Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:02 PM
Study NCT ID:
NCT04231058
Status:
SUSPENDED
Last Update Posted:
2022-10-24
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004417', 'term': 'Dyspnea'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'whyStopped': 'lack of sufficient staff to conduct the study', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-20', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2020-01-15', 'lastUpdatePostDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)', 'timeFrame': 'baseline', 'description': 'Assessment of the perception of dyspnea with the basal dyspnea index (BDI) which measures the severity of dyspnea in a single state. The score ranges from 0 to 12. The lower the score, the worse the dyspnea severity'}, {'measure': 'Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI)', 'timeFrame': '2 week and 4 week', 'description': 'Evaluation of the perception of dyspnea with a transitional dyspnea index (TDI) that measures changes in the severity of dyspnea compared to the baseline established by the Baseline Dyspnea Index (BDI). Rated from seven degrees ranging from -3 (major deterioration) to +3 (major improvement).'}], 'secondaryOutcomes': [{'measure': "Change in quality of life: SGRQ (St. George's Respiratory questionnaire)", 'timeFrame': 'baseline ,2 week and 4 week', 'description': "Change in quality of life evaluated with the SGRQ (St. George's Respiratory questionnaire)that is an instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Composed of 50 items .Total score ranging - 9 to + 9. The lower the score, the more deterioration in severichange inty of dyspnea"}, {'measure': 'Change in functional capacity with the six-minute walk test (6mwt)', 'timeFrame': 'baseline , 2 and 4 week', 'description': 'The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes .'}, {'measure': 'Change in respiratory volumes', 'timeFrame': 'baseline, 2 and 4 week', 'description': 'Variation of Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), Vital capacity (VC) and Forced expiratory volume in the 1st second (FEV1)'}, {'measure': 'Change in respiratory muscle function', 'timeFrame': 'baseline, 2 and 4 week', 'description': 'Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)'}, {'measure': 'Change in lung diffusion capacity', 'timeFrame': 'baseline, 2 and 4 week', 'description': 'Variation of Diffusing capacity (DLCO)'}, {'measure': 'Impact of the disease', 'timeFrame': 'baseline, 2 and 4 week', 'description': 'Impact of the disease will be evaluated by the CAT (Chronic Obstructive Pulmonary Disease Assessment Test).\n\nCAT are simple questionnaires that may be used to determine the severity of symptoms. Scores on CAT range from 0-40 with the higher the score, the more severe the disease'}, {'measure': "Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)", 'timeFrame': 'baseline, 2 and 4 week', 'description': 'The Dissociative Experiences Scale (DES) is a psychological self-assessment questionnaire that measures dissociative symptoms. It contains twenty eight questions in which a percentage answer from 0 to 100% is given for each.\n\nThe overall result, in percentage from 0 to 100, is obtained by dividing the sum of the percentage of each individual question by 28 which is the total number of questions.\n\nPatients with scores over 30 will be diagnosed with having dissociative identity disorder'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COPD', 'Transcutaneous Electrical Nerve Stimulation'], 'conditions': ['Dyspnea']}, 'referencesModule': {'references': [{'pmid': '25087837', 'type': 'BACKGROUND', 'citation': 'Mazzoleni S, Montagnani G, Vagheggini G, Buono L, Moretti F, Dario P, Ambrosino N. Interactive videogame as rehabilitation tool of patients with chronic respiratory diseases: preliminary results of a feasibility study. Respir Med. 2014 Oct;108(10):1516-24. doi: 10.1016/j.rmed.2014.07.004. Epub 2014 Jul 16.'