Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT03584633
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008209', 'term': 'Lymphedema'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chenw6@ccf.org', 'phone': '319-333-6166', 'title': 'Dr. Wei F. Chen', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.\n\nIndocyanine Green: The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time for Initial Disease Pattern to Appear', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.\n\nIndocyanine Green: The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ICG scan is performed every 5 minutes with the test subjects exercising until the initial disease pattern is seen. We expect initial disease pattern to appear within a minute following administration of ICG.', 'description': 'After subjects exercise, this outcome will be measured by indocyanine green lymphography scans, a non-radioactive scan that visualizes the lymphatic system', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Reach Indocyanine Green Lymphography Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.\n\nIndocyanine Green: The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'ICG scan was performed every 5 minutes until lymphographic plateau was reached. The Lymphographic plateau is defined as having no observable changes in lymphographic patterns. We estimate all patients to reach plateau within 20 minutes.', 'description': 'After subjects exercise, this outcome will be measured by indocyanine green lymphography, a non-radioactive scan that visualizes the lymphatic system.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.\n\nIndocyanine Green: The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.\n\nIndocyanine Green: The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '13.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diseased limbs', 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'limbs'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-12-24', 'size': 175449, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-03T11:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-03', 'studyFirstSubmitDate': '2018-06-05', 'resultsFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-03', 'studyFirstPostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for Initial Disease Pattern to Appear', 'timeFrame': 'ICG scan is performed every 5 minutes with the test subjects exercising until the initial disease pattern is seen. We expect initial disease pattern to appear within a minute following administration of ICG.', 'description': 'After subjects exercise, this outcome will be measured by indocyanine green lymphography scans, a non-radioactive scan that visualizes the lymphatic system'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Indocyanine Green Lymphography Steady State', 'timeFrame': 'ICG scan was performed every 5 minutes until lymphographic plateau was reached. The Lymphographic plateau is defined as having no observable changes in lymphographic patterns. We estimate all patients to reach plateau within 20 minutes.', 'description': 'After subjects exercise, this outcome will be measured by indocyanine green lymphography, a non-radioactive scan that visualizes the lymphatic system.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Indocyanine Green', 'Indocyanine Green Lymphography', 'Exercise'], 'conditions': ['Lymphedema']}, 'referencesModule': {'references': [{'pmid': '27333213', 'type': 'BACKGROUND', 'citation': 'Dylke ES, Schembri GP, Bailey DL, Bailey E, Ward LC, Refshauge K, Beith J, Black D, Kilbreath SL. Diagnosis of upper limb lymphedema: development of an evidence-based approach. Acta Oncol. 2016 Dec;55(12):1477-1483. doi: 10.1080/0284186X.2016.1191668. Epub 2016 Jun 22.'}, {'pmid': '21791706', 'type': 'BACKGROUND', 'citation': 'Lee BB, Laredo J. Contemporary role of lymphoscintigraphy: we can no longer afford to ignore! Phlebology. 2011 Aug;26(5):177-8. doi: 10.1258/phleb.2011.011e01. No abstract available.'}, {'pmid': '22675520', 'type': 'BACKGROUND', 'citation': 'Mihara M, Hara H, Araki J, Kikuchi K, Narushima M, Yamamoto T, Iida T, Yoshimatsu H, Murai N, Mitsui K, Okitsu T, Koshima I. Indocyanine green (ICG) lymphography is superior to lymphoscintigraphy for diagnostic imaging of early lymphedema of the upper limbs. PLoS One. 2012;7(6):e38182. doi: 10.1371/journal.pone.0038182. Epub 2012 Jun 4.'}, {'pmid': '27487485', 'type': 'BACKGROUND', 'citation': 'Chen WF, Zhao H, Yamamoto T, Hara H, Ding J. Indocyanine Green Lymphographic Evidence of Surgical Efficacy Following Microsurgical and Supermicrosurgical Lymphedema Reconstructions. J Reconstr Microsurg. 2016 Nov;32(9):688-698. doi: 10.1055/s-0036-1586254. Epub 2016 Aug 3.'