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Enrolling By InvitationNCT06851195

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
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICElower limb neuromuscular electrical stimulationThe 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,
BEHAVIORALpulmonary rehabilitation exercisesThe control group only participated in the lung rehabilitation exercise program (after which the control group received electrical stimulation for two months)

Timeline

Start date
2025-02-25
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2025-02-28
Last updated
2025-11-20

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT06851195. Inclusion in this directory is not an endorsement.