Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-02-08 @ 3:47 PM
Study NCT ID:
NCT02052050
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Core Stability Program in Colorectal Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089944', 'term': 'Core Stability'}], 'ancestors': [{'id': 'D004856', 'term': 'Postural Balance'}, {'id': 'D011434', 'term': 'Proprioception'}, {'id': 'D000084323', 'term': 'Vestibulocochlear Physiological Phenomena'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D012677', 'term': 'Sensation'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-01', 'studyFirstSubmitDate': '2014-01-28', 'studyFirstSubmitQcDate': '2014-01-30', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'Baseline- 8 weeks'}, {'measure': 'Pressure Pain Thresholds', 'timeFrame': 'Baseline- 8 weeks'}, {'measure': 'Muscle structure', 'timeFrame': 'Baseline- 8 weeks', 'description': 'An ultrasound device (MyLab™ 25, Esaote Medical Systems, Genova, Italy) and a 12 MHz linear probe will be used in this study. The depth of internal and external oblique and transversus abdominis, and depth and width of lumbar multifidus will be captured when the patient will be relaxed at the end of the expiration movement.'}], 'primaryOutcomes': [{'measure': 'Abdominal isometric endurance', 'timeFrame': 'Baseline- 8 weeks', 'description': 'Isometric endurance of trunk flexors will be used to determine endurance strength of abdominal muscles. Patients will be laid supine, maintaining hips and knees bent at 90 degrees, feet flat approximately 30 inches from the buttocks and arms extended with hands on knees without actually touching. Patients will be instructed to separate the trunk from the stretcher to the inferior angle of the scapula and maintain this position as long as possible. Time (in seconds) will be measured until a maximum of 90 seconds'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The Piper Fatigue Scale will be used for it measure. It scale includes 22 items and four dimensions (behavioural/severity, affective meaning, sensory and cognitive mood)'}, {'measure': 'Body composition:', 'timeFrame': 'Baseline- 8 weeks', 'description': 'It will be obtained with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)'}, {'measure': 'Pain:', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The participants will be completed a visual analogue scale to assess the presence of lower-back and/or abdominal pain. The Brief Pain Inventory (BPI) will be used to assess the interference and the experience of pain.'}, {'measure': 'Static balance', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The Flamingo Test'}, {'measure': 'Flexibility', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The "chair sit and reach test"'}, {'measure': 'Functional capacity', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The 6-min walk test with treadmill (H-P-COSMOS for graphics; Germany)'}, {'measure': 'Fitness perceived', 'timeFrame': 'Baseline- 8 weeks', 'description': 'The International Fitness Scale (IFIS)'}, {'measure': 'Lower back muscle strength', 'timeFrame': 'Baseline- 8 weeks', 'description': 'dynamometer (TKK 5002 Back-A; Takey, Tokyo, Japan)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colorectal-neoplasms,deep-muscles of the back,rehabilitation'], 'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '7599766', 'type': 'BACKGROUND', 'citation': 'Temple PC, Travis B, Sachs L, Strasser S, Choban P, Flancbaum L. Functioning and well-being of patients before and after elective surgical procedures. J Am Coll Surg. 1995 Jul;181(1):17-25.'}, {'pmid': '15049716', 'type': 'BACKGROUND', 'citation': 'Slattery ML. Physical activity and colorectal cancer. Sports Med. 2004;34(4):239-52. doi: 10.2165/00007256-200434040-00004.'}, {'pmid': '23017985', 'type': 'BACKGROUND', 'citation': 'Cantarero-Villanueva I, Fernandez-Lao C, Cuesta-Vargas AI, Del Moral-Avila R, Fernandez-de-Las-Penas C, Arroyo-Morales M. The effectiveness of a deep water aquatic exercise program in cancer-related fatigue in breast cancer survivors: a randomized controlled trial. Arch Phys Med Rehabil. 2013 Feb;94(2):221-30. doi: 10.1016/j.apmr.2012.09.008. Epub 2012 Sep 24.'