The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
Primary Purpose
Covid19
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical activity counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Counseling group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
Physical activity level
Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.
General Quality of Life
Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire
Secondary Outcome Measures
Physical performance
Physical performance will be evaluated using Short Physical Performance Battery
Dyspnea during daily living activities
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.
Behaviour change level
Behaviour change level will be evaluated using Exercise Behaviour Change Scale.
General Pain
Pain will be evaluated using Visual Analog Scale
Fear of movement
Fear of movement will be evaluated using Tampa Scale of Kinesiophobia
Fatigue
Fatigue will be evaluated using Fatigue Severity Scale
Mental Health
Mental Health will be evaluated using Mental Health Continuum Short Form
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04853966
Brief Title
The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 17, 2021 (Actual)
Primary Completion Date
December 17, 2022 (Actual)
Study Completion Date
June 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Counseling group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical activity counseling
Intervention Description
Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.
Primary Outcome Measure Information:
Title
Physical activity level
Description
Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.
Time Frame
seven days
Title
General Quality of Life
Description
Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire
Time Frame
five minutes
Secondary Outcome Measure Information:
Title
Physical performance
Description
Physical performance will be evaluated using Short Physical Performance Battery
Time Frame
ten minutes
Title
Dyspnea during daily living activities
Description
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.
Time Frame
two minutes
Title
Behaviour change level
Description
Behaviour change level will be evaluated using Exercise Behaviour Change Scale.
Time Frame
five minutes
Title
General Pain
Description
Pain will be evaluated using Visual Analog Scale
Time Frame
one minute
Title
Fear of movement
Description
Fear of movement will be evaluated using Tampa Scale of Kinesiophobia
Time Frame
three minutes
Title
Fatigue
Description
Fatigue will be evaluated using Fatigue Severity Scale
Time Frame
Two minutes
Title
Mental Health
Description
Mental Health will be evaluated using Mental Health Continuum Short Form
Time Frame
three minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Emek
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
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