DyspneaCOPDNCT04231058
Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
A study testing TENS and pulmonary rehabilitation in people with Dyspnea, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- TENS and pulmonary rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
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).
Read the 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.
- Conditions
- Dyspnea
- Being tested
- TENS and pulmonary rehabilitation
- Keywords
- COPD, Transcutaneous Electrical Nerve Stimulation
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS and pulmonary rehabilitationDevice
Three treatments with TENS per week for 3 weeks each , lasting 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | 15 experimental subjects treated withTENS and Pulmonary Rehabilitation Receives: Device: TENS and pulmonary rehabilitation |
| Rehabilitation | No intervention | 15 experimental subjects treated with Pulmonary Rehabilitation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 2 week and 4 week
Secondary outcomes (7)
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
Measured: 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 .
Measured: 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)
Measured: baseline, 2 and 4 week
Change in respiratory muscle function
Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)
Measured: baseline, 2 and 4 week
Change in lung diffusion capacity
Variation of Diffusing capacity (DLCO)
Measured: 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
Measured: 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
Measured: baseline, 2 and 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: lack of sufficient staff to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Auxilium Vitae Volterra
- Responsible party
- Principal investigator, Alessandro Tani, Azienda USL Toscana Nord Ovest
- Investigators
- Guido Vagheggini, MD, Principal investigator, Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04231058
- Sponsor's protocol ID
- USL area vasta NordOvest
- Acronym
- COPD
- Status last verified
- Oct 2022
- First submitted
- 16 Dec 2019
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25087837Celli 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.
PubMed 26028628Montagnani 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.
PubMed 21596958Maltais 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.
PubMed 9032194Ngai 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.
PubMed 28303156Ngai 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.
PubMed 20601209Lau 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.
PubMed 18721121Yu 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.
PubMed 31517846Suzuki 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.
PubMed 22905352
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acu-TENS in the Non-pharmacological Treatment of Dyspnea in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT04231058
- Acronym / sponsor ID
- COPD / USL area vasta NordOvest
- Conditions
- Dyspnea
- Keywords
- COPD, Transcutaneous Electrical Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of sufficient staff to conduct the study
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- Auxilium Vitae Volterra
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | Device: TENS and pulmonary rehabilitation15 experimental subjects treated withTENS and Pulmonary Rehabilitation |
| Rehabilitation | No intervention | –15 experimental subjects treated with Pulmonary Rehabilitation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS and pulmonary rehabilitationThree treatments with TENS per week for 3 weeks each , lasting 45 minutes | Device | Transcutaneous Electrical Nerve Stimulation (TENS) |
Primary outcome
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
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).
7 secondary outcomes
Change in quality of life: SGRQ (St. George's Respiratory questionnaire)
Time frame: baseline ,2 week and 4 week
Change in functional capacity with the six-minute walk test (6mwt)
Time frame: baseline , 2 and 4 week
Change in respiratory volumes
Time frame: baseline, 2 and 4 week
Change in respiratory muscle function
Time frame: baseline, 2 and 4 week
Change in lung diffusion capacity
Time frame: baseline, 2 and 4 week
Impact of the disease
Time frame: baseline, 2 and 4 week
Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)
Time frame: baseline, 2 and 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 25087837Mazzoleni 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.
- Background: PubMed 26028628Celli 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.
- Background: PubMed 21596958Montagnani 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.
- Background: PubMed 9032194Maltais 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.
- Results publication: PubMed 28303156Ngai 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.
- Results publication: PubMed 20601209Ngai 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.
- Results publication: PubMed 18721121Lau 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.
- Results publication: PubMed 31517846Yu 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.
- Results publication: PubMed 22905352Suzuki 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Vagheggini, MD principal investigator
Azienda USL Toscana Nordovest, Fondazione Volterra Ricerche ONLUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and pulmonary rehabilitation in people with Dyspnea, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI) (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04231058, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.