Physical InactivityNCT05281497
Hemodialysis Health Management Model
A study testing Health platform, Social media and Exercise training in people with Physical Inactivity and Nutritional Wasting, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Physical Inactivity, Nutritional Wasting
- What is being tested?
- Health platform, Social media and Exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2019to 28 Feb 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 20 years and older
- diagnosis of ESRD receiving maintenance HD for more than 3 months
Who cannot join
- inability to use a smartphone
- impaired walking capacity
- having a psychiatric disorder
- any hospitalization during the previous 3 months.
- has been changing dialysis modality or receiving renal transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
Read the detailed description
Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care.
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
Material and Methods: The investigators plan to recruit 30 CKD patients as trial subjects for intervention. The intervention included wearable devices and health management platform for 24 weeks. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators compare physical and laboratory examinations before and after the intervention.
- Conditions
- Physical Inactivity, Nutritional Wasting
- Being tested
- Health platform, Social media, Exercise training
- Keywords
- Hemodialysis, Wearable device, Health management platform
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health platformBehavioural
Each participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation). Each participant downloaded an app (WowGoHealth app) to connect with the health management platform (GSH AI health platform). Participants' exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected by the wearable devices. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics made by the Health Promotion Administration, Ministry of Health and Welfare (https://www.youtube.com/watch?v=r3xJW-b2tZY).
Social mediaBehavioural
We built a LINE group to inspire the intervention group.
Exercise trainingOther
exercise including walk and an 18-minutes calisthenics
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Each participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics. We also built a LINE group to inspire the intervention group. Receives: Behavioral: Health platform; Behavioral: Social media; Other: Exercise training |
| Control group | Placebo comparator | Each participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. We did not encourage exercise or build a LINE group. Receives: Behavioral: Health platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of sit-to-stand-10 (STS-10)
time to complete 10 sit-to-stand cycles
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Change of sit-to-stand-60 (STS-60)
the number of repetitions of sit-to-stand cycles achieved in 60 seconds
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Change of 6-minute walking distance (6MWT)
the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Change of hand grip strength
the strength of hand drip measured by a dynamometer
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Secondary outcomes (2)
Change of KDQOL-SF
Quality of life measured by the KDQOL-SF (dialysis version)
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Change of subjective global assessment (SGA)
subjective global assessment for nutritional status
Measured: baseline, week 4, week 8, week 12, week 16 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Jul 2019
- Primary completion30 Apr 2022
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention group and control group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Yi Li, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281497
- Sponsor's protocol ID
- 201812145RINA
- Status last verified
- Jun 2024
- First submitted
- 26 Sep 2021
- Last updated
- 18 Jun 2024
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention
- ClinicalTrials.gov ID
- NCT05281497
- Acronym / sponsor ID
- 201812145RINA
- Conditions
- Physical Inactivity, Nutritional Wasting
- Keywords
- Hemodialysis, Wearable device, Health management platform
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 16 Mar 2022 (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.
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
Detailed description
Background: End stage renal disease (ESRD) is a global public health issue. The dialysis therapy brings huge economic burden to many countries. If patients are able to monitor their lifestyle, it not only promotes health, but also reduces the cost of health care.
Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.
Material and Methods: The investigators plan to recruit 30 CKD patients as trial subjects for intervention. The intervention included wearable devices and health management platform for 24 weeks. Patients record their own diet diary by a smartphone application, and their exercise-related data are collected by wearable devices. Then, all the collected information will be upload to health management platform. The investigators compare physical and laboratory examinations before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Health platform, Behavioral: Social media, Other: Exercise trainingEach participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics. We also built a LINE group to inspire the intervention group. |
| Control group | Placebo comparator | Behavioral: Health platformEach participant was provided with a wearable device. Each participant downloaded an app (WowGoHealth app) to connect with the health management platform. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. We did not encourage exercise or build a LINE group. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 20 years and older
- diagnosis of ESRD receiving maintenance HD for more than 3 months
Key exclusion criteria (5 listed)
- inability to use a smartphone
- impaired walking capacity
- having a psychiatric disorder
- any hospitalization during the previous 3 months.
- has been changing dialysis modality or receiving renal transplantation
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 |
|---|---|---|
| Health platformEach participant was provided with a wearable device (a Heart Rate Smart Wristband, GSH405-B6, Golden Smart Home Technology Corporation). Each participant downloaded an app (WowGoHealth app) to connect with the health management platform (GSH AI health platform). Participants' exercise-related data, including number of steps walked, distance, consumed calories, and heart rate, were collected by the wearable devices. All participants were taught to record a dietary diary (taking photos of meals) using a smartphone application. All collected information was uploaded to the health management platform. For the intervention group, we encouraged exercise including an 18-minutes calisthenics made by the Health Promotion Administration, Ministry of Health and Welfare (https://www.youtube.com/watch?v=r3xJW-b2tZY). | Behavioural | Control group, Intervention group |
| Social mediaWe built a LINE group to inspire the intervention group. | Behavioural | Intervention group |
| Exercise trainingexercise including walk and an 18-minutes calisthenics | Other | Intervention group |
Primary outcome
Change of sit-to-stand-10 (STS-10)
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
time to complete 10 sit-to-stand cycles
Change of sit-to-stand-60 (STS-60)
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
the number of repetitions of sit-to-stand cycles achieved in 60 seconds
Change of 6-minute walking distance (6MWT)
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track
Change of hand grip strength
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
the strength of hand drip measured by a dynamometer
2 secondary outcomes
Change of KDQOL-SF
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
Change of subjective global assessment (SGA)
Time frame: baseline, week 4, week 8, week 12, week 16 and week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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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.
Wen-Yi Li study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health platform, Social media and Exercise training in people with Physical Inactivity and Nutritional Wasting, run by National Taiwan University 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change of sit-to-stand-10 (STS-10) (time frame: baseline, week 4, week 8, week 12, week 16 and week 24). The study lists 4 primary outcomes in all. 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 18 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.