}, {'pmid': '26028628', 'type': 'BACKGROUND', 'citation': 'Celli BR, Decramer M, Wedzicha JA, Wilson KC, Agusti AA, Criner GJ, MacNee W, Make BJ, Rennard SI, Stockley RA, Vogelmeier C, Anzueto A, Au DH, Barnes PJ, Burgel PR, Calverley PM, Casanova C, Clini EM, Cooper CB, Coxson HO, Dusser DJ, Fabbri LM, Fahy B, Ferguson GT, Fisher A, Fletcher MJ, Hayot M, Hurst JR, Jones PW, Mahler DA, Maltais F, Mannino DM, Martinez FJ, Miravitlles M, Meek PM, Papi A, Rabe KF, Roche N, Sciurba FC, Sethi S, Siafakas N, Sin DD, Soriano JB, Stoller JK, Tashkin DP, Troosters T, Verleden GM, Verschakelen J, Vestbo J, Walsh JW, Washko GR, Wise RA, Wouters EF, ZuWallack RL; ATS/ERS Task Force for COPD Research. An official American Thoracic Society/European Respiratory Society statement: research questions in COPD. Eur Respir Rev. 2015 Jun;24(136):159-72. doi: 10.1183/16000617.00000315.'}, {'pmid': '21596958', 'type': 'BACKGROUND', 'citation': 'Montagnani G, Vagheggini G, Panait Vlad E, Berrighi D, Pantani L, Ambrosino N. Use of the Functional Independence Measure in people for whom weaning from mechanical ventilation is difficult. Phys Ther. 2011 Jul;91(7):1109-15. doi: 10.2522/ptj.20100369. Epub 2011 May 19.'}, {'pmid': '9032194', 'type': 'BACKGROUND', 'citation': 'Maltais F, LeBlanc P, Jobin J, Berube C, Bruneau J, Carrier L, Breton MJ, Falardeau G, Belleau R. Intensity of training and physiologic adaptation in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 1997 Feb;155(2):555-61. doi: 10.1164/ajrccm.155.2.9032194.'}, {'pmid': '28303156', 'type': 'RESULT', 'citation': 'Ngai SP, Spencer LM, Jones AY, Alison JA. Acu-TENS Reduces Breathlessness during Exercise in People with Chronic Obstructive Pulmonary Disease. Evid Based Complement Alternat Med. 2017;2017:3649257. doi: 10.1155/2017/3649257. Epub 2017 Feb 20.'}, {'pmid': '20601209', 'type': 'RESULT', 'citation': 'Ngai SP, Jones AY, Hui-Chan CW, Ko FW, Hui DS. Effect of 4 weeks of Acu-TENS on functional capacity and beta-endorphin level in subjects with chronic obstructive pulmonary disease: a randomized controlled trial. Respir Physiol Neurobiol. 2010 Aug 31;173(1):29-36. doi: 10.1016/j.resp.2010.06.005. Epub 2010 Jun 16.'}, {'pmid': '18721121', 'type': 'RESULT', 'citation': 'Lau KS, Jones AY. A single session of Acu-TENS increases FEV1 and reduces dyspnoea in patients with chronic obstructive pulmonary disease: a randomised, placebo-controlled trial. Aust J Physiother. 2008;54(3):179-84. doi: 10.1016/s0004-9514(08)70024-2.'}, {'pmid': '31517846', 'type': 'RESULT', 'citation': 'Yu M, Gao L, Kong Y, Yan Y, Shi Q, Si D, Bao H, Sun H, Li L, Li Y. Safety and efficacy of acupuncture for the treatment of chronic obstructive pulmonary disease: A systematic review protocol. Medicine (Baltimore). 2019 Sep;98(37):e17112. doi: 10.1097/MD.0000000000017112.'}, {'pmid': '22905352', 'type': 'RESULT', 'citation': 'Suzuki M, Muro S, Ando Y, Omori T, Shiota T, Endo K, Sato S, Aihara K, Matsumoto M, Suzuki S, Itotani R, Ishitoko M, Hara Y, Takemura M, Ueda T, Kagioka H, Hirabayashi M, Fukui M, Mishima M. A randomized, placebo-controlled trial of acupuncture in patients with chronic obstructive pulmonary disease (COPD): the COPD-acupuncture trial (CAT). Arch Intern Med. 2012 Jun 11;172(11):878-86. doi: 10.1001/archinternmed.2012.1233.'}]}, 'descriptionModule': {'briefSummary': 'Dyspnoea is one of the most important determinants of quality of life and often limits the activities of daily life, in subjects suffering from moderate-to-severe chronic obstructive pulmonary disease (COPD). Pharmachological treatment of dyspnoea is affected by several side effects and, in long-lasting treatments, a reduction of clinical efficacy may occur. Previous studies showed a reduction of perceived dyspnoea after trials of acupuncture or Transcutaneous Electrical Nerve Stimulation over acupoints (Acu-TENS).\n\nIn this study will be investigated the effect of Acu-TENS on lung function and dyspnoea in patients with moderate-to-severe COPD (Cronic Obstructive Pulmonary Disease).', 'detailedDescription': 'Aim of the study is to verify the effectiveness of treatment with Acu-TENS to reduce perceived dyspnoea in patients suffering from moderate-to severe COPD. Secondary aims are to investigate the effects of the above treatments on quality of life, exercise capacity, pulmonary lung function.