Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-30 @ 9:40 AM
Study NCT ID:
NCT00248235
Status:
COMPLETED
Last Update Posted:
2024-11-05
First Post:
2005-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-04', 'studyFirstSubmitDate': '2005-11-01', 'studyFirstSubmitQcDate': '2005-11-01', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain and dysfunction (baseline, 12 weeks, 6 months, 12 months)', 'timeFrame': 'baseline, 12 weeks, 6 months, 12 months'}, {'measure': 'Active and passive range of motion (baseline, 12 weeks)', 'timeFrame': 'baseline, 12 weeks'}, {'measure': 'Muscular strength and endurance (baseline, 12 weeks)', 'timeFrame': 'baseline, 12 weeks'}, {'measure': 'Quality of life (baseline, 12 weeks, 6 months, 12 months)', 'timeFrame': 'baseline, 12 weeks, 6 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Anxiety, depression and fatigue (baseline, 12 weeks, 6 months, 12 months)', 'timeFrame': 'baseline, 12 weeks, 6 months, 12 months'}, {'measure': 'Nerve conduction testing (baseline, 12 weeks as indicated)', 'timeFrame': 'Baseline'}, {'measure': 'Electromyography (baseline, 12 weeks as indicated)', 'timeFrame': 'Baseline'}]}, 'conditionsModule': {'keywords': ['exercise', 'rehabilitation', 'head and neck neoplasms'], 'conditions': ['Head and Neck Neoplasms']}, 'referencesModule': {'references': [{'pmid': '15162353', 'type': 'BACKGROUND', 'citation': 'McNeely ML, Parliament M, Courneya KS, Seikaly H, Jha N, Scrimger R, Hanson J. A pilot study of a randomized controlled trial to evaluate the effects of progressive resistance exercise training on shoulder dysfunction caused by spinal accessory neurapraxia/neurectomy in head and neck cancer survivors. Head Neck. 2004 Jun;26(6):518-30. doi: 10.1002/hed.20010.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.', 'detailedDescription': 'We will be conducting a randomized controlled trial to evaluate the effects of progressive resistance exercise training (PRET) on shoulder and neck dysfunction due to spinal accessory neurapraxia/ neurectomy in patients with head and neck cancer. Sixty-four head and neck cancer survivors will be randomly assigned to PRET or standard care. Participants assigned to the PRET group will exercise 3 times per week for 12 weeks. The goal of the exercise program will be to enhance scapular stability, and improve mobility and strength of the upper extremity. The resistance exercise program will be progressive in terms of the number of sets and repetitions performed, as well as amount lifted, depending on baseline strength levels and overall performance status. The primary outcomes for the study include pain and dysfunction, active and passive range of motion measures, strength and endurance testing, and quality of life. Nerve conduction testing and electromyography will be performed to assess/ monitor the status of the spinal accessory nerve and trapezius muscle function respectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck\n2. Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection\n3. Karnofsky Performance Status greater than or equal to 60%\n4. No evidence of residual cancer in the neck and no distant (M0) metastasis\n5. Participants must have completed their head and neck cancer treatment\n\nExclusion Criteria:\n\n1. A history of shoulder or neck pathology unrelated to cancer treatment\n2. Serious co-morbid medical illness or psychiatric illness'}, 'identificationModule': {'nctId': 'NCT00248235', 'briefTitle': 'Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Randomized Controlled Trial of Progressive Resistance Exercise Training for Spinal Accessory Neurapraxia/ Neurectomy in Head and Neck Cancer Survivors', 'orgStudyIdInfo': {'id': 'HN-4-0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRET', 'description': 'Progressive Resistance Exercise Training: upper extremity 6-8 exercises', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': 'Standard Care: physical therapy - range of motion, 6-8 strengthening exercises', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'armGroupLabels': ['PRET', 'Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2H9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Behavioral Medicine Laboratory, University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Kerry S Courneya, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Faculty of Physical Education and Recreation, University of Alberta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}