}, {'pmid': '21792370', 'type': 'BACKGROUND', 'citation': 'Cantarero-Villanueva I, Fernandez-Lao C, Del Moral-Avila R, Fernandez-de-Las-Penas C, Feriche-Fernandez-Castanys MB, Arroyo-Morales M. Effectiveness of core stability exercises and recovery myofascial release massage on fatigue in breast cancer survivors: a randomized controlled clinical trial. Evid Based Complement Alternat Med. 2012;2012:620619. doi: 10.1155/2012/620619. Epub 2011 Jul 17.'}, {'pmid': '21705873', 'type': 'BACKGROUND', 'citation': 'Fernandez-Lao C, Cantarero-Villanueva I, Fernandez-de-Las-Penas C, del Moral-Avila R, Castro-Sanchez AM, Arroyo-Morales M. Effectiveness of a multidimensional physical therapy program on pain, pressure hypersensitivity, and trigger points in breast cancer survivors: a randomized controlled clinical trial. Clin J Pain. 2012 Feb;28(2):113-21. doi: 10.1097/AJP.0b013e318225dc02.'}, {'pmid': '27015381', 'type': 'DERIVED', 'citation': 'Cantarero-Villanueva I, Sanchez-Jimenez A, Galiano-Castillo N, Diaz-Rodriguez L, Martin-Martin L, Arroyo-Morales M. Effectiveness of Lumbopelvic Exercise in Colon Cancer Survivors: A Randomized Controlled Clinical Trial. Med Sci Sports Exerc. 2016 Aug;48(8):1438-46. doi: 10.1249/MSS.0000000000000917.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of physical training program to improve deep stabilizer muscle in colorectal cancer survivors', 'detailedDescription': 'Background: Colorectal cancer is the third most common cancer when considering both genders. Musculoskeletal alterations have been described related to techniques used during surgery, that it produces an inhibition of deep abdominal muscles. These muscles are in charge of lumbopelvic stabilization muscle linked to reduced ability to maintain independence in daily activity life that could have affected their quality of life\n\nObjective: The aim objective will be evaluated short and long-term effects of physical activity program for muscle stabilization.\n\nMethods: 20 colorectal cancer survivors will be recruited from the Department of Oncology of ClĂnico San Cecilio Hospital. Patients will be randomized in physical activity program group and usual care group. Physical activity groups will receive an eight week program form improve the muscle stabilization.\n\nDiscussion: Researchers attempts to increase the fitness level and reduce musculoskeletal disorders in colorectal cancer survivors through a physical activity interventions focusing in muscle stabilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients under partial colorectal resection to treat colon cancer\n* Diagnosis of I, II or IIIa stage of colorectal cancer\n* Completion of adjuvant therapy (except for hormone therapy)\n* Medical clearance of participation\n\nExclusion Criteria:\n\nParticipants will be excluded if they presents with cancer recurrence or if they will have undergone previous abdominal surgeries or will be diagnosed with concomitant conditions, such as previous lower-back pain or musculoskeletal conditions (e.g., osteoarthritis, fibromyalgia or chronic fatigue syndrome).'}, 'identificationModule': {'nctId': 'NCT02052050', 'briefTitle': 'Core Stability Program in Colorectal Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effectiveness of Core Stability Exercises on Abdominal Deep Muscles in Colorectal Cancer Survivors', 'orgStudyIdInfo': {'id': 'CEI2013-MP-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'core stability', 'description': 'Stabilized muscle program will consist of two months of individual physical training that it will be conducted 3 times/week for 90 min each. A correct progression to improve stabilization of deep abdominal muscles will be made.', 'interventionNames': ['Other: core stability']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'usual care'}], 'interventions': [{'name': 'core stability', 'type': 'OTHER', 'armGroupLabels': ['core stability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18071', 'city': 'Granada', 'state': 'Granada', 'country': 'Spain', 'facility': 'University of Granada. Faculty of Health Sciences', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Irene Cantarero Villanueva, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MD', 'investigatorFullName': 'Manuel Arroyo Morales', 'investigatorAffiliation': 'Universidad de Granada'}}}}