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NCT04231058 | Not yet recruiting | Dyspnea


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

Azienda USL Toscana Nord Ovest

Information provided by (Responsible Party):

Alessandro Tani

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

Dyspnea

Intervention/treatment

TENS and pulmonary rehabilitation

Phase

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: 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 Type : Interventional
Estimated Enrollment : 30 participants
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)
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 31, 2022
Arm Intervention/treatment

Experimental: Transcutaneous Electrical Nerve Stimulation (TENS)

15 experimental subjects treated withTENS and Pulmonary Rehabilitation

No Intervention: Rehabilitation

15 experimental subjects treated with Pulmonary Rehabilitation only

Ages Eligible for Study: 18 Years
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.

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

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

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Locations


Not yet recruiting

Italy, Pisa

Santa Maria Maddalena Hospital

Volterra, Pisa, Italy, 56048

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