Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-29 @ 2:20 AM
Study NCT ID:
NCT05257668
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2021-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradialytic High-Intensity Interval Training in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D000082262', 'term': 'Compulsive Exercise'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-17', 'studyFirstSubmitDate': '2021-11-30', 'studyFirstSubmitQcDate': '2022-02-24', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dialysis Adequacy', 'timeFrame': '8 weeks', 'description': 'Kt/V'}, {'measure': '6 Minute Walking Test', 'timeFrame': '8 weeks', 'description': 'Functional Capacity'}, {'measure': '5X Sit-to-Stand Test', 'timeFrame': '8 weeks', 'description': 'Functional Capacity'}, {'measure': 'Kidney Disease Quality of Life-36', 'timeFrame': '8 weeks', 'description': 'Life Quality'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Scale', 'timeFrame': '8 weeks', 'description': 'Mild depression (11-17 points) Moderate depression (18-29 points) Severe depression (30-63 points)'}, {'measure': 'Visual Analogue Scale', 'timeFrame': '8 weeks', 'description': 'To evaluate Fatigue. Each line is 100 mm in length - thus, scores fall between 0 and 100.Scoring : 0 : not all tired 100: extremely tired (left end of scale=not tired at all, right end of scale=extremely tired)'}, {'measure': 'Quadriceps muscle strength', 'timeFrame': '8 weeks', 'description': 'Muscle testing with dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intradialytic exercise', 'high-intensity interval training', 'chronic kidney disease', 'dialysis adequacy', 'functional capacity'], 'conditions': ['End Stage Renal Disease', 'Exercise, Compulsive']}, 'descriptionModule': {'briefSummary': "Chronic Kidney Disease (CKD) is defined as a chronic, progressive degeneration state in the regulation of the fluid-electrolyte balance of the kidney and metabolic-endocrine functions as a result of the glomerular filtration rate (GFR) falling below 60 ml/min/1.73 m², regardless of the etiology of the kidney disease. End Stage Renal Failure (ESRD) is the last stage of CRF and is a life-threatening condition. Although the majority of ESRD patients survive on dialysis, their quality of life and functional capacity decrease due to uremic cardiomyopathy, cardiovascular diseases, anemia, diabetes mellitus, bone diseases, deconditioning, fatigue, weakness, inactivity and accompanying psychological problems.\n\nRehabilitation program including exercise in CKD patients; The program, which is performed under observation on non-dialysis days, can be applied in three ways: the (intradialytic) rehabilitation program performed during hemodialysis in the dialysis unit, and the home exercise program. Intradialytic exercise (IDE) is defined as exercise training performed during the hemodialysis session to increase the patient's strength and endurance and thus target various physiological and psychosocial parameters. Three types of exercises are generally recommended in the exercise program for dialysis patients. These are aerobic exercise, strengthening exercise, and combined aerobic and resistance exercise program. Aerobic exercise (both on dialysis and on non-dialysis days) is the most common type of exercise used in hemodialysis patients. It is stated that physical exercise improves the exercise capacity, muscle strength, functional capacity and quality of life of patients receiving dialysis treatment, provides blood pressure control, reduces the risk of diabetes development and cardiovascular disease, alleviates depression and anxiety symptoms, increases survival and dialysis efficiency.\n\nWhen the literature is examined, no study has been found that examines how the application of high-intensity intermittent exercise training, which has very important advantages, in the intradialytic process has an effect. Therefore, the aim of our study is to compare the effects of intradialytic high-intensity intermittent exercise training and moderate-intensity exercise training on dialysis effectiveness, functional capacity and quality of life in hemodialysis patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 20-65\n* Having Stage 5 (ESRD) CRF according to GFR\n* Literate\n* Cooperative\n* Dialysis treatment for at least three months\n\nExclusion Criteria:\n\n* History of myocardial ischemia in the last 6 months\n* Uncontrollable diabetes mellitus,\n* Uncontrollable hypertension\n* Heart failure\n* Malignant disease\n* Mental retardation\n* Illiteracy\n* Uncooperative\n* Neurological or orthopedic disability'}, 'identificationModule': {'nctId': 'NCT05257668', 'briefTitle': 'Intradialytic High-Intensity Interval Training in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'The Effect of Intradialytic High-Intensity Interval Training and Moderate Intensity Training on Dialysis Adequacy and Functional Capacity in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'Intradialytic HIIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'High intensity interval training', 'interventionNames': ['Other: High Intensity Interval Exercise Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Moderate intensity training', 'interventionNames': ['Other: Moderate Intensity Exercise Training']}, {'type': 'NO_INTERVENTION', 'label': 'Group 3', 'description': 'Control'}], 'interventions': [{'name': 'High Intensity Interval Exercise Training', 'type': 'OTHER', 'description': 'High Intensity Interval Training Group', 'armGroupLabels': ['Group 1']}, {'name': 'Moderate Intensity Exercise Training', 'type': 'OTHER', 'description': 'Moderate Intensity Training Group', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34500', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University- Cerrahpasa', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yasemin ASLAN KELEŞ', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Physiotherapist', 'investigatorFullName': 'Yasemin ASLAN KELEŞ', 'investigatorAffiliation': 'Istanbul University - Cerrahpasa'}}}}