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Completed

NCT Number: NCT05281497

Hemodialysis Health Management Model

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

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Key information

Conditions

Physical Inactivity Behavior Nutritional Wasting Sedentary Behavior

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wen-Yi Li

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Health platform

Behavioral

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

Behavioral

We built a LINE group to inspire the intervention group.

Exercise training

Other

exercise including walk and an 18-minutes calisthenics

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Change of KDQOL-SF

    Time frame: baseline, week 4, week 8, week 12, week 16 and week 24

    Quality of life measured by the KDQOL-SF (dialysis version)

  2. Change of subjective global assessment (SGA)

    Time frame: baseline, week 4, week 8, week 12, week 16 and week 24

    subjective global assessment for nutritional status

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Mar 16, 2022
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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