Application of Physical Activity Counseling Program

October 20, 2021 updated by: Nisa Nur KÖSE, Medipol University

Application of Physical Activity Counseling Program in Healthy Adult Individuals

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

48

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

      • Istanbul, Turkey
        • Medipol 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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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
  • 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.
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.
NO_INTERVENTION: Control Group
At the beginning of the study, a one-session briefing will be given on the benefits of physical activity.

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).
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.
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.
first measurement at the beginning of the study,change at first month, change at second month
Modified Push 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 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
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.
first measurement at the beginning of the study,change at first month, change at second month
Step Counts
Time Frame: first measurement at the beginning of the study, change at second month
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
Body Mass Index
Time Frame: first measurement at the beginning of the study, change at second month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

October 5, 2021

Primary Completion (ANTICIPATED)

December 20, 2021

Study Completion (ANTICIPATED)

January 10, 2022

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

October 29, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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