Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05173532
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012119', 'term': 'Respiration'}], 'ancestors': [{'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients will be blinded to their group assignment. At the time of their group assignment, they will be told that they are in either group "A" (which is actually the experimental group receiving balance training) or "B" (which is actually the active control group receiving the breathing and stretching exercise program), and that both groups may lead to better balance, neither are expected to worsen balance, and it is uncertain which one is more effective at improving balance. After their study participation, patients will guess which group they were in, then told if they guessed correctly.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks', 'timeFrame': '4 weeks', 'description': '8-item balance test battery, each item rated from 0-3 then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) \\< 30s (0) Unable, (#6) TIMED "GET UP \\& GO"'}, {'measure': 'Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks', 'timeFrame': '8 weeks', 'description': '8-item balance test battery, each item rated from 0-3, then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) \\< 30s (0) Unable, (#6) TIMED "GET UP \\& GO"'}], 'secondaryOutcomes': [{'measure': 'Global Rating of Change in Balance after 4 weeks', 'timeFrame': '4 weeks', 'description': '11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"'}, {'measure': 'Global Rating of Change in Balance after 8 weeks', 'timeFrame': '8 weeks', 'description': '11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Falls', 'Fall Risk', 'Aerobic Exercise', 'Strength Training', 'Fall Prevention', 'Stretching Exercise', 'Breathing Exercise', 'Randomized Controlled Trial', 'Clinical Prediction Rule', 'Minimal Clinically Important Difference'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '23975185', 'type': 'BACKGROUND', 'citation': 'Beauchamp MK, Janaudis-Ferreira T, Parreira V, Romano JM, Woon L, Goldstein RS, Brooks D. A randomized controlled trial of balance training during pulmonary rehabilitation for individuals with COPD. Chest. 2013 Dec;144(6):1803-1810. doi: 10.1378/chest.13-1093.'}, {'pmid': '20061508', 'type': 'BACKGROUND', 'citation': 'Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.'}, {'pmid': '17765523', 'type': 'BACKGROUND', 'citation': 'Buist AS, McBurnie MA, Vollmer WM, Gillespie S, Burney P, Mannino DM, Menezes AM, Sullivan SD, Lee TA, Weiss KB, Jensen RL, Marks GB, Gulsvik A, Nizankowska-Mogilnicka E; BOLD Collaborative Research Group. International variation in the prevalence of COPD (the BOLD Study): a population-based prevalence study. Lancet. 2007 Sep 1;370(9589):741-50. doi: 10.1016/S0140-6736(07)61377-4.'}, {'pmid': '28150362', 'type': 'BACKGROUND', 'citation': 'Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DM, Lopez Varela MV, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary. Respirology. 2017 Apr;22(3):575-601. doi: 10.1111/resp.13012. Epub 2017 Mar 7.'}, {'pmid': '27592402', 'type': 'BACKGROUND', 'citation': 'Moon Y, Sosnoff JJ. Safe Landing Strategies During a Fall: Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2017 Apr;98(4):783-794. doi: 10.1016/j.apmr.2016.08.460. Epub 2016 Aug 31.'}, {'pmid': '30512983', 'type': 'BACKGROUND', 'citation': 'Burton E, Farrier K, Lewin G, Petrich M, Boyle E, Hill KD. 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Epub 2006 Aug 24.'}, {'pmid': '25705944', 'type': 'BACKGROUND', 'citation': 'McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2015 Feb 23;2015(2):CD003793. doi: 10.1002/14651858.CD003793.pub3.'}, {'pmid': '26203790', 'type': 'BACKGROUND', 'citation': 'Beauchamp MK, Harrison SL, Goldstein RS, Brooks D. Interpretability of Change Scores in Measures of Balance in People With COPD. Chest. 2016 Mar;149(3):696-703. doi: 10.1378/chest.15-0717. Epub 2016 Jan 12.'}, {'pmid': '28352203', 'type': 'BACKGROUND', 'citation': 'Pedersen AB, Mikkelsen EM, Cronin-Fenton D, Kristensen NR, Pham TM, Pedersen L, Petersen I. Missing data and multiple imputation in clinical epidemiological research. Clin Epidemiol. 2017 Mar 15;9:157-166. doi: 10.2147/CLEP.S129785. eCollection 2017.'