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

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ClinicalTrials.gov Identifier: NCT04231058
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
Auxilium Vitae Volterra
Information provided by (Responsible Party):
Alessandro Tani, Azienda USL Toscana Nord Ovest

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).


Condition or disease Intervention/treatment Phase
Dyspnea Device: TENS and pulmonary rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transcutaneous Electrical Nerve Stimulation (TENS)
15 experimental subjects treated withTENS and Pulmonary Rehabilitation
Device: TENS and pulmonary rehabilitation
Three treatments with TENS per week for 3 weeks each , lasting 45 minutes

No Intervention: Rehabilitation
15 experimental subjects treated with Pulmonary Rehabilitation only



Primary Outcome Measures :
  1. Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI) [ Time Frame: baseline ]
    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

  2. Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI) [ Time Frame: 2 week and 4 week ]
    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).


Secondary Outcome Measures :
  1. Change in quality of life: SGRQ (St. George's Respiratory questionnaire) [ Time Frame: baseline ,2 week and 4 week ]
    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

  2. Change in functional capacity with the six-minute walk test (6mwt) [ Time Frame: baseline , 2 and 4 week ]
    The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes .

  3. Change in respiratory volumes [ Time Frame: baseline, 2 and 4 week ]
    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)

  4. Change in respiratory muscle function [ Time Frame: baseline, 2 and 4 week ]
    Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)

  5. Change in lung diffusion capacity [ Time Frame: baseline, 2 and 4 week ]
    Variation of Diffusing capacity (DLCO)

  6. Impact of the disease [ Time Frame: baseline, 2 and 4 week ]

    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


  7. Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES) [ Time Frame: baseline, 2 and 4 week ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04231058


Contacts
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Contact: Alessandro Tani, MD +39058891682 alessandro.tani@alice.it
Contact: Guido Vagheggini, MD +393473665513 guidovagheggini@libero.it

Locations
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Italy
Santa Maria Maddalena Hospital
Volterra, Pisa, Italy, 56048
Sponsors and Collaborators
Azienda USL Toscana Nord Ovest
Auxilium Vitae Volterra
Investigators
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Principal Investigator: Guido Vagheggini, MD Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS
Publications of Results:
Other Publications:
Celli BR, Decramer M, Wedzicha JA, Wilson KC, Agustí 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. Review.

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Responsible Party: Alessandro Tani, Doctor in Department of Anesthesia and Intensive Care Unit, Azienda USL Toscana Nord Ovest
ClinicalTrials.gov Identifier: NCT04231058    
Other Study ID Numbers: USL area vasta NordOvest
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessandro Tani, Azienda USL Toscana Nord Ovest:
COPD
Transcutaneous Electrical Nerve Stimulation
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Dyspnea
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory