The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

NCT ID: NCT04983784

Last Updated: 2021-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-07-30

Brief Summary

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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

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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) .

Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The experiment group is composed of home walking, which contained walking guidance and telephone consultation, the control group without any intervention.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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The Effectiveness of Walking on Sleep ,Depression and Quality of Life on intervention

experimental group:

1. intervention home-style walking exercises
2. performed 12 weeks of 30 minutes walking exercise 2-3 times per week
3. assess on at baseline and 12 weeks

Group Type EXPERIMENTAL

walking

Intervention Type BEHAVIORAL

walking for 12 weeks at home

No intervention group reaction

control group:

1. no intervention
2. Routine care and follow-up
3. assess on at baseline and 12 weeks

Group Type EXPERIMENTAL

Routine care

Intervention Type OTHER

Routine care

Interventions

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walking

walking for 12 weeks at home

Intervention Type BEHAVIORAL

Routine care

Routine care

Intervention Type OTHER

Eligibility Criteria

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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,
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dalin Tzu Chi Hospital

Dalin, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B10903020

Identifier Type: -

Identifier Source: org_study_id

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