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Hemodialysis Health Management Model

Hemodialysis Health Management Model - the Application of Wearable Devices, Exercise and Nutritional Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05281497
Enrollment
31
Registered
2022-03-16
Start date
2019-07-01
Completion date
2023-02-28
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional Wasting, Physical Inactivity

Keywords

Hemodialysis, Wearable device, Health management platform

Brief summary

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.

Interventions

BEHAVIORALHealth platform

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).

BEHAVIORALSocial media

We built a LINE group to inspire the intervention group.

OTHERExercise training

exercise including walk and an 18-minutes calisthenics

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

intervention group and control group

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* age 20 years and older * diagnosis of ESRD receiving maintenance HD for more than 3 months

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change of sit-to-stand-10 (STS-10)baseline, week 4, week 8, week 12, week 16 and week 24time to complete 10 sit-to-stand cycles
Change of sit-to-stand-60 (STS-60)baseline, week 4, week 8, week 12, week 16 and week 24the number of repetitions of sit-to-stand cycles achieved in 60 seconds
Change of 6-minute walking distance (6MWT)baseline, week 4, week 8, week 12, week 16 and week 24the distance the participants walk as fast as they could for 6 minutes on a flat 30-meter track
Change of hand grip strengthbaseline, week 4, week 8, week 12, week 16 and week 24the strength of hand drip measured by a dynamometer

Secondary

MeasureTime frameDescription
Change of KDQOL-SFbaseline, week 4, week 8, week 12, week 16 and week 24Quality of life measured by the KDQOL-SF (dialysis version)
Change of subjective global assessment (SGA)baseline, week 4, week 8, week 12, week 16 and week 24subjective global assessment for nutritional status

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026