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)
November 17, 2025 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Taiwan
-
Kaohsiung, Taiwan, Taiwan, 807378
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neuromuscular electrical stimulation
lower limb neuromuscular electrical stimulation
|
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,
The control group will only participate in pulmonary rehabilitation exercises
|
|
Other: routine treatment：Pulmonary rehabilitation exercises
The control group only participated in the lung rehabilitation exercise program (after which the control group received electrical stimulation for two months)
|
The control group only participated in the lung rehabilitation exercise program (after which the control group received electrical stimulation for two months)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change dyspnea during activity
Time Frame: 8 weeks
|
Modified Medical Research Council(mMRC)
|
8 weeks
|
|
Change exercise self-efficacy
Time Frame: 8 weeks
|
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 fatigue
Time Frame: 8 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Physical Performance Battery
Time Frame: 8 weeks
|
The project leader will collect data on the Short Physical Performance Battery (SPPB) before the intervention and eight weeks after the intervention.
If there is no pre-test data of the Short Physical Performance Battery (SPPB), the Short Physical Performance Battery (SPPB) will be administered again two months after the intervention.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
February 20, 2025
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
February 28, 2025
Study Record Updates
Last Update Posted (Actual)
November 20, 2025
Last Update Submitted That Met QC Criteria
November 17, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUHIRB-F(II)-20240343
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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