Covid19NCT04853966
The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
A study testing Physical activity counseling in people with Covid19, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Physical activity counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2021to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Covid19
- Being tested
- Physical activity counseling
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity counselingBehavioural
Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.
| Study group | Role | What they receive |
|---|---|---|
| Counseling group | Experimental | Not described Receives: Behavioral: Physical activity counseling |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.
Measured: seven days
General Quality of Life
Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire
Measured: five minutes
Secondary outcomes (7)
Physical performance
Physical performance will be evaluated using Short Physical Performance Battery
Measured: ten minutes
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.
Measured: two minutes
Behaviour change level
Behaviour change level will be evaluated using Exercise Behaviour Change Scale.
Measured: five minutes
General Pain
Pain will be evaluated using Visual Analog Scale
Measured: one minute
Fear of movement
Fear of movement will be evaluated using Tampa Scale of Kinesiophobia
Measured: three minutes
Fatigue
Fatigue will be evaluated using Fatigue Severity Scale
Measured: Two minutes
Mental Health
Mental Health will be evaluated using Mental Health Continuum Short Form
Measured: three minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start17 Apr 2021
- Primary completion17 Dec 2022
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeliha ÇELİK, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853966
- Sponsor's protocol ID
- 219
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Celik Z, Kafa N, Guzel NA, Kokturk N. 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. Expert Rev Respir Med. 2024 May;18(5):321-331. doi: 10.1080/17476348.2024.2363862. Epub 2024 Jun 11.
PubMed 38829396
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04853966
- Acronym / sponsor ID
- 219
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 17 Apr 2021 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling group | Experimental | Behavioral: Physical activity counseling |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity counselingPhysical activity counseling will be performed using physical activity behavior steps of the transtheoretical model. | Behavioural | Counseling group |
Primary outcome
Physical activity level
Time frame: seven days
Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.
General Quality of Life
Time frame: five minutes
Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire
7 secondary outcomes
Physical performance
Time frame: ten minutes
Dyspnea during daily living activities
Time frame: two minutes
Behaviour change level
Time frame: five minutes
General Pain
Time frame: one minute
Fear of movement
Time frame: three minutes
Fatigue
Time frame: Two minutes
Mental Health
Time frame: three minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 38829396Celik Z, Kafa N, Guzel NA, Kokturk N. 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. Expert Rev Respir Med. 2024 May;18(5):321-331. doi: 10.1080/17476348.2024.2363862. Epub 2024 Jun 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity counseling in people with Covid19, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: seven days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853966, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.