Ignite Creation Date:
2025-12-26 @ 3:58 PM
Ignite Modification Date:
2025-12-29 @ 9:19 AM
Study NCT ID:
NCT04981106
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2021-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2021-07-14', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tampa kinesiophobia index', 'timeFrame': 'First measurement two weeks after surgery (intervetion 58.2; control 54.1)', 'description': 'Tampa is a 17-item scale'}, {'measure': 'WOMAC Osteoarthritis Index', 'timeFrame': 'First measurement two weeks after surgery (intervetion 89.3; control 88.1)', 'description': 'WOMAC is a valid and reliable index that is widely used for assessing the patients with osteoarthritis.'}, {'measure': "Beck's Depression Inventory", 'timeFrame': 'First measurement two weeks after surgery (intervetion 21.6; control 22.1)', 'description': '21 items in total.'}], 'secondaryOutcomes': [{'measure': 'Tampa kinesiophobia index', 'timeFrame': 'Second measurement six weeks after surgery (intervetion 36.9; control 42.9)', 'description': 'Tampa is a 17-item scale'}, {'measure': 'WOMAC Osteoarthritis Index', 'timeFrame': 'Second measurement six weeks after surgery (intervetion 29; control 70.5)', 'description': 'WOMAC is a valid and reliable index that is widely used for assessing the patients with'}, {'measure': "Beck's Depression Inventory", 'timeFrame': 'Second measurement six weeks after surgery (intervetion 6.9; control 13.2)', 'description': '21 items in total.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elastic band exercise', 'kinesiophobia', 'functional, psychological status'], 'conditions': ['Exercise']}, 'referencesModule': {'references': [{'pmid': '35776283', 'type': 'DERIVED', 'citation': 'Cetinkaya F, Karakoyun A. The effects of elastic band exercise on the pain, kinesiophobia, functional, and psychological status after total knee arthroplasty: a randomized controlled trial. Clin Rheumatol. 2022 Oct;41(10):3179-3188. doi: 10.1007/s10067-022-06266-0. Epub 2022 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'Aiming to determine the effects of elastic band exercise on kinesiophobia, functional capacity, and depression after the total knee arthroplasty, the present study was designed and carried out as a randomized controlled trial study. The study was carried out between October 2019 and April 2020 in the Physical Therapy and Rehabilitation Department of a training and research hospital.This study, the effects of elastic band exercise program on the pain, kinesiophobia, quality of life, depression, and functional capacity of TKA patients were examined. Elastic band exercise program significantly decreased the pain level, exercise fear, and depression level of patients and positively contributed to the quality of life and functional capacity.', 'detailedDescription': 'All the participants were subjected to walking training and a standard postoperative care and exercise protocol until discharged from the hospital. During discharging, all the participants in both groups were provided with explanation and illustration about how to perform the exercises. In order to prevent any problem, the participants in both groups were recommended to start the at-home rehabilitation programs, which incorporate knee movement exercises, to be ready 2 weeks (14 days) after the surgery and they were asked to continue their current exercise programs thus far. The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises.\n\nThe patients in intervention group were recommended to do, in addition to the at-home exercise program given to the patients in control group, elastic band exercises and researchers showed them how to use the elastic bands by making use of instructions.The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nUnilateral Total Knee Arthroplasty\n\nExclusion Criteria:\n\nBilateral Total Knee Arthroplasty'}, 'identificationModule': {'nctId': 'NCT04981106', 'briefTitle': 'Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status', 'organization': {'class': 'OTHER', 'fullName': 'Aksaray University'}, 'officialTitle': 'The Effects of Elastic Band Exercise on the Pain, Kinesiophobia, Functional, and Psychological Status After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2019/08-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Elastic Band Exercise', 'description': 'All the participants were subjected to walking training and a standard postoperative care and exercise protocol until discharged from the hospital. During discharging, all the participants in both groups were provided with explanation and illustration about how to perform the exercises. In order to prevent any problem, the participants in both groups were recommended to start the at-home rehabilitation programs, which incorporate knee movement exercises, to be ready 2 weeks (14 days) after the surgery and they were asked to continue their current exercise programs thus far.\n\nThe patients in intervention group were recommended to do, in addition to the at-home exercise program given to the patients in control group, elastic band exercises and researchers showed them how to use the elastic bands by making use of instructions.', 'interventionNames': ['Other: Elastic Band Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Exercise', 'description': 'The patients in control group were recommended to maintain only an at-home exercise program incorporating knee flexion and extension exercises.'}], 'interventions': [{'name': 'Elastic Band Exercise', 'type': 'OTHER', 'description': "The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.\n\nThrough phone calls, researchers asked the participants in intervention group if they do the elastic band exercises at home and if they had any difficulty while doing these exercises, as well as the reasons if they haven't done the exercises. When the participants in control and intervention groups returned to hospital after 4 weeks, the knee joint movement, lower extremity strength, knee joint pain, quality of life, kinesiophobia, and depression levels and physical functions of these groups were compared.", 'armGroupLabels': ['Elastic Band Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TR 68100', 'city': 'Aksaray', 'state': 'Select State', 'country': 'Turkey (Türkiye)', 'facility': 'Funda CETINKAYA', 'geoPoint': {'lat': 38.37255, 'lon': 34.02537}}], 'overallOfficials': [{'name': 'Funda CETINKAYA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aksaray University'}, {'name': 'Ahmet KARAKOYUN, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aksaray University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aksaray University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Funda Cetinkaya', 'investigatorAffiliation': 'Aksaray University'}}}}