Effect of Neuromuscular Electrical Stimulation of Lower Limbs on Improving Exercise Self-Efficacy, Dyspnea During Activity and Fatigue in Patients With Chronic Obstructive Pulmonary Disease (NMES)

Kaohsiung Medical University

Status: Invitation-only

Conditions: Neuromuscular Electrical Stimulation (NMES); Dyspnea During Activity; Fatigue; Chronic Obstructive Pulmonary Disease (COPD); Exercise Self-Efficacy

Treatments: Device: lower limb neuromuscular electrical stimulation; Behavioral: pulmonary rehabilitation exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT06851195

KMUHIRB-F(II)-20240343

Details and patient eligibility

About

Patients diagnosed with COPD who meet the inclusion and exclusion criteria, either inpatients or outpatients, will be informed about the study'sstudy's purpose and procedures by the principal investigator. After understanding their rights, they will provide informed consent.

Full description

The process of the experiment The study adopts a quasi-experimental design with convenience sampling. Data collection will be done through structured questionnaires. Patients who meet the inclusion criteria will be referred by physicians, and before enrollment, a verbal introduction will be given explaining the study's purpose, the questionnaire, and the intervention procedure and duration. The experimental group will participate in both pulmonary rehabilitation exercises and an additional intervention of lower limb neuromuscular electrical stimulation, 30 minutes per session, three times per week, for eight weeks. The control group will only participate in pulmonary rehabilitation exercises. Neuromuscular electrical stimulation should continue for 4 to 8 weeks. Questionnaires will be administered before the intervention and at the 2nd, 4th, 6th, and 8th weeks post-intervention, including basic information, Modified Medical Research Council Dyspnea Scale, Manchester COPD Fatigue Scale, and Self-Efficacy for Exercise Scale. Data collection will take approximately 25 minutes, and questionnaires will be personally retrieved by the researcher.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with COPD as per pulmonary function reports, with post-bronchodilator FEV1/FVC ratio < 0.7, confirmed as mild to severe COPD by physician, without acute exacerbation, aged 18 or above, enrolled in a pulmonary rehabilitation program, able to communicate clearly in Mandarin or Taiwanese, and without history of a psychiatric disorders.

Exclusion criteria

• Patients unable to comply with long-term follow-up for lower limb neuromuscular electrical stimulation intervention, those with cardiac pacemakers, lower limb bone, joint, or neuromuscular diseases, obesity (BMI >35 kg/m2), or systemic vascular diseases (e.g., lupus erythematosus).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

neuromuscular electrical stimulation

Experimental group

Description:

lower limb neuromuscular electrical stimulation

routine treatment：Pulmonary rehabilitation exercises

Other group

Description:

The control group only participated in the lung rehabilitation exercise program (after which the control group received electrical stimulation for two months)

Treatment:

Behavioral: pulmonary rehabilitation exercises