}, {'pmid': '21921744', 'type': 'BACKGROUND', 'citation': 'Yamamoto T, Matsuda N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. The earliest finding of indocyanine green lymphography in asymptomatic limbs of lower extremity lymphedema patients secondary to cancer treatment: the modified dermal backflow stage and concept of subclinical lymphedema. Plast Reconstr Surg. 2011 Oct;128(4):314e-321e. doi: 10.1097/PRS.0b013e3182268da8.'}, {'pmid': '25488514', 'type': 'BACKGROUND', 'citation': 'Yamamoto T, Yoshimatsu H, Narushima M, Yamamoto N, Hayashi A, Koshima I. Indocyanine Green Lymphography Findings in Primary Leg Lymphedema. Eur J Vasc Endovasc Surg. 2015 Jan;49(1):95-102. doi: 10.1016/j.ejvs.2014.10.023.'}, {'pmid': '23930436', 'type': 'BACKGROUND', 'citation': 'International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013 Mar;46(1):1-11.'}, {'pmid': '16686578', 'type': 'BACKGROUND', 'citation': 'Johnson JH, Phipps LK. Preferred method of selecting exercise intensity in adult women. J Strength Cond Res. 2006 May;20(2):446-9. doi: 10.1519/R-17935.1.'}, {'pmid': '26440777', 'type': 'BACKGROUND', 'citation': 'Singh B, Disipio T, Peake J, Hayes SC. Systematic Review and Meta-Analysis of the Effects of Exercise for Those With Cancer-Related Lymphedema. Arch Phys Med Rehabil. 2016 Feb;97(2):302-315.e13. doi: 10.1016/j.apmr.2015.09.012. Epub 2015 Oct 9.'}, {'pmid': '26266100', 'type': 'BACKGROUND', 'citation': 'Morris C, Wonders KY. Concise review on the safety of exercise on symptoms of lymphedema. World J Clin Oncol. 2015 Aug 10;6(4):43-4. doi: 10.5306/wjco.v6.i4.43.'}, {'pmid': '20863266', 'type': 'BACKGROUND', 'citation': 'Desai P, Williams AG Jr, Prajapati P, Downey HF. Lymph flow in instrumented dogs varies with exercise intensity. Lymphat Res Biol. 2010 Sep;8(3):143-8. doi: 10.1089/lrb.2009.0029.'}, {'pmid': '18361766', 'type': 'BACKGROUND', 'citation': 'Downey HF, Durgam P, Williams AG Jr, Rajmane A, King HH, Stoll ST. Lymph flow in the thoracic duct of conscious dogs during lymphatic pump treatment, exercise, and expansion of extracellular fluid volume. Lymphat Res Biol. 2008;6(1):3-13. doi: 10.1089/lrb.2007.1017.'}, {'pmid': '21802319', 'type': 'BACKGROUND', 'citation': 'Cemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available.'}, {'pmid': '18534875', 'type': 'BACKGROUND', 'citation': 'Unno N, Nishiyama M, Suzuki M, Yamamoto N, Inuzuka K, Sagara D, Tanaka H, Konno H. Quantitative lymph imaging for assessment of lymph function using indocyanine green fluorescence lymphography. Eur J Vasc Endovasc Surg. 2008 Aug;36(2):230-236. doi: 10.1016/j.ejvs.2008.04.013. Epub 2008 Jun 4.'}, {'pmid': '21532424', 'type': 'BACKGROUND', 'citation': 'Yamamoto T, Narushima M, Doi K, Oshima A, Ogata F, Mihara M, Koshima I, Mundinger GS. Characteristic indocyanine green lymphography findings in lower extremity lymphedema: the generation of a novel lymphedema severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 May;127(5):1979-1986. doi: 10.1097/PRS.0b013e31820cf5df.'}, {'pmid': '21681123', 'type': 'BACKGROUND', 'citation': 'Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.'}, {'pmid': '18519968', 'type': 'BACKGROUND', 'citation': 'Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.'}, {'pmid': '22920313', 'type': 'BACKGROUND', 'citation': 'Lasinski BB, McKillip Thrift K, Squire D, Austin MK, Smith KM, Wanchai A, Green JM, Stewart BR, Cormier JN, Armer JM. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM R. 2012 Aug;4(8):580-601. doi: 10.1016/j.pmrj.2012.05.003.'}]}, 'descriptionModule': {'briefSummary': 'Indocyanine Green (ICG) lymphography is a relatively new imaging technique that allows for quick visualization of superficial lymph flow in real-time, without radiation exposure. This imaging is useful for diagnosing and assessing lymphedema. ICG lymphography has a higher sensitivity and specificity than lymphoscintigraphy, the current gold standard imaging device for lymphedema. ICG lymphography precisely and reliably diagnoses, tracks, and stages lymphedema severity, ranging from subclinical or early lymphedema to more advanced cases. The ICG contrast dye used to visualize the lymphatic system takes approximately six hours to plateau. Therefore, patients must wait six hours between their initial and delayed scans.\n\nThe purpose of this study is to determine if exercising on a Nu-step device between ICG initial and delayed scans would shorten the period of time a patient had to spend at the hospital on the day of their ICG lymphography.