The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions

September 17, 2023 updated by: Zeliha ÇELİK, Gazi University

The Effects of Physical Activity Tele-Counseling Intervention on Physical Activity, Functional Performance, and Quality of Life in Post-COVID-19 Conditions: A Randomized Controlled Trial

It has been found that physical activity recommendations with telerehabilitation in different disease groups improve the functional capacity, physical activities and mental health of the patients as much as the supervised exercise programs. However, there are no studies in the literature that provide online physical activity counseling in COVID-19 patients, and evaluate the effect of physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change levels. For this reason, this study aimed to evaluate the effect of online physical activity counseling on physical activity level, quality of life, physical performance, fatigue, kinesophobia, pain, dyspnea, mental health and behavior change level in COVID-19 patients.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

28

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

    • Emek
      • Ankara, Emek, Turkey, 06490
        • Gazi 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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals who have suffered COVID-19 and have passed at 3 months after the Polymerase Chain Reaction (PCR) test turned negative
  • Volunteering to participate in the research

Exclusion Criteria:

  • Having another diagnosed respiratory or cardiac problem
  • Having infections during the evaluation
  • Having a skeletal-muscular disease that may affect the evaluation results
  • Having neurological and psychiatric problems
  • Individuals with restrictions that prevent being physically active during the evaluation and counseling program.
  • Pregnant individuals

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Experimental: Counseling group
Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity level
Time Frame: seven days
Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.
seven days
General Quality of Life
Time Frame: five minutes
Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire
five minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance
Time Frame: ten minutes
Physical performance will be evaluated using Short Physical Performance Battery
ten minutes
Dyspnea during daily living activities
Time Frame: two minutes
Dyspnea using Modified Medical Research Council (MMRC) dyspnea scale will be evaluated. Modified Medical Research Council Dyspnea Scale, levels are graded as 0-4, higher scores imply higher dyspnea.
two minutes
Behaviour change level
Time Frame: five minutes
Behaviour change level will be evaluated using Exercise Behaviour Change Scale.
five minutes
General Pain
Time Frame: one minute
Pain will be evaluated using Visual Analog Scale
one minute
Fear of movement
Time Frame: three minutes
Fear of movement will be evaluated using Tampa Scale of Kinesiophobia
three minutes
Fatigue
Time Frame: Two minutes
Fatigue will be evaluated using Fatigue Severity Scale
Two minutes
Mental Health
Time Frame: three minutes
Mental Health will be evaluated using Mental Health Continuum Short Form
three minutes

Collaborators and Investigators

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

Sponsor

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)

April 17, 2021

Primary Completion (Actual)

December 17, 2022

Study Completion (Actual)

June 8, 2023

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

April 18, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

April 1, 2021

More Information

Terms related to this study

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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