NCT04983784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

August 10, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

July 9, 2021

Last Update Submit

August 3, 2021

Conditions

Keywords

Quality of SleepQuality of LifeWalking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • score system of depression

    up to half a year

  • quality of sleep

    up to half a year

Study Arms (2)

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

EXPERIMENTAL

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

No intervention group reaction

EXPERIMENTAL

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

Other: Routine care

Interventions

walkingBEHAVIORAL

walking for 12 weeks at home

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

Routine care

No intervention group reaction

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dalin Tzu Chi Hospital

Dalin, Taiwan

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicSleep Initiation and Maintenance Disorders

Interventions

Walking

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The experiment group is composed of home walking, which contained walking guidance and telephone consultation, the control group without any intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 30, 2021

Study Start

November 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

August 10, 2021

Record last verified: 2021-08

Locations