\n\nThe general procedures for this involve (after selecting subjects, consenting subjects, educating the subject on the protocol, along with other appropriate measures):\n\n* Taking baseline vitals (HR \\& SpO2) and limb circumference measurements\n* 5-minute period of time to acquaint subject with the exercise equipment (Nu-Step) at any level of exertion\n* injection of contrast agent to allow for visualization of the superficial lymphatic system by a qualified nurse\n* Initial scan\n* A 5-minute period of exercise at "moderate" level of exercise (This correlates to the rating of perceived exertion levels of 12-13; All exercise periods should be at this level and will be monitored by a provider)\n* Second scan \\& vitals\n* 5-minute period of exercise\n* Third scan \\& vitals\n\n o Continue 5-minute exercise period followed by scan \\& vitals until disease pattern emerges\n\n \\* Exercise for 5 minutes then scan and vitals until images reach steady state for two consecutive scans\n* Final vitals (HR \\& SpO2)\n\n \\* Repeat scan every 1 hour until the normal 6 hour scan to monitor for further changes in lymphatic pattern.\n* Exit survey', 'detailedDescription': "Following consent, the patients will answer the questions in the screening questionnaire and this data will be collected. Patients that do not screen out of the study (i.e. meet all inclusion criteria and none of the exclusion criteria) will continue with the study. Individuals who meet the exclusion criteria will not continue.\n\nStudy participants will be asked to go to the Rehabilitation Therapies clinic on the lower level of the main hospital for a one time visit. The visit will take approximately three to six hours.\n\nDuring the visit, height and weight will be measured. Circumference measurements of the arms and legs will also be measured with a measuring tape. Bioimpedance analysis of the limb will be performed to assess the fluid content in the limbs.\n\nPain Ease numbing spray will have been applied to three injection sites on the affected arm or leg. 0.1ml of 0.25% Indocyanine green (ICG) dye will then be injected into the distal arm or leg at three separate sites: two interdigital injections and one injection in the volar wrist or posterior to the medial malleolus.\n\nAn immediate scan will be acquired using an ICG lymphography device. The scan will take approximately five minutes to complete. The data from this image will be considered baseline. This image is part of the patient's normal care at our institution and would be done even if the subject was not in this study.\n\nThe participant will then use the Nu-Step exercise machine for five minutes at a rate of perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a pulse oximeter. After five minutes, a delayed scan will be performed with the NOVADAQ SPY Elite System and data will be recorded. The participant will continue to exercise for five minutes at an RPE of 12-13 and be scanned after every five minutes until the scans show no change in lymph pattern after two consecutive scans. The patient will be undergoing scanning and be exercising for a maximum of one hour.\n\nLimb circumference measurements and bioimpedance scans will be repeated after exercise has been completed. The scan will be repeated every 1 hour until the normal 6-hour scan to monitor for further changes in the lymphatic pattern.\n\nA post-intervention questionnaire will then be provided to the participant to complete discussing their exercise experience that day during the study, their previous ICG experiences, and their preference between this protocol and the current scanning process.\n\nDuring the study, the subject will be told when he/she is being photographed/recorded. The injections and scans are clinically-indicated and would occur whether the individual was in the study or not. The initial and last scans are clinically indicated to determine disease status. 3) clarify how the follow-up survey is completed via email"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients\n* Suspected lymphedema or previously diagnosed lymphedema\n* Between the ages of 18-85 years old.\n\nExclusion Criteria:\n\n* Allergies to iodine\n* pregnant\n* nursing\n* On daily heart medication\n* Have medical conditions affecting the heart, lungs or joint conditions that prevent prolonged physical activity of the arms or legs.'}, 'identificationModule': {'nctId': 'NCT03584633', 'briefTitle': 'Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment', 'orgStudyIdInfo': {'id': '201803867'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lymphedema', 'description': 'The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.', 'interventionNames': ['Drug: Indocyanine Green']}], 'interventions': [{'name': 'Indocyanine Green', 'type': 'DRUG', 'otherNames': ['NOVADAQ SPY Elite System Indocyanine Green Lymphography'], 'description': 'The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.', 'armGroupLabels': ['Lymphedema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Wei F Chen, MD, FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}