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Clinical Trials/NCT05281497
NCT05281497CompletedNot Applicable

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

National Taiwan University Hospital1 site in 1 country31 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
Change of sit-to-stand-10 (STS-10)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

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.

Intervention: Health platform (Behavioral)

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.

Intervention: Social media (Behavioral)

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.

Intervention: Exercise training (Other)

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.

Intervention: Health platform (Behavioral)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Change of KDQOL-SF(baseline, week 4, week 8, week 12, week 16 and week 24)
  • Change of subjective global assessment (SGA)(baseline, week 4, week 8, week 12, week 16 and week 24)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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