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The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
walking
Routine care
Sponsored by
Dalin Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Systemic Lupus Erythematosus focused on measuring Quality of Sleep, Quality of Life, Walking

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Dalin Tzu Chi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

No intervention group reaction

Arm Description

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

control group: no intervention Routine care and follow-up assess on at baseline and 12 weeks

Outcomes

Primary Outcome Measures

healthy quality of life Questionnaire
The investigators will assess the Lupus Quality of Life(LupusQoL), from 0 (worst HRQOL) to 100 (best HRQOL)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 9, 2021
Last Updated
August 3, 2021
Sponsor
Dalin Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04983784
Brief Title
The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus
Official Title
Buddhist Dalin Tzuchi General Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalin Tzu Chi General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Quality of Sleep, Quality of Life, Walking

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The experiment group is composed of home walking, which contained walking guidance and telephone consultation, the control group without any intervention.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The Effectiveness of Walking on Sleep ,Depression and Quality of Life on intervention
Arm Type
Experimental
Arm Description
experimental group: intervention home-style walking exercises performed 12 weeks of 30 minutes walking exercise 2-3 times per week assess on at baseline and 12 weeks
Arm Title
No intervention group reaction
Arm Type
Experimental
Arm Description
control group: no intervention Routine care and follow-up assess on at baseline and 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
walking
Intervention Description
walking for 12 weeks at home
Intervention Type
Other
Intervention Name(s)
Routine care
Intervention Description
Routine care
Primary Outcome Measure Information:
Title
healthy quality of life Questionnaire
Description
The investigators will assess the Lupus Quality of Life(LupusQoL), from 0 (worst HRQOL) to 100 (best HRQOL)
Time Frame
up to half a year
Secondary Outcome Measure Information:
Title
score system of depression
Description
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.
Time Frame
up to half a year
Title
quality of sleep
Description
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.
Time Frame
up to half a year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Dalin Tzu Chi Hospital
City
Dalin
Country
Taiwan

12. IPD Sharing Statement

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The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus

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