NCT03996811

Brief Summary

This study will investigate the effectiveness of a rehabilitation program in improving physical functioning, cardiovascular health index, negative emotions, and quality of life in patients with hemodialysis in Taiwan. Hypothesis:

  1. 1.The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  2. 2.The negative emotions in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  3. 3.The cardiovascular health index in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.
  4. 4.The Physical Functioning in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, and 24th month.

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
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 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

June 23, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

June 23, 2019

Last Update Submit

March 14, 2021

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (4)

  • subjective quality of life

    using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

    3rd month after recruited

  • subjective quality of life

    using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

    6rd month after recruited

  • subjective quality of life

    using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

    12rd month after recruited

  • subjective quality of life

    using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

    24rd month after recruited

Secondary Outcomes (12)

  • subjective negative emotions

    3rd month after recruited

  • subjective negative emotions

    6rd month after recruited

  • subjective negative emotions

    12rd month after recruited

  • subjective negative emotions

    24rd month after recruited

  • objective cardiovascular health index

    3rd month after recruited

  • +7 more secondary outcomes

Study Arms (2)

exercise group

EXPERIMENTAL

exercise education: A 12-week regimen of home-based walking exercises, include moderate intensity for 40 min, three times a week on non-dialysis days. We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the target heart rate, as determined by the Karvonen method, and 12-13 on the RPE.

Other: Exercise education

usual-care group

NO INTERVENTION

Hospital routine care

Interventions

Exercise educationOTHER

weekly telephone consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.

exercise group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with hemodialysis who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, 6-minute walking test ≧ 300m and not cognitively impaired were included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, 112, Taiwan

RECRUITING

Study Officials

  • Hui-Mei Chen, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

  • Hsin-Ling Tai, Master

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

  • Jiu-Yun Tian, University

    Taipei Veterans General Hospital, Taiwan

    STUDY DIRECTOR

Central Study Contacts

Hui-Mei Chen, PhD

CONTACT

886-939654302alice@ntunhs.edu.tw

Hsin-Ling Tai, Master

CONTACT

886-937546170hltai@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2019

First Posted

June 25, 2019

Study Start

June 24, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2023

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending 36 months following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.

Locations

TW(1)