Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD) (COPD)
Primary Purpose
Dyspnea
Status
Suspended
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TENS and pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Dyspnea focused on measuring COPD, Transcutaneous Electrical Nerve Stimulation
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.
Sites / Locations
- Santa Maria Maddalena Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Transcutaneous Electrical Nerve Stimulation (TENS)
Rehabilitation
Arm Description
15 experimental subjects treated withTENS and Pulmonary Rehabilitation
15 experimental subjects treated with Pulmonary Rehabilitation only
Outcomes
Primary Outcome Measures
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
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).
Secondary Outcome Measures
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
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 .
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)
Change in respiratory muscle function
Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)
Change in lung diffusion capacity
Variation of Diffusing capacity (DLCO)
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
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
Full Information
NCT ID
NCT04231058
First Posted
December 16, 2019
Last Updated
October 20, 2022
Sponsor
Azienda USL Toscana Nord Ovest
Collaborators
Auxilium Vitae Volterra
1. Study Identification
Unique Protocol Identification Number
NCT04231058
Brief Title
Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
COPD
Official Title
The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
lack of sufficient staff to conduct the study
Study Start Date
May 1, 2024 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Toscana Nord Ovest
Collaborators
Auxilium Vitae Volterra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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;
Abdominal, upper- and lower-limb muscle activities involving lifting of progressively increasing light weight and shoulder and full-arm circling;
Education;
Nutritional programs and psychosocial counselling, when appropriate. A multidisciplinary team of chest physicians, nurses, physical therapists, a dietician, and a psychologist offered care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea
Keywords
COPD, Transcutaneous Electrical Nerve Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Electrical Nerve Stimulation (TENS)
Arm Type
Experimental
Arm Description
15 experimental subjects treated withTENS and Pulmonary Rehabilitation
Arm Title
Rehabilitation
Arm Type
No Intervention
Arm Description
15 experimental subjects treated with Pulmonary Rehabilitation only
Intervention Type
Device
Intervention Name(s)
TENS and pulmonary rehabilitation
Intervention Description
Three treatments with TENS per week for 3 weeks each , lasting 45 minutes
Primary Outcome Measure Information:
Title
Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)
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
Time Frame
baseline
Title
Transitional dyspnea evaluated with Transitional Dyspnea Index (TDI)
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).
Time Frame
2 week and 4 week
Secondary Outcome Measure Information:
Title
Change in quality of life: SGRQ (St. George's Respiratory questionnaire)
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
Time Frame
baseline ,2 week and 4 week
Title
Change in functional capacity with the six-minute walk test (6mwt)
Description
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes .
Time Frame
baseline , 2 and 4 week
Title
Change in respiratory volumes
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)
Time Frame
baseline, 2 and 4 week
Title
Change in respiratory muscle function
Description
Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)
Time Frame
baseline, 2 and 4 week
Title
Change in lung diffusion capacity
Description
Variation of Diffusing capacity (DLCO)
Time Frame
baseline, 2 and 4 week
Title
Impact of the disease
Description
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
Time Frame
baseline, 2 and 4 week
Title
Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)
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.
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
Time Frame
baseline, 2 and 4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guido Vagheggini, MD
Organizational Affiliation
Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santa Maria Maddalena Hospital
City
Volterra
State/Province
Pisa
ZIP/Postal Code
56048
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25087837
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.
Results Reference
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26028628
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.
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PubMed Identifier
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PubMed Identifier
9032194
Citation
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Citation
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Citation
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Learn more about this trial
Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
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