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

Not Applicable

• Conditions: Hemodialysis
• Interventions: Other: Exercise education

• Registration Number: NCT03996811
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2019-06-23
• Study First Submitted QC: 2019-06-23
• Study Start: 2019-06-24
• Study First Posted: 2019-06-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-14
• Last Update Posted: 2021-03-16
• Primary Completion: 2022-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise group	Exercise education	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.

Primary Outcome Measures

Name	Time	Method
subjective quality of life	24rd month after recruited	using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™) to measure quality of life.

Secondary Outcome Measures

Name	Time	Method
objective cardiovascular health index	24rd month after recruited	serum
check Physical Functioning	24rd month after recruited	6MWT(Six Minute Walk Test)
subjective negative emotions	24rd month after recruited	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.

Trial Locations

Locations (1)

National Taipei University of Nursing and Health Sciences; 🇨🇳 Taipei, Taiwan