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

Not Applicable

Suspended

• Conditions: Dyspnea
• Interventions: Device: TENS and pulmonary rehabilitation

• Registration Number: NCT04231058
• Lead Sponsor: 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).

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.

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-18
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Study Start: 2024-05-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Transcutaneous Electrical Nerve Stimulation (TENS)	TENS and pulmonary rehabilitation	15 experimental subjects treated withTENS and Pulmonary Rehabilitation

Primary Outcome Measures

Name	Time	Method
Baseline dyspnea evaluated with Baseline Dyspnea Index (BDI)	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)	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

Name	Time	Method
Change in quality of life: SGRQ (St. George's Respiratory questionnaire)	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
Change in respiratory muscle function	baseline, 2 and 4 week	Variation of MIP (Maximal Inspiratory Pressure) and MEP (Maximal Expirator Pressure)
Change in lung diffusion capacity	baseline, 2 and 4 week	Variation of Diffusing capacity (DLCO)
Change in functional capacity with the six-minute walk test (6mwt)	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 .
Change in respiratory volumes	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)
Impact of the disease	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
Patient's dissociative experience related to the stress measured with the Dissociative Experiences Scale (DES)	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

Trial Locations

Locations (1)

Santa Maria Maddalena Hospital; 🇮🇹 Volterra, Pisa, Italy