NCT04022590

Brief Summary

Investigators assume that the wearable clothes can be applied to home-based health care and integrated into a case management model through telehealthcare. While prior to complete the case management, the feasibility should be tested and evaluate its reliability and validity of the physical information collected from the clothes. Therefore, investigators try to conduct a feasibility study to evaluate the reliability and validity of the exercise heart rate sensing e-clothes and after that, investigators will incorporate this wearable clothes to home-based exercise training as one of the major components in our case management model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

5.2 years

First QC Date

May 18, 2019

Last Update Submit

September 29, 2023

Conditions

Degeneration MuscleMultiple MorbiditiesHeart; Complications

Outcome Measures

Primary Outcomes (5)

  • Aerobic capacity (VO2 max in ml/kg/min )

    Maximal VO2 during testing, also means aerobic capacity

    30 minutes

  • Working load in watt

    Maximal Working load during testing

    30 minutes

  • Rest/Max Heart rate in beat/min

    resting and maximal heart rate during exercise testing,

    30 minutes

  • O2 pulse in ml/beat,

    It means the heart pumps O2 volume by each heart beat, and also means left ventricle function.

    30 minutes

  • systolic and diastolic blood pressure in mm Hg,

    The resting and maximal blood pressure during exercise testing

    30 minutes

Secondary Outcomes (1)

  • Physical activity (scores)

    10 minutes

Other Outcomes (2)

  • Quality of life (scores)

    20 minutes

  • Depression (scores)

    10 minnutes

Study Arms (2)

E-clothes

EXPERIMENTAL

The participants with E-clothes do aerobic training at home

Device: E-clothesBehavioral: Healthy consultation

Home exercise

ACTIVE COMPARATOR

The participants with healthy consultation do aerobic training at home.

Behavioral: Healthy consultation

Interventions

E-clothesDEVICE

The E-clothes could prove heart rate or heart rate variability(HRV) information to the participants' smart phone by blue tooth. Then the smart phone will calculate and provide the suitable aerobic training intensity by the microphone when the participants do aerobic training.

E-clothes
Healthy consultationBEHAVIORAL

Healthy consultation will educate the participants do aerobic training three times a week for 3 months. And the each training period is at least 30 minutes.

E-clothesHome exercise

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than two chronic disease.(multiple morbidity)
  • able to speak and understand Mandarin
  • able to walk without assistance
  • able to use smart phones and understand how to use the e-clothes and related app
  • agreed to be randomized to one of the two groups

You may not qualify if:

  • a history of cancer
  • confirmed psychiatric disease
  • inability to participate due to comorbid neurological and musculoskeletal conditions
  • a history of arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-service General Hospital

Taipei, 115, Taiwan

RECRUITING

Central Study Contacts

Shang-Lin Chiang, PhD

CONTACT

8860287923311andyyy520@yahoo.com.tw

Liang-Hsuan Lu, MS

CONTACT

8860287923311katelinana@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

May 18, 2019

First Posted

July 17, 2019

Study Start

July 8, 2019

Primary Completion

August 31, 2024

Study Completion

December 31, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)