Clinical trial NCT04983784: The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus
Official title: Buddhist Dalin Tzuchi General Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Quality of Sleep
Quality of Life
Walking
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The experiment group is composed of home walking, which contained walking guidance and telephone consultation, the control group without any intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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) .

Eligibility criteria: 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,

Primary outcomes:
measure: healthy quality of life Questionnaire
timeFrame: up to half a year
Secondary outcomes:
measure: score system of depression
timeFrame: up to half a year
measure: quality of sleep
timeFrame: up to half a year
Other outcomes:
Locations:
city: Dalin
country: Taiwan
facility: Dalin Tzu Chi Hospital
Study officials:
References: