NCT05133622

Brief Summary

Purpose: The aim of this study is to evaluate muscle strength, muscle endurance, flexibility, and balance in individuals after mild COVID-19 infection and compare them with healthy individuals. Methods: A total of 118 individuals, 59 individuals between the ages of 18-30 who had COVID-19 (not vaccinated) and 59 individuals who did not, will be included in the study. Lower and upper extremity muscle strength, flexibility, and static and dynamic balances of the individuals will be evaluated and compared with the control group. The descriptive characteristics of the individuals will be recorded. The physical activity level of the individuals will be determined by the Short Form of International Physical Activity Questionnaire. The strength of knee extension and elbow flexion will be evaluated with a dynamometer, and functional trunk strength will be evaluated with sit-ups and push-ups tests. Lateral bridge test, modified Biering-Sorensen test, trunk flexors endurance test, and prone bridge test will be used to evaluate muscle endurance. Participants will perform sit and reach test and back scratch test for flexibility. The one-leg stance test and the functional reach test will be used to evaluate static and dynamic balance. The level of fatigue experienced by individuals during walking and running will score according to the Modified Borg Scale. Results: The SPSS for Windows 19.0 (IBM SPSS Statistics for Windows, Armonk, NY: IBM Corp.) will be used for data analysis. The data will be expressed as mean standard deviation (x±SD) and percentage (n%). The homogeneity of the groups will be evaluated with the Levene Test. Between groups, muscle strength, flexibility, and balance values will be compared using the "Mann Whitney-U" Test. The statistical significance level will be accepted as a p \<0.05 value. Conclusion: The researchers will discuss the results in light of the recent literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

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

November 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 23, 2021

Last Update Submit

April 4, 2022

Conditions

Keywords

COVID-19FlexibilityPhysical FitnessMuscle strengthpostural balance

Outcome Measures

Primary Outcomes (12)

  • Quadriceps femoris strength

    To measure the knee extension strength, the individual brings the knee from 90 degrees flexion to full extension in sitting. To standardize the test, the lower extremities will be fixed of the chair with a belt, allowing full extension of the knee. Three measurements will be performed from the distal tibia with a dynamometer, and the score will be recorded in Newtons.

    Once time, 3 minutes

  • Biceps brachii strength

    Elbow flexion will also be measured in a sitting position in a chair. To standardize the given resistance, the upper extremity of the individual will be fixed to the arm support of the chair, allowing elbow flexion with a belt. During the measurement, the individual will try to flex the forearm in supination. Meanwhile, three measurements will be taken from the distal forearm with a dynamometer. The average score will be recorded in Newtons.

    Once time, 3 minutes

  • Upper extremity flexibility-Back scratch test

    The back-scratch test evaluates upper extremity flexibility. The individual will externally rotate one arm over her/his shoulder to reach the lowest point on the back with the palm facing the back. The other extremity reaches the highest point on the back with the palm facing forward by internal rotation of the other arm. The distance between the middle fingers of both hands will be measured with a tape measure. If the middle fingers do not touch each other, the distance between them is recorded as a minus value in centimeters, if fingers can reach completely, as a zero value, if the fingers cross each other, as a positive value in centimeters

    Once time, 3 minutes

  • Lower extremity flexibility-Sit and reach test

    Sit and reach test evaluates lower extremity flexibility. In the test, a sit and reach board with 30 cm height, 45 cm width, and 100 cm length is used. The "0" reference point is taken as the 25 cm inner part where the feet are placed on the sit and reach the board. The part closer to the individual from the reference point shows negative values, and the part towards the far side shows positive values. Individuals will reach as far as with their fingertips by placing their feet on a sit-and-reach board. The test is repeated three times. The average score is recorded

    Once time, 2 minutes

  • Functional strength of trunk muscles-Sit-ups test

    The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The physiotherapist will fix the feet and ask the individuals to do trunk flexion in the knee flexion position. The number of movements performed for 30 seconds will be recorded.

