Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-28 @ 7:10 PM
Study NCT ID:
NCT05485220
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2022-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neck pain', 'timeFrame': '8 weeks', 'description': "participants' neck pain perception with visual analog pain scale. 0= no pain, 10=maximum pain"}, {'measure': 'Spirometer measurements 1', 'timeFrame': '8 weeks', 'description': 'Forced Expiratory Volume during the first second (FEV1) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)'}, {'measure': 'Spirometer measurements 2', 'timeFrame': '8 weeks', 'description': 'Forced Vital Capacity (FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)'}, {'measure': 'Spirometer measurements 3', 'timeFrame': '8 weeks', 'description': '(FEV1/FVC) with spirometer (Spirolab III, Spirolab, Medical International Research) (FEV1 and FVC will be combined to report FEV1/FVC)'}, {'measure': 'Spirometer measurements 4', 'timeFrame': '8 weeks', 'description': 'Forced Expiratory Flow (FEF%25-75) with spirometer (Spirolab III, Spirolab, Medical International Research)'}, {'measure': 'MIP-MEP', 'timeFrame': '8 weeks', 'description': 'maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) with respiratory pressure meter (Micro Medical MicroMPM).'}, {'measure': 'chest circumference measurement', 'timeFrame': '8 weeks', 'description': 'chest circumference measurement with a tape measure.'}, {'measure': 'Cervical Joint Range of Motion', 'timeFrame': '8 weeks', 'description': 'Cervical Joint Range of Motion with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).'}, {'measure': 'Cervical Joint Position Error Test', 'timeFrame': '8 weeks', 'description': 'Cervical Joint Position Error Test with Cervical Range of Motion - 3 (Performance Attainment Associates, St. Paul, MN, 55117, United States) (CROM 3).'}, {'measure': 'Activation and endurance of deep cervical flexor muscles', 'timeFrame': '8 weeks', 'description': 'Activation and endurance of deep cervical flexor muscles with Stabilizer Pressure Biofeedback.'}, {'measure': 'craniovertebral angle', 'timeFrame': '8 weeks', 'description': 'Craniovertebral angle will be measured by taking 2 lateral photographs of the subject. Spinous process of C7 and the tragus of ear will be marked with a body marker. A horizontal line is drawn passing through C7 making a right angle with the vertical. Then, the angle between the line connecting C7 spinous process with the tragus of the ear and the horizontal line, will measured using a goniometer'}, {'measure': 'hand grip strength', 'timeFrame': '8 weeks', 'description': 'Hand grip strength with Jamar Hydraulic Hand Dynamometer.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'Neck pain is among the causes of morbidity that causes disability. Although it is not life-threatening, neck pain is one of the most important reasons for a decrease in the workforce. Since there is a close anatomical, musculoskeletal and neural connection between the cervical region and the thoracic spine, neck pain can affect respiratory functions by causing biomechanical changes in the thoracic spine and rib cage. The aim of this study is to investigate the effects of aerobic exercise and high-intensity interval training, which are known to have an effect on both the musculoskeletal system and respiratory functions, on the respiratory parameters and musculoskeletal system disorders and clinical outcomes of people with neck pain when applied with an arm ergometer.', 'detailedDescription': 'Patients will be divided into 3 groups as randomized controlled. Aerobic exercise will be applied to the first group and HIIT to the second group. The third group will be the control group.\n\nThe patients in the first group will be applied an aerobic exercise program with an arm ergometer. Peak workload will be determined by performing an exercise test with an arm ergometer and training will be given for 60-70% of the peak workload for 45 minutes with arm ergometer 3 days a week for 8 weeks.\n\nHIIT with arm ergometer will be applied to the patients in the second group. Peak workload will be determined by performing an exercise test with an arm ergometer, and HIIT will be performed with an arm ergometer for 45 minutes in total, 90-95% of peak workload for 30 seconds, 60 seconds in between, active recovery at 40-50% workload. After the patients receive training for 8 weeks, 3 times a week, post-treatment evaluations will be made.\n\nOnly evaluations will be made twice, with an interval of 8 weeks, for the patients in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients between the ages of 18-55,\n* Having neck pain for more than 3 months,\n* Having neck pain ≥3 cm in a 10 cm VAS and\n* Patients with non-specific neck pain who score \\> 10/50 on the Neck Disability Index will be included.\n\nExclusion Criteria:\n\n* Pregnant women,\n* Smokers,\n* BMI\\>40\n* Those with any cardiovascular or pulmonary disease,\n* Those who cannot exercise due to any medical condition,\n* Those who have received physical therapy for neck pain in the last 6 months,\n* Red flag (malignancy, spinal fracture, etc.),\n* Spinal fracture,\n* Shoulder fracture,\n* Shoulder subluxation,\n* Cervical or shoulder surgery,\n* Migraine,\n* Rheumatological diseases,\n* Those with cervical root compression syndrome,\n* Those with neurological/inflammatory spinal pathology,\n* Those with chronic whiplash and traumatic neck injury,\n* Persons with \\<24 points on the mini-mental test.'}, 'identificationModule': {'nctId': 'NCT05485220', 'briefTitle': 'The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training in Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'The Effects of Arm Ergometer Endurance Training and High-intensity Interval Training on Respiratory Parameters, Musculoskeletal System, and Clinical Symptoms in Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'KA-21111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aerobic exercise group', 'description': 'the participants do aerobic training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)', 'interventionNames': ['Other: Aerobic exercise']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity interval training group', 'description': 'the participants do High intensity interval training by an arm crank ergometer (Monark 881E Upper and Lower Body Ergometer)', 'interventionNames': ['Other: High-intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': "the participants don't do any exercises"}], 'interventions': [{'name': 'Aerobic exercise', 'type': 'OTHER', 'description': 'Aerobic exercise group: Peak workload will be determined by performing an exercise test on the patients. Training will be given at 60-70% of the peak workload for 45 minutes with an arm ergometer 3 days a week for 8 weeks.', 'armGroupLabels': ['aerobic exercise group']}, {'name': 'High-intensity interval training', 'type': 'OTHER', 'description': 'High-intensity interval training Group: Peak workload will be determined by performing an exercise test on the patients and arm ergometer HIIT will be done with a total of 45 minutes, 90-95% of the peak workload for 30 seconds, 60 seconds in between, active recovery at 40-50% workload, 3 days a week for 8 weeks.', 'armGroupLabels': ['High intensity interval training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'sinem ayyıldız çinar', 'role': 'CONTACT', 'email': 'ayyildizsnm@gmail.com', 'phone': '05068916464'}], 'facility': 'Sinem Ayyıldız Çinar', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'sinem ayyıldız çinar', 'role': 'CONTACT', 'email': 'sinem.ayyildiz@hacettepe.edu.tr', 'phone': '05068916464'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Sinem Ayyıldız Çinar', 'investigatorAffiliation': 'Hacettepe University'}}}}