- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04853966
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
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 219
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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