Hemodialysis Health Management Model

NCT05281497 | Completed

• 1 other identifier: 201812145RINA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Physical Inactivity; Nutritional Wasting

Keywords

Hemodialysis; Wearable device; Health management platform

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (2)

• 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

Study Arms (2)

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.

Behavioral: Health platform; Behavioral: Social media; Other: Exercise training

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.

Behavioral: Health platform

Interventions

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).

Control group; Intervention group

Social media BEHAVIORAL

We built a LINE group to inspire the intervention group.

Intervention group

Exercise training OTHER

exercise including walk and an 18-minutes calisthenics

Intervention group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Wen-Yi Li

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sedentary Behavior

Interventions

Media Exposure; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Sociology; Social Sciences; Behavioral Sciences; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Wen-Yi Li

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: intervention group and control group

Study Record Dates

• First Submitted: September 26, 2021
• First Posted: March 16, 2022
• Study Start: July 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: February 28, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

TW (1)