Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)

NCT04231058 | Suspended

• 1 other identifier: USL area vasta NordOvest
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dyspnea

Keywords

COPD; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Change in quality of life: SGRQ (St. George's Respiratory questionnaire)

  baseline ,2 week and 4 week

• Change in functional capacity with the six-minute walk test (6mwt)

  baseline , 2 and 4 week

• Change in respiratory volumes

  baseline, 2 and 4 week

• Change in respiratory muscle function

  baseline, 2 and 4 week

• Change in lung diffusion capacity

  baseline, 2 and 4 week

Study Arms (2)

Transcutaneous Electrical Nerve Stimulation (TENS)

EXPERIMENTAL

15 experimental subjects treated withTENS and Pulmonary Rehabilitation

Device: TENS and pulmonary rehabilitation

Rehabilitation

NO INTERVENTION

15 experimental subjects treated with Pulmonary Rehabilitation only

Interventions

TENS and pulmonary rehabilitation DEVICE

Three treatments with TENS per week for 3 weeks each , lasting 45 minutes

Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Toscana Nord Ovest: lead
• Auxilium Vitae Volterra: collaborator

Study Sites (1)

Santa Maria Maddalena Hospital

Volterra, Pisa, 56048, Italy

Location

Related Publications (9)

• 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: 25087837 BACKGROUND

• 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: 26028628 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.

  PMID: 21596958 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.

  PMID: 9032194 BACKGROUND

• 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: 28303156 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.

  PMID: 20601209 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.

  PMID: 18721121 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.

  PMID: 31517846 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.

  PMID: 22905352 RESULT

MeSH Terms

Conditions

Dyspnea; Pulmonary Disease, Chronic Obstructive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Guido Vagheggini, MD

  Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in Department of Anesthesia and Intensive Care Unit

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: January 18, 2020
• Study Start: May 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)