    Once time, 2 minutes

  • Functional strength of trunk muscles-Push-ups test

    The test will be in the prone position, with the hands at shoulder level and the elbows flexed, positioned near to the body. Individuals will raise the head, shoulders, and trunk from the ground with their elbows in full extension. The test is performed with the knees in full extension for men and modified knees in flexion for women. The number of movements performed for 30 seconds will be recorded.

    Once time, 2 minutes

  • Muscle Endurance-Lateral bridge test

    Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilizes the spine. Higher scores indicate a good level of endurance.

    Once time, 5 minutes

  • Muscle Endurance- Biering-Sorensen test

    The test measuring how many seconds the individual can keep the unsupported upper body (from the upper border of the iliac crest) horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. Higher scores indicate a good level of endurance.

    Once time, 5 minutes

  • Muscle Endurance-Trunk flexors endurance test

    Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue. The researcher stops the test when the individual cannot hold the assumed position. Higher scores indicate a good level of endurance.

    Once time, 5 minutes

  • Muscle Endurance- Prone bridge test

    The prone bridge test measures the muscular endurance of the abdominal muscles. Higher scores indicate a good level of endurance.

    Once time, 5 minutes

  • Static balance

    Single leg stance test Individuals bend one knee and place the sole on the other thigh and maintain their balance in this position. The test will be performed separately for the right and left extremities with eyes open and closed. The single-leg stance balance time was recorded as seconds.

    Once time, 5 minutes

  • Dynamic balance

    Functional reach test The functional reach test evaluates dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from standing while maintaining a fixed base of support. The scoring record is centimeter. Higher scores indicate a good level of balance

    Once time, 5 minutes

Secondary Outcomes (1)

  • Fatigue-modified Borg scale

    Once time, 2 minutes

Study Arms (2)

Covid-19 group

ACTIVE COMPARATOR

Individuals between the ages of 20-30 Individuals who were diagnosed with COVID-19 positive in the last 3-10 months and were treated with home isolation and whose last PCR test was negative Individuals who had not to get vaccinated Individuals whose physical activity level is between 600-3000 MET min/week according to "International Physical Activity Questionnaire-Short form (IPAQ-SF)" (sedentary)

Other: Physical Activity LevelOther: Evaluation of knee extension and elbow flexion muscle strengthOther: Evaluation of functional strength of trunk musclesOther: Muscle EnduranceOther: FlexibilityOther: BalanceOther: Fatigue

Control group

ACTIVE COMPARATOR

Individuals between the ages of 20-30 Individuals who have not been diagnosed with COVID-19 positive Individuals who had not to get vaccinated Individuals whose physical activity level is between 600-3000 MET min/week according to the IPAQ-SF (sedentary)

Other: Physical Activity LevelOther: Evaluation of knee extension and elbow flexion muscle strengthOther: Evaluation of functional strength of trunk musclesOther: Muscle EnduranceOther: FlexibilityOther: BalanceOther: Fatigue

Interventions

IPAQ-SF assesses the physical activity levels of the individuals. The short form of the questionnaire consists of seven questions and provides information about the time spent sitting, walking, moderately vigorous, and vigorous activities. In scoring, below 600 MET-min/week indicates individuals who are not physically active, 600-3000 MET-min/week values indicate low physical activity levels, and 3000 MET-min/week and above values indicate individuals with high physical activity levels. In our study, sedentary individuals who receive 600-3000 MET-min/week from the questionnaire will be included

Control groupCovid-19 group

To measure the knee extension strength, the individual brings the knee from 90 degrees flexion to full extension in sitting. To standardize the test, the lower extremities will be fixed of the chair with a belt, allowing full extension of the knee. Three measurements will be performed from the distal tibia with a dynamometer, and the score will be recorded in Newtons. Elbow flexion will also be measured in a sitting position in a chair. To standardize the given resistance, the upper extremity of the individual will be fixed to the arm support of the chair, allowing elbow flexion with a belt. During the measurement, the individual will try to flex the forearm in supination. Meanwhile, three measurements will be taken from the distal forearm with a dynamometer. The average score will be recorded in Newtons.

