Hemodialysis Health Management Model

Physical Inactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281497
• Other study ID #: 201812145RINA
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: February 28, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim: By application of wearable devices and health management platform to strengthen physical activity and improved life quality in hemodialysis patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 28, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Nutritional Wasting
• Physical Inactivity

Intervention

Behavioral:
• Health 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).
• Social media
We built a LINE group to inspire the intervention group.

Other:
• exercise including an 18-minutes calisthenics
exercise including an 18-minutes calisthenics

Locations

Country	Name	City	State
Taiwan	Wen-Yi Li	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of sit-to-stand-10 (STS-10)	time to complete 10 sit-to-stand cycles	baseline, week 4, week 8, week 12, week 16 and week 24
Primary	Change of sit-to-stand-60 (STS-60)	the number of repetitions of sit-to-stand cycles achieved in 60 seconds	baseline, week 4, week 8, week 12, week 16 and week 24
Primary	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	baseline, week 4, week 8, week 12, week 16 and week 24
Primary	Change of hand grip strength	the strength of hand drip measured by a dynamometer	baseline, week 4, week 8, week 12, week 16 and week 24
Secondary	Change of KDQOL-SF	Quality of life measured by the KDQOL-SF (dialysis version)	baseline, week 4, week 8, week 12, week 16 and week 24
Secondary	Change of subjective global assessment (SGA)	subjective global assessment for nutritional status	baseline, week 4, week 8, week 12, week 16 and week 24