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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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06851195
Acronym
NMES
Enrollment
40
Registered
2025-02-28
Start date
2025-02-25
Completion date
2026-12-31
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

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

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Change exercise self-efficacy8 weeksThis 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.
change dyspnea during activity8 weeksModified Medical Research Council(mMRC)
change fatigue8 weeksThe 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.

Secondary

MeasureTime frameDescription
Short Physical Performance Battery8 weeksThe 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026