Systemic Lupus ErythematosusNCT04983784
The Effectiveness of Walking in Patients With Systemic Lupus Erythematosus
A study testing walking and Routine care in people with Systemic Lupus Erythematosus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- walking and Routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with fulfilled the American College of Rheumatology 1997 criteria for SLE
Who cannot join
- .patients with cardiovascular disease
- limited motion, such as bed-ridden, femur head necrosis
- were pregnant, or had a depressive disorder,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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) .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- walking, Routine care
- Keywords
- Quality of Sleep, Quality of Life, Walking
- Medical subject headings
- Lupus Erythematosus, Systemic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walkingBehavioural
walking for 12 weeks at home
Routine careOther
Routine care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
healthy quality of life Questionnaire
The investigators will assess the Lupus Quality of Life(LupusQoL), from 0 (worst HRQOL) to 100 (best HRQOL)
Measured: up to half a year
Secondary outcomes (2)
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.
Measured: up to half a year
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.
Measured: up to half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Nov 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983784
- Sponsor's protocol ID
- B10903020
- Status last verified
- Aug 2021
- First submitted
- 9 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buddhist Dalin Tzuchi General Hospital
- ClinicalTrials.gov ID
- NCT04983784
- Acronym / sponsor ID
- B10903020
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Quality of Sleep, Quality of Life, Walking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experiment group is composed of home walking, which contained walking guidance and telephone consultation, the control group without any intervention.
| Arm | Type | Receives |
|---|---|---|
| The Effectiveness of Walking on Sleep ,Depression and Quality of Life on intervention | Experimental | Behavioral: walkingexperimental 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 |
| No intervention group reaction | Experimental | Other: Routine carecontrol group: 1. no intervention 2. Routine care and follow-up 3. assess on at baseline and 12 weeks |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with fulfilled the American College of Rheumatology 1997 criteria for SLE
Key exclusion criteria (3 listed)
- .patients with cardiovascular disease
- limited motion, such as bed-ridden, femur head necrosis
- were pregnant, or had a depressive disorder,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walkingwalking for 12 weeks at home | Behavioural | The Effectiveness of Walking on Sleep ,Depression and Quality of Life on intervention |
| Routine careRoutine care | Other | No intervention group reaction |
Primary outcome
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)
2 secondary outcomes
score system of depression
Time frame: up to half a year
quality of sleep
Time frame: up to half a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walking and Routine care in people with Systemic Lupus Erythematosus, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healthy quality of life Questionnaire (time frame: up to half a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.