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

Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03996811
• Other study ID #: 2019-06-003A
• Status: Recruiting
• Phase: N/A
• Start date: June 24, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2021
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Hui-Mei Chen, PhD
• Phone: 886-939654302
• Email: alice[@]ntunhs.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Hemodialysis

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taipei University of Nursing and Health Sciences	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subjective quality of life	using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.	3rd month after recruited
Primary	subjective quality of life	using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.	6rd month after recruited
Primary	subjective quality of life	using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.	12rd month after recruited
Primary	subjective quality of life	using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.	24rd month after recruited
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	objective cardiovascular health index	serum	3rd month after recruited
Secondary	objective cardiovascular health index	serum	6rd month after recruited
Secondary	objective cardiovascular health index	serum	12rd month after recruited
Secondary	objective cardiovascular health index	serum	24rd month after recruited
Secondary	check Physical Functioning	6MWT(Six Minute Walk Test)	3rd month after recruited
Secondary	check Physical Functioning	6MWT(Six Minute Walk Test)	6rd month after recruited
Secondary	check Physical Functioning	6MWT(Six Minute Walk Test)	12rd month after recruited
Secondary	check Physical Functioning	6MWT(Six Minute Walk Test)	24rd month after recruited