Application of Physical Activity Counseling Program

Healthy Lifestyle Clinical Trial

Official title:

Application of Physical Activity Counseling Program in Healthy Adult Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05100953
• Other study ID #: NKOSE
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2021
• Est. completion date: January 10, 2022

Study information

• Verified date: October 2021
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abstract Implementation of Physical Activity Counseling Program in Healthy Adult Individuals It was planned to investigate the effects of physical activity counseling on physical fitness level, physical activity level, depression level, sleep quality, quality of life and the change in the number of daily steps. 48 healthy adults aged 18-65 years will be included in the study. Participants will be randomized to the experimental group receiving videoconferencing counseling for eight weeks and the control group receiving single-session informational counseling. Participants will be evaluated with online questionnaires and physical fitness tests during the video conference before the study begins, at the end of the first month and at the end of the second month. Online surveys to be applied; PACE Score, Physical Activity Readiness Questionnaire (PAR-Q), Short Form International Physical Activity Questionnaire (IPAQ-SF), Pittsburgh Sleep Quality Index (PUKI), Beck Depression Inventory (BDI), World Health Organization Quality of Life Scale-Short Form ( WHOQOL-BREF) and physical fitness tests; Plank Test, Curl Up Test, Modified Push Up Test and Squat Test. Demographic information of the participants such as age, weight, height will be recorded. In addition, all participants will record their step counts with the pedometer application they download to their phones one week before the study starts and for one week after the study ends.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: January 10, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Lifestyle

Intervention

Behavioral:
• Physical Activity Counseling
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.

Locations

Country	Name	City	State
Turkey	Medipol University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level	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
Primary	Depression Level	Beck Depression Scale: BDI scores of 0-13 indicate minimal depression, 14-19 (mild depression), 20-28 (moderate depression) and 29-63 (severe depression).	first measurement at the beginning of the study,change at first month, change at second month
Primary	Sleep Quality	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
Primary	Life Quality	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
Primary	Plank Test	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.	first measurement at the beginning of the study,change at first month, change at second month
Primary	Curl Up Test	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.	first measurement at the beginning of the study,change at first month, change at second month
Primary	Modified Push Up Test	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.	first measurement at the beginning of the study,change at first month, change at second month
Primary	Squat Test	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.	first measurement at the beginning of the study,change at first month, change at second month
Primary	Step Counts	Participants recorded their step counts with a pedometer app they downloaded to their phones.	first measurement at the beginning of the study, change at second month
Primary	Body Mass Index	BMI is calculated by dividing body weight (kg) by the square of the height in meters.	first measurement at the beginning of the study, change at second month