\n\nThirty consecutive patients, admitted to Auxilium Vitae Rehabilitation Centre for intensive pulmonary rehabilitation (PR) programme, suffering from moderate-to-severe COPD, will be enrolled. Subjects will be randomly assigned to two groups with different treatments (n=15 group 1: experimental subjects - PR+Acu-TENS and n=15 group 2: control subjects - PR only) by sequential block randomization.\n\nAn intensive inpatient PR programme will be applied to all participants. The programme will include the optimisation of drug therapy and daily sessions of:\n\n1. Supervised incremental exercises on a treadmill, a cycle,and an arm ergometer according to the protocol suggested by Maltais et al. until the achievement of 30 min of continuous exercise at an intensity that elicited dyspnoea at level 5 on a modified Borg scale starting from a workload corresponding to 50% of maximal workload achieved during an initial incremental test;\n2. Abdominal, upper- and lower-limb muscle activities involving lifting of progressively increasing light weight and shoulder and full-arm circling;\n3. Education;\n4. Nutritional programs and psychosocial counselling, when appropriate. A multidisciplinary team of chest physicians, nurses, physical therapists, a dietician, and a psychologist offered care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of moderate-to-severe COPD (ATS-ERS definition)\n* Patients who have not participated in a respiratory rehabilitation program within the previous 3 months\n* Patients admitted to the multi-specialist Rehabilitation Center Auxilium Vitae Volterra SPA for inpatient PR programme\n* stable clinical conditions and absence of clinical deterioration, with stable dyspnea, cough and sputum; stability of blood gas values in the absence of signs of edema or heart failure\n* Expression of informed consent valid for participation in the study\n* Good collaboration in the activities foreseen by the study\n\nExclusion Criteria:\n\n* Insufficient degree of cooperation\n* Inability to walk independently\n* Denial of informed consent to participate in the study\n* patients with known serious cardiovascular diseases (unstable angina, advanced chronic heart failure, aortic aneurisms, etc.) contraindicating the inclusion in exercise training programmes; chronic neurological or musculoskeletal diseases impairing their ability to comply with study procedures; severe renal failure or end-stage dialysis, advanced cancer, epilepsy and other clinical conditions interfering with the procedures and the safety of the study.'}, 'identificationModule': {'nctId': 'NCT04231058', 'acronym': 'COPD', 'briefTitle': 'Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'OTHER', 'fullName': 'Azienda USL Toscana Nord Ovest'}, 'officialTitle': 'The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'USL area vasta NordOvest'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcutaneous Electrical Nerve Stimulation (TENS)', 'description': '15 experimental subjects treated withTENS and Pulmonary Rehabilitation', 'interventionNames': ['Device: TENS and pulmonary rehabilitation']}, {'type': 'NO_INTERVENTION', 'label': 'Rehabilitation', 'description': '15 experimental subjects treated with Pulmonary Rehabilitation only'}], 'interventions': [{'name': 'TENS and pulmonary rehabilitation', 'type': 'DEVICE', 'description': 'Three treatments with TENS per week for 3 weeks each , lasting 45 minutes', 'armGroupLabels': ['Transcutaneous Electrical Nerve Stimulation (TENS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56048', 'city': 'Volterra', 'state': 'Pisa', 'country': 'Italy', 'facility': 'Santa Maria Maddalena Hospital', 'geoPoint': {'lat': 43.40251, 'lon': 10.86152}}], 'overallOfficials': [{'name': 'Guido Vagheggini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Toscana Nord Ovest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Auxilium Vitae Volterra', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor in Department of Anesthesia and Intensive Care Unit', 'investigatorFullName': 'Alessandro Tani', 'investigatorAffiliation': 'Azienda USL Toscana Nord Ovest'}}}}