The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Buddhist Dalin Tzuchi General Hospital

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04983784
• Other study ID #: B10903020
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2021
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Expected Results: Finding from this evidence-based study ought to clarify the effectiveness of walking intervention for patients with SLE, and provide reference for future nursing strategies to improve disease adaptability.

Description:

Background and purpose: Walking exercise may be grateful in strengthening the cardiopulmonary function, regulating the joint flexbility, relieving the pain and the disturbance of sleep, all of which can further improve the quality of life among the patients with chronic diseases. Nevertheless, the information regarding the effect of walking exercise amongst systemic lupus erythematosus (SLE) subjects is still obscure. This study aimed to the influence of quality of life and sleep after the implementation of walking exercise among such groups. uses the Psychometric evaluation of the Chinese version of the Pittsburgh Sleep QualityIndex、Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire and Systemic Lupus Disease Activity of Lupus Erythematosus Disease Activity Score and Taiwanese Depression Questionnaire to evaluate the effectiveness of the intervention of walking exercise on Systemic lupus erythematosus. Methods: Through the quasi-experimental study design, the investigators intend to recruit the SLE patients from a hospital in Taiwan between 2021-2022. The main intervention is composed of home walking, which contained walking guidance and telephone consultation. After that, the investigators apply the structured questionnaires and existing data to collect performance indicators, covering the Chinese version of Pittsburgh Sleep QualityIndex, Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire, Systemic Lupus Disease Activity of Lupus Erythematosus Disease Activity Score, and Taiwanese Depression Questionnaire. The effects of walking exercise is determined by The generalized estimation equations(GEE) .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• patients with fulfilled the American College of Rheumatology 1997 criteria for SLE

Exclusion Criteria:

• .patients with cardiovascular disease
• limited motion, such as bed-ridden, femur head necrosis
• were pregnant, or had a depressive disorder,

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• walking
walking for 12 weeks at home

Other:
• Routine care
Routine care

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi Hospital	Dalin

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	healthy quality of life Questionnaire	The investigators will assess the Lupus Quality of Life(LupusQoL), from 0 (worst HRQOL) to 100 (best HRQOL)	up to half a year
Secondary	score system of depression	The investigators will assess Taiwanese Depression Questionnaire (TDQ) The 18-item TDQ had a sensitivity of 0.89 and a specificity of 0.92 at a cutoff score of 19.	up to half a year
Secondary	quality of sleep	The investigators will assess Chinese version of Pittsburgh Sleep Quality Index (CPSQI) The CPSQI consists of 19 items that are used to generate seven component scores.; A global CPSQI score > 5 indicates that patients suffer from sleep disturbance.	up to half a year