Hemodialysis Health Management Model

Not Applicable

Completed

• Conditions: Physical Inactivity; Nutritional Wasting
• Interventions: Behavioral: Health platform; Behavioral: Social media; Other: Exercise training

• Registration Number: NCT05281497
• Lead Sponsor: National Taiwan University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2021-09-26
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-16
• Primary Completion: 2022-04-30
• Study Completion: 2023-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-16
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Exercise training	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.
Control group	Health platform	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.
Intervention group	Health platform	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.
Intervention group	Social media	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.

Primary Outcome Measures

Name	Time	Method
Change of sit-to-stand-10 (STS-10)	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)	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)	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	baseline, week 4, week 8, week 12, week 16 and week 24	the strength of hand drip measured by a dynamometer

Secondary Outcome Measures

Name	Time	Method
Change of KDQOL-SF	baseline, week 4, week 8, week 12, week 16 and week 24	Quality 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 24	subjective global assessment for nutritional status

Trial Locations

Locations (1)

Wen-Yi Li; 🇨🇳 Taipei, Taiwan