}, {'pmid': '25411322', 'type': 'BACKGROUND', 'citation': 'Austin PC, Steyerberg EW. Events per variable (EPV) and the relative performance of different strategies for estimating the out-of-sample validity of logistic regression models. Stat Methods Med Res. 2017 Apr;26(2):796-808. doi: 10.1177/0962280214558972. Epub 2014 Nov 19.'}, {'pmid': '10225667', 'type': 'RESULT', 'citation': 'Ito M, Kakizaki F, Tsuzura Y, Yamada M. Immediate effect of respiratory muscle stretch gymnastics and diaphragmatic breathing on respiratory pattern. Respiratory Muscle Conditioning Group. Intern Med. 1999 Feb;38(2):126-32. doi: 10.2169/internalmedicine.38.126.'}, {'pmid': '26906147', 'type': 'RESULT', 'citation': 'Garvey C, Bayles MP, Hamm LF, Hill K, Holland A, Limberg TM, Spruit MA. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: AN OFFICIAL STATEMENT FROM THE AMERICAN ASSOCIATION OF CARDIOVASCULAR AND PULMONARY REHABILITATION. J Cardiopulm Rehabil Prev. 2016 Mar-Apr;36(2):75-83. doi: 10.1097/HCR.0000000000000171.'}]}, 'descriptionModule': {'briefSummary': 'This study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.', 'detailedDescription': 'After receiving a detailed explanation of the study, including its risks and benefits, and providing informed consent, patients will be screened for eligibility criteria during a single 75-minute evaluation for participation in a physical therapy based pulmonary rehabilitation program. Those meeting eligibility criteria will be randomly assigned in blocks of four (by clinical site) in a single-blind manner (patients) in a 1:1 ratio to either balance training or a breathing and stretching exercise program. Both groups will receive respiratory muscle stretch exercises, aerobic exercise, strength training, and fall prevention education. The intervention phase will last 8 weeks, with patients being seen 3 times per week for 75 minute sessions supervised by a physical therapist or physical therapist assistant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version\n* age ≥ 60 years\n* both sexes\n* spirometrically-confirmed COPD of all disease severity stages\n* being independently ambulatory with or without a gait aid\n* medical clearance by a physician to participate in pulmonary rehabilitation\n* provision of informed consent.\n\nExclusion Criteria:\n\n* having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)\n* participation in a formal exercise program in the three months prior to the study baseline\n* an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.'}, 'identificationModule': {'nctId': 'NCT05173532', 'briefTitle': 'The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD', 'organization': {'class': 'OTHER', 'fullName': "Texas Woman's University"}, 'officialTitle': 'The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD', 'orgStudyIdInfo': {'id': 'IRB-FY2021-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Balance Training', 'description': 'Static and dynamic balance and gait stability training exercises are performed with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.', 'interventionNames': ['Other: Balance Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breathing and Stretching Exercises', 'description': 'Patients perform static stretches for all major muscle groups while performing diaphragmatic breathing with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.', 'interventionNames': ['Other: Breathing and Stretching Exercises']}], 'interventions': [{'name': 'Balance Training', 'type': 'OTHER', 'description': 'static and dynamic balance and gait stability exercises', 'armGroupLabels': ['Balance Training']}, {'name': 'Breathing and Stretching Exercises', 'type': 'OTHER', 'description': 'static stretching while performing diaphragmatic breathing', 'armGroupLabels': ['Breathing and Stretching Exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77077', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Breathing Center of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Breathing Center of Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'Breathing Center of Houston', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Breathing Center of Houston', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}], 'overallOfficials': [{'name': 'Christopher A Brown, PT, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Texas Woman's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Texas Woman's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christopher Brown', 'investigatorAffiliation': "Texas Woman's University"}}}}