The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

August 3, 2021 updated by: Dalin Tzu Chi General Hospital

Buddhist Dalin Tzuchi General Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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) .

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Dalin, Taiwan
        • Dalin Tzu Chi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: walking
walking for 12 weeks at home
Experimental: No intervention group reaction

control group:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healthy quality of life Questionnaire
Time Frame: up to half a year
The investigators will assess the Lupus Quality of Life(LupusQoL), from 0 (worst HRQOL) to 100 (best HRQOL)
up to half a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score system of depression
Time Frame: up to half a year
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
quality of sleep
Time Frame: up to half a year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalin Tzu Chi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 29, 2021

First Posted (Actual)

July 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B10903020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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