second month
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Squat Test
Time Frame: first measurement at the beginning of the study,change at first month, change at second month
|
The physical fitness of the participants was evaluated with the Squat Test.
The squat test evaluates lower extremity muscle endurance.The number of repetitions that the participant can do in one minute is recorded.
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first measurement at the beginning of the study,change at first month, change at second month
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Step Counts
Time Frame: first measurement at the beginning of the study, change at second month
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Participants recorded their step counts with a pedometer app they downloaded to their phones.
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first measurement at the beginning of the study, change at second month
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Body Mass Index
Time Frame: first measurement at the beginning of the study, change at second month
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BMI is calculated by dividing body weight (kg) by the square of the height in meters.
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first measurement at the beginning of the study, change at second month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Other Study ID Numbers
- NKOSE
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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