Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-01 @ 11:59 AM
Study NCT ID:
NCT04853966
Status:
COMPLETED
Last Update Posted:
2023-09-21
First Post:
2021-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-17', 'studyFirstSubmitDate': '2021-04-18', 'studyFirstSubmitQcDate': '2021-04-18', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity level', 'timeFrame': 'seven days', 'description': 'Physical activity level will be evaluated multi sensor activity monitor for 7 consecutive days.'}, {'measure': 'General Quality of Life', 'timeFrame': 'five minutes', 'description': 'Quality of Life will be evaluated using Short Form-36 (SF-36) Health Survey Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Physical performance', 'timeFrame': 'ten minutes', 'description': 'Physical performance will be evaluated using Short Physical Performance Battery'}, {'measure': 'Dyspnea during daily living activities', 'timeFrame': 'two minutes', '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.'}, {'measure': 'Behaviour change level', 'timeFrame': 'five minutes', 'description': 'Behaviour change level will be evaluated using Exercise Behaviour Change Scale.'}, {'measure': 'General Pain', 'timeFrame': 'one minute', 'description': 'Pain will be evaluated using Visual Analog Scale'}, {'measure': 'Fear of movement', 'timeFrame': 'three minutes', 'description': 'Fear of movement will be evaluated using Tampa Scale of Kinesiophobia'}, {'measure': 'Fatigue', 'timeFrame': 'Two minutes', 'description': 'Fatigue will be evaluated using Fatigue Severity Scale'}, {'measure': 'Mental Health', 'timeFrame': 'three minutes', 'description': 'Mental Health will be evaluated using Mental Health Continuum Short Form'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'referencesModule': {'references': [{'pmid': '38829396', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who have suffered COVID-19 and have passed at 3 months after the Polymerase Chain Reaction (PCR) test turned negative\n* Volunteering to participate in the research\n\nExclusion Criteria:\n\n* Having another diagnosed respiratory or cardiac problem\n* Having infections during the evaluation\n* Having a skeletal-muscular disease that may affect the evaluation results\n* Having neurological and psychiatric problems\n* Individuals with restrictions that prevent being physically active during the evaluation and counseling program.\n* Pregnant individuals'}, 'identificationModule': {'nctId': 'NCT04853966', 'briefTitle': 'The Effects of Physical Activity Tele-Counseling Intervention in Post-COVID-19 Conditions', 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '219'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Counseling group', 'interventionNames': ['Behavioral: Physical activity counseling']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Physical activity counseling', 'type': 'BEHAVIORAL', 'description': 'Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.', 'armGroupLabels': ['Counseling group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06490', 'city': 'Ankara', 'state': 'Emek', 'country': 'Turkey (Türkiye)', 'facility': 'Gazi University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zeliha ÇELİK', 'investigatorAffiliation': 'Gazi University'}}}}