Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-02 @ 4:41 AM
Study NCT ID:
NCT06568835
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Active Exercise on Maintenance Haemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Active exercise group: patients were asked to choose walking (no less than 8000 steps per day) or low-intensity aerobic exercise such as jogging, swimming, Tai Chi, etc., according to their own conditions, for no less than 30 minutes each time, at least 3 times per week, and the intensity of the exercise was determined by the need to increase the frequency and depth of breathing during the exercise, and it was appropriate to feel slightly tired but not exhausted (RPE score 12-16).\n\nExercise intensity should be at least 3 times a week, and the exercise intensity should be at a level that requires an increase in breathing rate and depth, allowing for dialogue and communication, slight sweating, and a feeling of being slightly tired but not exhausted (RPE score of 12 to 16).\n\nControl group: only receive conventional MHD treatment, no requirement for exercise.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-21', 'studyFirstSubmitDate': '2024-07-31', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mid-upper arm circumference of the non-internal fistula side（AC）', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'Measure the circumference of the non-internal fistula at the midpoint of the upper arm using a soft tape measure, in centimetres'}, {'measure': 'triceps skin-fold thickness of the non-internal fistula side（TSF）', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'Measurement of the skinfold at the midpoint of the upper arm on the non-internal fistula side by using a skinfold thickness gauge, in centimetres'}, {'measure': 'upper arm muscle circumference of the non-internal fistula side（AMC）', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'AMC（cm）= AC(cm) - 3.14 x TSF（cm）'}, {'measure': 'calf circumference', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'Measure the calf circumference using a soft tape measure, in centimetres'}, {'measure': 'grip strength', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'Using a grip strength meter, with the patient seated and gripping the handle firmly with the palm of the non-internal fistulae side, measure twice and record the maximum grip strength value'}, {'measure': 'Incidence of cardiovascular and cerebrovascular events', 'timeFrame': '1 year', 'description': 'Cardiovascular events include: heart failure episodes, sustained arrhythmias, myocardial infarction, and cerebrovascular events include: cerebral haemorrhage, cerebral infarction, transient ischaemic attack.'}], 'secondaryOutcomes': [{'measure': 'prealbumin', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'laboratory measurement indicators:prealbumin(g/L)'}, {'measure': 'albumin', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'laboratory measurement indicators:albumin(g/L)'}, {'measure': 'haemoglobin', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'laboratory measurement indicators:haemoglobin(g/L)'}, {'measure': 'blood lipids', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'laboratory measurement indicators:triglycerides, cholesterol, low-density lipoprotein, high-density lipoprotein'}, {'measure': 'c-reactive protein', 'timeFrame': 'Baseline and half year, 1 year', 'description': 'laboratory measurement indicators:c-reactive protein(mg/L)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Inflammation', 'Nutrition', 'Muscular Atrophy'], 'conditions': ['Renal Dialysis']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to discuss the effects of physical activity on nutrition, inflammation, muscle metabolism, and the occurrence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis. The main question it aims to answer is: can exercise improve nutritional and inflammatory status, enhance muscle strength, and reduce the incidence of cardiovascular and cerebrovascular events in patients with maintenance haemodialysis.\n\nResearchers will compared active exercise group to conventional treatment group to see the impact of exercise on maintenance haemodialysis patients.\n\nParticipants will:\n\nChoose low-intensity aerobic exercise workouts such as walking (no less than 8,000 steps per day) or jogging, swimming, Tai Chi, etc., according to their individual conditions, for no less than 30 minutes at a time, at least 3 times per week, and the intensity of the exercise should be based on an RPE score of 12 to 16.', 'detailedDescription': 'RPE: Rating of Perceived Exertion. RPE scores of 12 to 16 indicate the need for increased respiratory rate and depth during exercise, the ability to engage in conversational exchanges, light sweating, and a feeling of slight fatigue without reaching a state of exhaustion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MHD more than 3 months, 3 times per week, 3-4h each time;\n* Urea clearance index (Kt/V) \\>1.2;\n* Stable condition, no serious infection, tumour and cardiovascular disease;\n* Willing to join the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Combined with serious heart and lung disease: such as repeated heart failure, severe arrhythmia, unstable angina pectoris, severe pericardial effusion, severe heart valve disease, hypertrophic cardiomyopathy, aortic coarctation, severe emphysema, pulmonary heart disease, severe pulmonary hypertension (average pressure of the pulmonary artery \\> 55mmHg), etc.;\n* Combined with chronic joints, muscles, or vascular disease can not be or is not suitable for regular exercise, such as cerebrovascular disease; combined chronic joint, muscle or vascular disease can not or are not suitable for regular exercise, such as cerebrovascular disease sequelae, serious lower limb joint damage, severe myopathy, deep vein thrombosis, etc.;\n* unwilling to cooperate with the movement of people'}, 'identificationModule': {'nctId': 'NCT06568835', 'briefTitle': 'The Effect of Active Exercise on Maintenance Haemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Effect of Active Exercise on Nutritional and Inflammatory Status, Muscle Metabolism and Cardiovascular Events in Maintenance Haemodialysis Patients', 'orgStudyIdInfo': {'id': 'First ChongQing MU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': 'patients were asked to choose walking (no less than 8000 steps per day) or low-intensity aerobic exercise such as jogging, swimming, Tai Chi, etc., according to their own conditions, for no less than 30 minutes each time, at least 3 times per week, and the intensity of the exercise was determined by the need to increase the frequency and depth of breathing during the exercise, and it was appropriate to feel slightly tired but not exhausted (RPE score 12-16).\n\nExercise intensity should be at least 3 times a week, and the exercise intensity should be at a level that requires an increase in breathing rate and depth, allowing for dialogue and communication, slight sweating, and a feeling of being slightly tired but not exhausted (RPE score of 12 to 16).', 'interventionNames': ['Behavioral: exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'only receive conventional MHD treatment, no requirement for exercise.'}], 'interventions': [{'name': 'exercise', 'type': 'BEHAVIORAL', 'description': 'such as walking, jogging, swimming, Tai Chi, etc. It needs to be at a certain frequency and intensity', 'armGroupLabels': ['exercise group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yunfeng Xia, Dr.', 'role': 'CONTACT', 'email': 'xyf0920@126.com', 'phone': '86-23-89012256'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yunfeng Xia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Yunfeng Xia', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}