Clinical trial NCT04231058: Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Official title: The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dyspnea
Keywords: COPD
Transcutaneous Electrical Nerve Stimulation
Lead sponsor: Azienda USL Toscana Nord Ovest
Sponsor class: OTHER
Collaborators: name: Auxilium Vitae Volterra
First posted: 2020-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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:

1. 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;
2. Abdominal, upper- and lower-limb muscle activities involving lifting of progressively increasing light weight and shoulder and full-arm circling;
3. Education;
4. Nutritional programs and psychosocial counselling, when appropriate. A multidisciplinary team of chest physicians, nurses, physical therapists, a dietician, and a psychologist offered care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of moderate-to-severe COPD (ATS-ERS definition)
* Patients who have not participated in a respiratory rehabilitation program within the previous 3 months
* Patients admitted to the multi-specialist Rehabilitation Center Auxilium Vitae Volterra SPA for inpatient PR programme
* 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
* Expression of informed consent valid for participation in the study
* Good collaboration in the activities foreseen by the study

Exclusion Criteria:

* Insufficient degree of cooperation
* Inability to walk independently
* Denial of informed consent to participate in the study
* 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.

Primary outcomes:
measure: Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)
timeFrame: baseline
measure: Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI)
timeFrame: 2 week and 4 week
Secondary outcomes:
measure: Change in quality of life: SGRQ (St. George's Respiratory questionnaire)
timeFrame: baseline ,2 week and 4 week
measure: Change in functional capacity with the six-minute walk test (6mwt)
timeFrame: baseline , 2 and 4 week
measure: Change in respiratory volumes
timeFrame: baseline, 2 and 4 week
measure: Change in respiratory muscle function
timeFrame: baseline, 2 and 4 week
measure: Change in lung diffusion capacity
timeFrame: baseline, 2 and 4 week
measure: Impact of the disease
timeFrame: baseline, 2 and 4 week
measure: Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)
timeFrame: baseline, 2 and 4 week
Other outcomes:
Locations:
city: Volterra
country: Italy
facility: Santa Maria Maddalena Hospital
state: Pisa
Study officials:
affiliation: Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS
name: Guido Vagheggini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.