Clinical trial NCT03996811: The Effectiveness of Home-based Walking Program in Improving Quality of Life in Patients With Hemodialysis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2019-06-25
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: subjective quality of life
timeFrame: 3rd month after recruited
measure: subjective quality of life
timeFrame: 6rd month after recruited
measure: subjective quality of life
timeFrame: 12rd month after recruited
measure: subjective quality of life
timeFrame: 24rd month after recruited
Secondary outcomes:
measure: subjective negative emotions
timeFrame: 3rd month after recruited
measure: subjective negative emotions
timeFrame: 6rd month after recruited
measure: subjective negative emotions
timeFrame: 12rd month after recruited
measure: subjective negative emotions
timeFrame: 24rd month after recruited
measure: objective cardiovascular health index
timeFrame: 3rd month after recruited
measure: objective cardiovascular health index
timeFrame: 6rd month after recruited
measure: objective cardiovascular health index
timeFrame: 12rd month after recruited
measure: objective cardiovascular health index
timeFrame: 24rd month after recruited
measure: check Physical Functioning
timeFrame: 3rd month after recruited
measure: check Physical Functioning
timeFrame: 6rd month after recruited
measure: check Physical Functioning
timeFrame: 12rd month after recruited
measure: check Physical Functioning
timeFrame: 24rd month after recruited
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Hui-Mei Chen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Hsin-Ling Tai, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Jiu-Yun Tian, University
role: STUDY_DIRECTOR
References: