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

NCT06851195 | Enrolling By Invitation

• 1 other identifier: KMUHIRB-F(II)-20240343
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change exercise self-efficacy

  This scale is used to assess an individual's confidence in performing exercise behaviors when faced with various situations that are not conducive to exercise. The Chinese version of the Sports Self-efficacy Scale consists of 10 questions, scored from 0 to 10, to understand the degree of confidence in engaging in sports. "0" represents little confidence, and "10" represents great confidence. The higher the score, the more confident one is in performing sports in the face of various situations and obstacles.

  8 weeks

• change dyspnea during activity

  Modified Medical Research Council(mMRC)

  8 weeks

• change fatigue

  The Manchester fatigue scale (MFS) is divided into three aspects, including fatigue conditions such as physiological level (11 questions), cognitive feelings (9 questions) and psychosocial function (7 questions). There are 27 questions in total, with a five-point scoring method. The scoring method is 1 point for "never", 2 points for "rarely", 3 points for "sometimes", 4 points for "often", and 5 points for "always". The higher the score, the higher the degree of fatigue.

  8 weeks

Secondary Outcomes (1)

• Short Physical Performance Battery

  8 weeks

Study Arms (2)

neuromuscular electrical stimulation

EXPERIMENTAL

lower limb neuromuscular electrical stimulation

routine treatment：Pulmonary rehabilitation exercises

OTHER

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

Behavioral: pulmonary rehabilitation exercises

Interventions

lower limb neuromuscular electrical stimulation DEVICE

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. Based on Hill et al. (2018), 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,

pulmonary rehabilitation exercises BEHAVIORAL

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

routine treatment：Pulmonary rehabilitation exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807378, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Fatigue

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)