The Effectiveness of Home-based Walking Program in Improving Quality of Life in Patients With Hemodialysis

The Effectiveness of Home-based Walking Program in Improving Physical Functioning, Cardiovascular Health Index, Negative Emotions, and Quality of Life in Patients With Hemodialysis

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

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis
• Intervention / Treatment: Other: Exercise education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUI-MEI CHEN, PhD; Phone Number: 886-939654302; Email: alice@ntunhs.edu.tw
• Study Contact Backup: Name: Hsin-Ling Tai, Master; Phone Number: 886-937546170; Email: hltai@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Recruiting
    • National Taipei University of Nursing and Health Sciences
    • Contact: HUI-MEI CHEN, PhD; Phone Number: 886-939654302; Email: alice@ntunhs.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise group; 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; 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.
No Intervention: usual-care group; Hospital routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
subjective negative emotions	negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	3rd month after recruited
subjective negative emotions	negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	6rd month after recruited
subjective negative emotions	negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	12rd month after recruited
subjective negative emotions	negative emotions including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	24rd month after recruited
objective cardiovascular health index	serum	3rd month after recruited
objective cardiovascular health index	serum	6rd month after recruited
objective cardiovascular health index	serum	12rd month after recruited
objective cardiovascular health index	serum	24rd month after recruited
check Physical Functioning	6MWT(Six Minute Walk Test)	3rd month after recruited
check Physical Functioning	6MWT(Six Minute Walk Test)	6rd month after recruited
check Physical Functioning	6MWT(Six Minute Walk Test)	12rd month after recruited
check Physical Functioning	6MWT(Six Minute Walk Test)	24rd month after recruited

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences; Principal Investigator: Hsin-Ling Tai, Master, Taipei Veterans General Hospital, Taiwan; Study Director: Jiu-Yun Tian, University, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2019
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): July 31, 2023

Study Registration Dates

• First Submitted: June 23, 2019
• First Submitted That Met QC Criteria: June 23, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 16, 2021
• Last Update Submitted That Met QC Criteria: March 14, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2019-06-003A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee (learned intermediary) identified for this purpose.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No