Control groupCovid-19 group

Sit-ups test: The sit-ups test is a measure the endurance of the abdominal and hip-flexor muscles. The physiotherapist will fix the feet and ask the individuals to do trunk flexion in the knee flexion position. The number of movements performed for 30 seconds will be recorded. Push-ups test: The test will be in the prone position, with the hands at shoulder level and the elbows flexed, positioned near to the body. Individuals will raise the head, shoulders, and trunk from the ground with their elbows in full extension. The test is performed with the knees in full extension for men and modified knees in flexion for women. The number of movements performed for 30 seconds will be recorded.

Control groupCovid-19 group

Lateral bridge test: Lateral bridge test involves static, isometric contractions of the lateral muscles on each side of the trunk that stabilizes the spine. Modified Biering-Sorensen test: The test measuring how many seconds the individual can keep the unsupported upper body horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest. Trunk flexors endurance test: Trunk flexion test involving a static, isometric contraction of the anterior muscles, stabilizing the spine until the individual exhibits fatigue. The researcher stops the test when the individual cannot hold the assumed position. Prone bridge test: The prone bridge test measures the muscular endurance of the abdominal muscles.

Control groupCovid-19 group

Back scratch test The back-scratch test evaluates upper extremity flexibility. The individual will externally rotate one arm over her/his shoulder to reach the lowest point on the back with the palm facing the back. The other extremity reaches the highest point on the back with the palm facing forward by internal rotation of the other arm. The distance between the middle fingers of both hands will be measured with a tape measure. Sit and reach test Sit and reach test evaluates lower extremity flexibility. In the test, a sit and reach board is used. The "0" reference point is taken as the 25 cm inner part where the feet are placed on the sit and reach the board. The part closer to the individual from the reference point shows negative values, and the part towards the far side shows positive values. Individuals will reach as far as with their fingertips by placing their feet on a sit-and-reach board.

Control groupCovid-19 group
BalanceOTHER

Single leg stance test Individuals bend one knee and place the sole on the other thigh and maintain their balance in this position. The test will be performed separately for the right and left extremities with eyes open and closed. The single-leg stance balance time was recorded as seconds (Linda,2013). Functional reach test The functional reach test evaluates dynamic balance and limit of stability. This test measures the distance between the length of an outstretched arm in a maximal forward reach from standing while maintaining a fixed base of support. The scoring record is centimeter. Higher scores indicate a good level of balance (Lin,2012).

Control groupCovid-19 group
FatigueOTHER

Individuals will score perceived fatigue during walking and running activities with the Modified Borg Scale. According to the scale, "0" indicates no fatigue, and a score of "10" indicates unbearable fatigue (Borg,1987).

Control groupCovid-19 group

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals between the ages of 20-30
  • Individuals who were diagnosed with COVID-19 positive in the last 3-10 months and were treated with home isolation and whose last PCR test was negative
  • Individuals who had not to get vaccinated
  • Individuals whose physical activity level is between 600-3000 MET min/week according to "International Physical Activity Questionnaire-Short form (IPAQ-SF)" (sedentary)
  • Individuals between the ages of 20-30
  • Individuals who have not been diagnosed with COVID-19 positive
  • Individuals who had not to get vaccinated
  • Individuals whose physical activity level is between 600-3000 MET min/week according to the IPAQ-SF (sedentary)

You may not qualify if:

  • Individuals who are hospitalized and treated for COVID-19
  • Individuals with previously diagnosed Chronic Obstructive Pulmonary Disease (COPD), heart disease, and/or rheumatic diseases
  • Individuals who have had surgery in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06790, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

Pliability

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Study Officials

  • Özlem Yürük, Assoc.Prof

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

November 23, 2021

First Posted

November 24, 2021

Study Start

December 1, 2021

Primary Completion

February 25, 2022

Study Completion

February 25, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations