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lack of sufficient staff to conduct the study
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| Name | Class |
|---|---|
| Auxilium Vitae Volterra | OTHER |
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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).
In 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).
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.
Thirty 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.
An intensive inpatient PR programme will be applied to all participants. The programme will include the optimisation of drug therapy and daily sessions of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | 15 experimental subjects treated withTENS and Pulmonary Rehabilitation |
|
| Rehabilitation | No Intervention | 15 experimental subjects treated with Pulmonary Rehabilitation only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS and pulmonary rehabilitation | Device | Three treatments with TENS per week for 3 weeks each , lasting 45 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI) | 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 | baseline |
| Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI) | 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). | 2 week and 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life: SGRQ (St. George's Respiratory questionnaire) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guido Vagheggini, MD | Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Maria Maddalena Hospital | Volterra | Pisa | 56048 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25087837 | Background | 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. | |
| 26028628 | Background |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| baseline ,2 week and 4 week |
| Change in functional capacity with the six-minute walk test (6mwt) | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes . | baseline , 2 and 4 week |
| Change in respiratory volumes | 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) | baseline, 2 and 4 week |
| Change in respiratory muscle function | Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure) | baseline, 2 and 4 week |
| Change in lung diffusion capacity | Variation of Diffusing capacity (DLCO) | baseline, 2 and 4 week |
| Impact of the disease | Impact of the disease will be evaluated by the CAT (Chronic Obstructive Pulmonary Disease Assessment Test). CAT 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 | baseline, 2 and 4 week |
| Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES) | 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. The 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. Patients with scores over 30 will be diagnosed with having dissociative identity disorder | baseline, 2 and 4 week |
| 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. |
| 21596958 | Background | 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. |
| 9032194 | Background | 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. |
| 28303156 | Result | 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. |
| 20601209 | Result | 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. |
| 18721121 | Result | 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. |
| 31517846 | Result | 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. |
| 22905352 | Result | 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. |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |