NCT05100953

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 5, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

October 5, 2021

Last Update Submit

October 20, 2021

Conditions

Keywords

Physical ActivityQuality of LifeSleep HabitsDepressionVideoconferencingTelehealth

Outcome Measures

Primary Outcomes (10)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Behavioral: Physical Activity Counseling

Control Group

NO INTERVENTION

At the beginning of the study, a one-session briefing will be given on the benefits of physical activity.

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not having a co-morbid disease that would prevent physical activity
  • Having internet access and equipment to make video calls
  • Working remotely

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityDepression

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 5, 2021

First Posted

October 29, 2021

Study Start

October 5, 2021

Primary Completion

December 20, 2021

Study Completion

January 10, 2022

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

Locations